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HL7 · Sep 3, 2024 · d5021e8 · d5021e8
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diff --git a/input/fsh/AL_USCore.fsh b/input/fsh/AL_USCore.fsh
@@ -7,9 +7,10 @@ Alias:   USCorePractitioner = http://hl7.org/fhir/us/core/StructureDefinition/us
 Alias:   USCoreProcedure = http://hl7.org/fhir/us/core/StructureDefinition/us-core-procedure
 Alias:   USCoreObservationLab = http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab
 Alias:   USCoreOrganization = http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization
-Alias:   USCoreClinicalTest = http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-test
+Alias:   USCoreClinicalResult = http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result
 Alias:   USCoreVitalSigns = http://hl7.org/fhir/us/core/StructureDefinition/us-core-vital-signs
-Alias:   USCoreObservationImaging = http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-imaging
+Alias:   USCoreObservationSimple = http://hl7.org/fhir/us/core/StructureDefinition/us-core-simple-observation
+Alias:   USCoreSpecimen = http://hl7.org/fhir/us/core/StructureDefinition/us-core-specimen
 
 // Extensions
 Alias:   USCoreBirthSex = http://hl7.org/fhir/us/core/StructureDefinition/us-core-birthsex

diff --git a/input/fsh/EX_Basic.fsh b/input/fsh/EX_Basic.fsh
@@ -25,7 +25,7 @@ Description: "Example of Primary Cancer Condition - hematologic cancer"
 * onsetDateTime = "2020-05-12"
 * asserter = Reference(us-core-practitioner-kyle-anydoc)
 * stage.summary = NCIT#C80135 "Binet Stage B"
-* stage.assessment = Reference(binet-stage-group-B)
+//* stage.assessment = Reference(binet-stage-group-B)
 
 Instance: secondary-cancer-condition-brain-mets
 InstanceOf: SecondaryCancerCondition
@@ -62,6 +62,7 @@ Description: "Example of Cancer-Related Comorbidities"
 // absent
 * extension[comorbidConditionAbsent][0].valueCodeableConcept = SCT#414916001 "Obesity (disorder)"
 * extension[comorbidConditionAbsent][1].valueCodeableConcept = SCT#19829001 "Disorder of lung (disorder)"
+* category = ObsCat#social-history "Social History"
 
 Instance: john-anyperson-chf
 InstanceOf: USCoreCondition
@@ -196,6 +197,7 @@ Description: "Example of ECOG Performance Status"
 * performer = Reference(us-core-practitioner-kyle-anydoc)
 * valueInteger = 0
 * interpretation = LNC#LA9622-7 "Fully active, able to carry on all pre-disease performance without restriction"
+* category = ObsCat#survey "Survey"
 
 Instance: karnofsky-performance-status-normal-activity
 InstanceOf: KarnofskyPerformanceStatus
@@ -208,7 +210,7 @@ Description: "Example of Karnofsky Performance Status"
 * performer = Reference(us-core-practitioner-kyle-anydoc)
 * valueInteger = 90
 * interpretation = LNC#LA29176-7 "Able to carry on normal activity; minor signs or symptoms of disease"
-
+* category = ObsCat#survey "Survey"
 
 Instance: cancer-related-surgical-procedure-lobectomy
 InstanceOf: CancerRelatedSurgicalProcedure
@@ -248,6 +250,7 @@ Description: "Example of TNM Clinical Stage Group"
 * hasMember[0] = Reference(tnm-clinical-primary-tumor-category-cT3)
 * hasMember[1] = Reference(tnm-clinical-regional-nodes-category-cN3)
 * hasMember[2] = Reference(tnm-clinical-distant-metastases-category-cM0)
+* category = ObsCat#imaging "Imaging"
 
 Instance: tnm-clinical-distant-metastases-category-cM0
 InstanceOf: TNMDistantMetastasesCategory
@@ -260,6 +263,7 @@ Description: "Example of TNM Clinical Distant Metastases Category"
 * performer = Reference(us-core-practitioner-kyle-anydoc)
 * effectiveDateTime = "2019-04-01"
 * valueCodeableConcept = SCT#1229901006 "American Joint Committee on Cancer cM0 (qualifier value)"
+* category = ObsCat#imaging "Imaging"
 
 Instance: tnm-clinical-primary-tumor-category-cT3
 InstanceOf: TNMPrimaryTumorCategory
@@ -272,6 +276,7 @@ Description: "Example of TNM Clinical Primary Tumor Category"
 * subject = Reference(cancer-patient-john-anyperson)
 * performer = Reference(us-core-practitioner-kyle-anydoc)
 * effectiveDateTime = "2019-04-01"
+* category = ObsCat#imaging "Imaging"
 
 Instance: tnm-clinical-regional-nodes-category-cN3
 InstanceOf: TNMRegionalNodesCategory
@@ -284,6 +289,7 @@ Description: "Example of TNM Clinical Regional Nodes Category"
 * subject = Reference(cancer-patient-john-anyperson)
 * performer = Reference(us-core-practitioner-kyle-anydoc)
 * effectiveDateTime = "2019-04-01"
+* category = ObsCat#imaging "Imaging"
 
 Instance: cancer-related-medication-request-gefitinib
 InstanceOf: CancerRelatedMedicationRequest
@@ -351,6 +357,7 @@ Description: "Hemoglobin lab result to support TNMStageGroup example"
 * effectiveDateTime = "2020-03-06"
 * performer = Reference(us-core-practitioner-owen-oncologist)
 * valueQuantity = 13.5 'g/dl' "g/dl"
+* category = ObsCat#laboratory "laboratory"
 
 Instance: history-of-cancer-metastatic-to-liver
 InstanceOf: HistoryOfMetastaticCancer
@@ -360,6 +367,7 @@ Description: "Example showing history of metastatic cancer in liver."
 * subject = Reference(cancer-patient-adam-everyman)
 * effectiveDateTime = "2018-11-16"
 * performer = Reference(us-core-practitioner-owen-oncologist)
+* category = ObsCat#social-history "Social History"
 
 Instance: no-history-of-metastatic-cancer 
 InstanceOf: HistoryOfMetastaticCancer
@@ -370,6 +378,7 @@ Description: "Example showing no history of metastatic cancer"
 * effectiveDateTime = "2018-11-16"
 * performer = Reference(us-core-practitioner-owen-oncologist)
 * valueBoolean = false
+* category = ObsCat#social-history "Social History"
 
 Instance: histologic-behavior-and-type-non-small-cell
 InstanceOf: HistologicBehaviorAndType
@@ -406,6 +415,7 @@ Description: "Example of intermediate histologic grade."
 //* status = #final "final"
 //* issued = "2019-04-15T13:28:17.239+02:00"
 
+/*
 Instance: rhabdomyosarcoma-risk-assessment-low
 InstanceOf: RhabdomyosarcomaRiskAssessment
 Description: "Example of rhabdomyosarcoma with a low risk assessment."
@@ -416,7 +426,6 @@ Description: "Example of rhabdomyosarcoma with a low risk assessment."
 * effectiveDateTime = "2021-04-01"
 * performer = Reference(us-core-practitioner-kyle-anydoc)
 
-
 Instance: all-risk-assessment-high
 InstanceOf: ALLRiskAssessment
 Description: "Example of leukemia with a standard risk assessment."
@@ -426,6 +435,7 @@ Description: "Example of leukemia with a standard risk assessment."
 * focus = Reference(primary-cancer-condition-nonspecific)
 * effectiveDateTime = "2021-04-01"
 * performer = Reference(us-core-practitioner-kyle-anydoc)
+*/
 
 Instance: john-anyperson-hd
 InstanceOf: USCoreCondition
@@ -462,6 +472,7 @@ Description: "Example of Patient"
 * extension[USCoreEthnicity].extension[text].valueString = "Not Hispanic or Latino"
 * extension[USCoreBirthSex].valueCode = #F
 
+/*
 Instance: lansky-play-performance-status-twenty
 InstanceOf: LanskyPlayPerformanceStatus
 Description: "Example of Lansky Play Performance Status."
@@ -483,6 +494,7 @@ Description: "Example of Deauville Scale."
 * interpretation = NCIT#C99750 "London Deauville Criteria Point Scale 5"
 * status = #final "final"
 * effectiveDateTime = "2019-04-01"
+*/
 
 Instance: body-surface-area-example
 InstanceOf: BodySurfaceArea

diff --git a/input/fsh/EX_ExtendedExample.fsh b/input/fsh/EX_ExtendedExample.fsh
@@ -160,6 +160,7 @@ Description: "mCODE Example for Cancer-Related Comorbidities"
 // absent -- These could also be references, but having a resource representing a non-condition would be unusual
 * extension[comorbidConditionAbsent][0].valueCodeableConcept = SCT#414916001 "Obesity (disorder)"
 * extension[comorbidConditionAbsent][1].valueCodeableConcept = SCT#19829001 "Disorder of lung (disorder)"
+* category = ObsCat#social-history "Social History"
 
 /* Not used -- model of comorbidities as Questionnaire
 Instance: cancer-related-comorbidity-response-jenny-m
@@ -195,6 +196,7 @@ Description: "Extended example: example showing ECOG performance status"
 * valueInteger = 0
 * interpretation = LNC#LA9622-7 "Fully active, able to carry on all pre-disease performance without restriction"
 * method = SCT#5880005 "Physical examination procedure (procedure)"
+* category = ObsCat#survey "Survey"
 
 // body weight and height added to calculate BSA needed to convert chemotherapy relative dose orders to absolute doses for CancerRelatedMedicationAdministration
 
@@ -248,6 +250,7 @@ Description: "Extended example: example showing TNM staging (stage group)"
 * hasMember[1] = Reference(tnm-pathologic-regional-nodes-category-jenny-m)
 * hasMember[2] = Reference(tnm-pathologic-distant-metastases-category-jenny-m)
 * performer = Reference(us-core-practitioner-owen-oncologist)
+* category = ObsCat#imaging "Imaging"
 
 Instance: tnm-clinical-primary-tumor-category-jenny-m
 InstanceOf: TNMPrimaryTumorCategory
@@ -260,6 +263,8 @@ Description: "Extended example: example showing TNM staging (T)"
 * valueCodeableConcept = SCT#1228938002 "American Joint Committee on Cancer cT3 (qualifier value)"
 * method = SCT#897275008 "American Joint Commission on Cancer, Cancer Staging Manual, 8th edition neoplasm staging system (tumor staging)"
 * performer = Reference(us-core-practitioner-owen-oncologist)
+* category = ObsCat#imaging "Imaging"
+
 
 Instance: tnm-clinical-regional-nodes-category-jenny-m
 InstanceOf: TNMRegionalNodesCategory
@@ -272,6 +277,7 @@ Description: "Extended example: example showing TNM staging (N)"
 * valueCodeableConcept = SCT#1229967007 "American Joint Committee on Cancer cN0 (qualifier value)"
 * method = SCT#897275008 "American Joint Commission on Cancer, Cancer Staging Manual, 8th edition neoplasm staging system (tumor staging)"
 * performer = Reference(us-core-practitioner-owen-oncologist)
+* category = ObsCat#imaging "Imaging"
 
 Instance: tnm-clinical-distant-metastases-category-jenny-m
 InstanceOf: TNMDistantMetastasesCategory
@@ -284,6 +290,7 @@ Description: "Extended example: example showing TNM staging (M)"
 * valueCodeableConcept = SCT#1229901006 "American Joint Committee on Cancer cM0 (qualifier value)"
 * method = SCT#897275008 "American Joint Commission on Cancer, Cancer Staging Manual, 8th edition neoplasm staging system (tumor staging)"
 * performer = Reference(us-core-practitioner-owen-oncologist)
+* category = ObsCat#imaging "Imaging"
 
 // Tumor marker test results 3-16-2018
 
@@ -503,6 +510,7 @@ Description: "Extended example: example showing TNM staging (stage group)"
 * hasMember[1] = Reference(tnm-pathologic-regional-nodes-category-jenny-m)
 * hasMember[2] = Reference(tnm-pathologic-distant-metastases-category-jenny-m)
 * performer = Reference(us-core-practitioner-owen-oncologist)
+* category = ObsCat#imaging "Imaging"
 
 Instance: tnm-pathologic-primary-tumor-category-jenny-m
 InstanceOf: TNMPrimaryTumorCategory
@@ -515,6 +523,7 @@ Description: "Extended example: example showing TNM staging (T)"
 * valueCodeableConcept = SCT#1229859000 "American Joint Committee on Cancer pT3 (qualifier value)"
 * method = SCT#897275008 "American Joint Commission on Cancer, Cancer Staging Manual, 8th edition neoplasm staging system (tumor staging)"
 * performer = Reference(us-core-practitioner-owen-oncologist)
+* category = ObsCat#imaging "Imaging"
 
 Instance: tnm-pathologic-regional-nodes-category-jenny-m
 InstanceOf: TNMRegionalNodesCategory
@@ -527,6 +536,7 @@ Description: "Extended example: example showing TNM staging (N)"
 * valueCodeableConcept = SCT#1229947003 "American Joint Committee on Cancer pN0 (qualifier value)"
 * method = SCT#897275008 "American Joint Commission on Cancer, Cancer Staging Manual, 8th edition neoplasm staging system (tumor staging)"
 * performer = Reference(us-core-practitioner-owen-oncologist)
+* category = ObsCat#imaging "Imaging"
 
 Instance: tnm-pathologic-distant-metastases-category-jenny-m
 InstanceOf: TNMDistantMetastasesCategory
@@ -539,6 +549,7 @@ Description: "Extended example: example showing TNM staging (M)"
 * valueCodeableConcept = AbsentReason#not-applicable "Not Applicable"   // cancer is not metastatic, pM0 is not valid
 * method = SCT#897275008 "American Joint Commission on Cancer, Cancer Staging Manual, 8th edition neoplasm staging system (tumor staging)"
 * performer = Reference(us-core-practitioner-owen-oncologist)
+* category = ObsCat#imaging "Imaging"
 
 // 21-Gene Assay
 

diff --git a/input/fsh/EX_ExtendedExample_Pediatric.fsh b/input/fsh/EX_ExtendedExample_Pediatric.fsh
@@ -168,6 +168,7 @@ Description: "Extended pediatric example: example showing Lansky performance sta
 * valueInteger = 80
 * interpretation = NCIT#C69424 "Lansky Performance Status 80"
 * method = SCT#5880005 "Physical examination procedure (procedure)"
+* category = ObsCat#survy "Survey"
 
 Instance: cancer-related-medication-request-cyclophosphamide-brian-l
 InstanceOf: CancerRelatedMedicationRequest
@@ -373,6 +374,7 @@ Description: "Extended pediatric example: body surface area"
 * performer = Reference(us-core-practitioner-owen-oncologist)
 * valueQuantity = 0.59 'm2' "square meter"
 
+/*
 Instance: all-risk-assessment-standard-brian-l
 InstanceOf: ALLRiskAssessment
 Description: "Extended pediatric example: ALL risk assessment standard"
@@ -382,6 +384,6 @@ Description: "Extended pediatric example: ALL risk assessment standard"
 * focus = Reference(primary-cancer-condition-brian-l)
 * effectiveDateTime = "2021-02-08"
 * performer = Reference(us-core-practitioner-owen-oncologist)
-
+*/
 
 
diff --git a/input/fsh/EX_Staging_Other.fsh b/input/fsh/EX_Staging_Other.fsh
@@ -18,6 +18,7 @@ RuleSet: StagingInstanceRuleSet
 
 //-------------------------------------------------
 
+/*
 Instance: binet-stage-group-B
 InstanceOf: CLLBinetStage
 Description: "Example of Binet staging for CLL."
@@ -116,3 +117,5 @@ InstanceOf: RhabdomyosarcomaClinicalGroupStage
 Description: "Example of Rhabdomyosarcoma Clinical Group Stage for rhabdomyosarcoma staging."
 * insert StagingInstanceRuleSet
 * valueCodeableConcept = SCT#405957007 "Intergroup rhabdomyosarcoma study post-surgical clinical group IA: localized tumor, confined to site of origin, completely resected (finding)"
+
+*/
diff --git a/input/fsh/SD_ComorbidCondition.fsh b/input/fsh/SD_ComorbidCondition.fsh
@@ -1,5 +1,5 @@
 Profile: Comorbidities
-Parent: Observation
+Parent: USCoreObservationSimple
 Id: mcode-comorbidities
 Title: "Comorbidities Profile"
 Description: "General structure for capturing comorbid conditions with respect to a primary ('index') condition. The user can use this profile in three ways: (1) free-form, listing any conditions they wish to highlight as significant comorbidities, (2) following a formal paradigm such as the Charlson Comorbidity Index or the NCI Comorbidity Index, or (3) use disease categories defined for registry reporting purposes, such as those defined by Center for International Blood and Marrow Transplant Research (CIBMTR)."

diff --git a/input/fsh/SD_Genomics.fsh b/input/fsh/SD_Genomics.fsh
@@ -81,7 +81,7 @@ Description: "The result of a tumor marker test. Tumor marker tests are generall
 * extension[relatedCondition] ^definition = "Associates the tumor marker test with a condition, if one exists. Condition can be given by a reference or a code. In the case of a screening test such as prostate-specific antigen (PSA), there may be no existing condition to reference."
 
 Profile: HumanSpecimen
-Parent: Specimen
+Parent: USCoreSpecimen
 Id: mcode-human-specimen
 Title:  "Human Specimen Profile"
 Description:  "A specimen taken from a Patient for the purpose of oncology-related testing. The profile includes extensions to specify a more precise body site and an identifier of source body structure at that site (for example, a tumor identifier)."

diff --git a/input/fsh/SD_Histology.fsh b/input/fsh/SD_Histology.fsh
@@ -1,5 +1,5 @@
 Profile: TumorMorphology
-Parent: Observation
+Parent: USCoreObservationSimple
 Id: mcode-tumor-morphology
 Title: "Tumor Morphology Report"
 Description: "Tumor morphology can include information on the type of cell (type), the malignant potential of the tumor (behavior), and the degree of differentiation (grade). For some cancers, the type and behavior are described in the ICD-O-3 code."
@@ -42,7 +42,7 @@ Profile: HistologicGrade
 Parent: USCoreObservationLab
 Id: mcode-histologic-grade
 Title: "Histologic Grade"
-Description: "Histologic grade determined from examination of tumor sample."
+Description: "Histologic grade determined from examination of tumor sample. The grade system should be captured using the method data element."
 * ^extension[FMM].valueInteger = 4
 * specimen only Reference(HumanSpecimen)
 * specimen 0..1 MS  // is not MS in US Core 4.0.0 and 5.0.1 

diff --git a/input/fsh/SD_HistoryOfMetastaticCancer.fsh b/input/fsh/SD_HistoryOfMetastaticCancer.fsh
@@ -1,14 +1,15 @@
 // This profile requires an exception from the CGP WG for use of Observation
 // In USCore STU6, it could be based on the SimpleObservation profile, but that does not exist in STU5
 Profile: HistoryOfMetastaticCancer
-Parent: Observation 
+Parent: USCoreObservationSimple
 Id: mcode-history-of-metastatic-cancer
 Title: "History of Metastatic Cancer"
 Description: "Records the existence of a past episode of metastatic cancer, for the purpose of long term management and tracking."
 * code from HistoryOfMetastaticMalignantNeoplasmVS (extensible)
 * value[x] only boolean // If false indicates no history of metastatic cancer
 * value[x] 0..1 MS ?!  // modifies meaning of the observation
 * value[x] ^isModifierReason = "When value is false, the resource semantics are reversed and the resource represents an assertion of NO history of metastatic cancer (either absolutely, or of the type indicated by Observation.code)"
+* extension contains RelatedCondition named relatedCondition 0..*
 // Cannot have a default value; Rule sdf-21: 'Default values can only be specified on specializations' 
 //* value[x] ^defaultValueBoolean = true   // If absent, value is true.  
 

diff --git a/input/fsh/SD_PerformanceStatus.fsh b/input/fsh/SD_PerformanceStatus.fsh
@@ -15,7 +15,7 @@ RuleSet: PerformanceStatusCommonRules
 * status and code and subject and effective[x] and value[x] and interpretation MS
 
 Profile:    KarnofskyPerformanceStatus
-Parent:     USCoreClinicalTest
+Parent:     USCoreClinicalResult
 Id: mcode-karnofsky-performance-status
 Title:      "Karnofsky Performance Status Profile"
 Description:    "The Karnofsky Performance Status (KPS) is a tool used to measure a patient's functional status. It can be used to compare the effectiveness of different therapies and to help assess the prognosis of certain patients, such as those with certain cancers. The KPS score ranges from 0 to 100 in intervals of 10. Higher scores are associated with better functional status, with 100 representing no symptoms or evidence of disease, and 0 representing death."
@@ -26,7 +26,7 @@ Description:    "The Karnofsky Performance Status (KPS) is a tool used to measur
 
 
 Profile:    ECOGPerformanceStatus
-Parent:     USCoreClinicalTest
+Parent:     USCoreClinicalResult
 Id: mcode-ecog-performance-status
 Title:      "ECOG Performance Status Profile"
 Description:    "The Eastern Cooperative Oncology Group (ECOG) Performance Status represents the patient's functional status and is used to determine their ability to tolerate therapies in serious illness, specifically for chemotherapy. (Definition from: [LOINC](https://loinc.org/89262-0/))"
@@ -37,7 +37,7 @@ Description:    "The Eastern Cooperative Oncology Group (ECOG) Performance Statu
 
 
 Profile: LanskyPlayPerformanceStatus
-Parent:  USCoreClinicalTest
+Parent:  USCoreClinicalResult
 Id: mcode-lansky-play-performance-status
 Title:  "Lansky Play Performance Status Profile"
 Description:  "The Lansky Play-Performance Status for children is a parent-rated instrument which records usual play activity as the index of performance. It is similar to the Karnofsky Performance Scale for adults (Definition from: [NCI Thesaurus](https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C38144&ns=ncit))."
@@ -49,7 +49,7 @@ Description:  "The Lansky Play-Performance Status for children is a parent-rated
 
 Profile: DeauvilleScale
 Id: mcode-deauville-scale
-Parent: USCoreObservationImaging
+Parent: USCoreClinicalResult
 Title: "Deauville Scale Profile"
 Description: "Profile for Deauville Scale. A 5 point scale devised to assess the response to treatment of Hodgkin and aggressive Non-Hodgkin lymphoma."
 * code = SCT#708895006 "Deauville five point scale (assessment scale)"