cancer_pathology_data_sharing_test_kit 0.9.0

data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/exchange_bundle/us_pathology_exchange_bundle/exchange_bundle_validation_test.rb

@@ -0,0 +1,56 @@
+# frozen_string_literal: true
+
+require_relative '../../../bundle_parse'
+require_relative '../../../validation_test'
+
+module CancerPathologyDataSharingTestKit
+  class ContentBundleValidationTest < Inferno::Test
+    include CancerPathologyDataSharingTestKit::ValidationTest
+    include CancerPathologyDataSharingTestKit::BundleParse
+    title 'Provided Bundle resources conform to the US Pathology Exchange Bundle Profile'
+    id :cpds_exchange_bundle_validation_test
+
+    description %(
+        Verify that all the generated report(s) are a conformant
+        [Pathology Exchange Bundle](http://hl7.org/fhir/us/cancer-reporting/StructureDefinition/us-pathology-exchange-bundle.html).
+      )
+
+    def resource_type
+      'Bundle'
+    end
+
+    def add_to_scratch(bundles_array)
+      scratch[:cpds_resources] ||= {}
+      scratch[:cpds_exchange_bundles] ||= []
+      bundles_array.each do |report|
+        bundle = FHIR.from_contents(report.to_json)
+        assert_resource_type('Bundle', resource: bundle)
+        bundle_id = bundle.id
+        scratch[:cpds_exchange_bundles] << bundle
+        scratch[:cpds_resources][bundle_id] = parse_bundle(bundle)
+      end
+    end
+
+    run do
+      # Put reports into array to process
+      bundles_array = JSON.parse("[#{reports}]")
+      add_to_scratch(bundles_array)
+
+      invalid_bundles = []
+      profile_with_version = 'http://hl7.org/fhir/us/cancer-reporting/StructureDefinition/us-pathology-exchange-bundle|1.0.1'
+      bundles_array.each do |bundle|
+        fhir_bundle = FHIR.from_contents(bundle.to_json)
+        invalid_bundles << fhir_bundle.id unless resource_is_valid?(resource: fhir_bundle, profile_url: profile_with_version)
+      end
+
+      # filter errors related to entry resources and Bundle slices - these are handled elsewhere
+      messages.reject! { |message| /Bundle\.entry\[\d+\]\.resource/.match?(message[:message]) }
+      messages.reject! do |message|
+        /Bundle: Slice 'Bundle\.entry:[a-zA-Z]+': a matching slice is required/.match?(message[:message])
+      end
+
+      errors_found = messages.any? { |message| message[:type] == 'error' }
+      assert !errors_found, "Bundle(s) #{invalid_bundles.join(', ')} do not conform to the profile #{profile_with_version}"
+    end
+  end
+end

data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/exchange_bundle/us_pathology_exchange_bundle/metadata.yml

@@ -0,0 +1,78 @@
+---
+:name: us_pathology_exchange_bundle
+:class_name: UsPathologyExchangeBundleSequence
+:version: v1.0.1
+:reformatted_version: v101
+:resource: Bundle
+:profile_url: http://hl7.org/fhir/us/cancer-reporting/StructureDefinition/us-pathology-exchange-bundle
+:profile_name: US Pathology Exchange Bundle
+:profile_version: 1.0.1
+:title: Bundle US Pathology Exchange
+:short_description: Verify support for the server capabilities required by the US
+  Pathology Exchange Bundle.
+:must_supports:
+  :extensions: []
+  :slices:
+  - :slice_id: Bundle.entry:us_core_patient
+    :slice_name: us_core_patient
+    :path: entry
+    :discriminator:
+      :type: type
+      :code: Patient
+  - :slice_id: Bundle.entry:us_core_patient
+    :slice_name: us_core_patient
+    :path: entry
+    :discriminator:
+      :type: type
+      :code: Patient
+  - :slice_id: Bundle.entry:us_core_encounter
+    :slice_name: us_core_encounter
+    :path: entry
+    :discriminator:
+      :type: type
+      :code: Encounter
+  - :slice_id: Bundle.entry:diagnosticreport
+    :slice_name: diagnosticreport
+    :path: entry
+    :discriminator:
+      :type: type
+      :code: DiagnosticReport
+  - :slice_id: Bundle.entry:specimen
+    :slice_name: specimen
+    :path: entry
+    :discriminator:
+      :type: type
+      :code: Specimen
+  - :slice_id: Bundle.entry:service-request
+    :slice_name: service-request
+    :path: entry
+    :discriminator:
+      :type: type
+      :code: ServiceRequest
+  - :slice_id: Bundle.entry:pathology-related-practitioner
+    :slice_name: pathology-related-practitioner
+    :path: entry
+    :discriminator:
+      :type: type
+      :code: Practitioner
+  :elements:
+  - :path: type
+    :fixed_value: transaction
+  - :path: timestamp
+  - :path: entry
+  - :path: entry:us_core_patient.resource
+  - :path: entry:us_core_encounter.resource
+  - :path: entry:service-request.resource
+  - :path: entry:pathology-related-practitioner.resource
+:mandatory_elements:
+- Bundle.type
+- Bundle.link.relation
+- Bundle.link.url
+- Bundle.entry
+- Bundle.entry.request.method
+- Bundle.entry.request.url
+- Bundle.entry.response.status
+- Bundle.entry.resource
+:tests: []
+:id: v101_us_pathology_exchange_bundle
+:file_name: us_pathology_exchange_bundle_group.rb

data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/exchange_bundle/us_pathology_exchange_bundle/us_pathology_exchange_bundle_must_support_test.rb

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+require_relative '../../../must_support_test'
+require_relative '../../../group_metadata'
+
+module CancerPathologyDataSharingTestKit
+  module V101
+    class UsPathologyExchangeBundleMustSupportTest < Inferno::Test
+      include CancerPathologyDataSharingTestKit::MustSupportTest
+
+      title 'All must support elements are provided in the US Pathology Exchange Bundle resources'
+      description %(
+        Report generators SHALL be capable of populating all must support data elements
+        defined in the [US Pathology ExchangeBundle profile](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)
+        and profiles it references. This test will look through the Bundle resources
+        found in the provided report Bundles for the following must support elements:
+
+        * Bundle.entry
+        * Bundle.entry:pathology-related-practitioner.resource
+        * Bundle.entry:service-request.resource
+        * Bundle.entry:us_core_encounter.resource
+        * Bundle.entry:us_core_patient.resource
+        * Bundle.timestamp
+        * Bundle.type
+      )
+
+      id :cpds_v101_us_pathology_exchange_bundle_must_support_test
+
+      def resource_type
+        'Bundle'
+      end
+
+      def self.metadata
+        @metadata ||= GroupMetadata.new(YAML.load_file(File.join(__dir__, 'metadata.yml'), aliases: true))
+      end
+
+      run do
+        all_resources = scratch[:cpds_exchange_bundles]
+        perform_must_support_test(all_resources&.flatten)
+      end
+    end
+  end
+end

data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/exchange_bundle_group.rb

@@ -0,0 +1,104 @@
+require_relative 'exchange_bundle/us_pathology_exchange_bundle/exchange_bundle_validation_test'
+require_relative 'exchange_bundle/us_pathology_diagnostic_report/diagnostic_report_validation_test'
+require_relative 'exchange_bundle/encounter/encounter_validation_test'
+require_relative 'exchange_bundle/practitioner_role/practitioner_role_validation_test'
+require_relative 'exchange_bundle/patient/patient_validation_test'
+require_relative 'exchange_bundle/service_request/service_request_validation_test'
+require_relative 'exchange_bundle/specimen/specimen_validation_test'
+
+require_relative 'exchange_bundle/us_pathology_exchange_bundle/us_pathology_exchange_bundle_must_support_test'
+require_relative 'exchange_bundle/patient/patient_must_support_test'
+require_relative 'exchange_bundle/encounter/encounter_must_support_test'
+require_relative 'exchange_bundle/us_pathology_diagnostic_report/us_pathology_diagnostic_report_must_support_test'
+require_relative 'exchange_bundle/specimen/specimen_must_support_test'
+require_relative 'exchange_bundle/service_request/service_request_must_support_test'
+require_relative 'exchange_bundle/practitioner_role/practitioner_role_must_support_test'
+
+require_relative 'data_absent_group'
+
+module CancerPathologyDataSharingTestKit
+  class ExchangeBundleGroup < Inferno::TestGroup
+    title 'Exchange Bundle Group'
+    id :cpds_exchange_bundle_group
+    description %(
+      # Background
+
+      Theses tests verify that the system under test can generate conformant and complete cancer pathology reports
+      following the requirements in the [Cancer Pathology Exchange Bundle profile](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html).
+      The tester will provide a list of Bundles generated by the system under test in the **Cancer Reports** input.
+      Inferno will verify the conformance of each report and that the set of reports contains examples
+      of all entry slices and each element that the Bundle profile and referenced profiles indicate must be supported.
+
+      # Testing Methodology
+      The provided Bundles are parsed and the individual resources within them are separated out
+      and assigned a target profile based on their resource type.
+
+      ## Profile Validation
+      Each resource extracted from the bundles is expected to conform to
+      its target profile. Each element in each resource is checked against
+      teminology binding and cardinality requirements by the HL7 FHIR validator.
+
+      While the [Cancer Pathology Exchange Bundle profile](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)
+      slices entries by profile, Inferno checks that any instances of the profiled resource type
+      conform to the indicated profile and there are not more instances of the profiled resource type than allowed
+      by the slice cardinality. Specifically, each report must contain:
+      - Exactly one Patient, which must conform to the [US Core Patient profile](http://hl7.org/fhir/us/core/STU5.0.1/StructureDefinition-us-core-patient.html).
+      - At most one Encounter, which, if present, must conform to the [US Core Encounter profile](http://hl7.org/fhir/us/core/STU5.0.1/StructureDefinition-us-core-encounter.html).
+      - Exactly one DiagnosticReport, which must conform to the [US Pathology Diagnostic Report profile](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-diagnostic-report.html).
+      - One or more Specimens, each of which must conform to the [US Pathology Specimen profile](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-specimen.html).
+
+      Additionally, each report may include:
+      - Any number of ServiceRequests, each of which must conform to the [US Pathology Service Requests profile](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-service-request.html).
+      - Any number of PractitionRoles, each of which must conform to the [US Pathology Related Practitioner Roles profile](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-related-practitioner-role.html).
+
+      ## Must Support
+      Must Support tests in this group check that each element of the target profile marked
+      as "must support" is observed at least once across instances assigned to that profile.
+      If one or more elements are not observed, the test will fail.
+    )
+    run_as_group
+
+    group do
+      title 'Report'
+      test from: :cpds_exchange_bundle_validation_test
+      test from: :cpds_v101_us_pathology_exchange_bundle_must_support_test
+    end
+
+    group do
+      title 'Patient'
+      test from: :cpds_patient_validation_test
+      test from: :cpds_v101_us_core_v311_patient_must_support_test
+    end
+
+    group do
+      title 'Encounter'
+      test from: :cpds_encounter_validation_test
+      test from: :cpds_v101_us_core_v311_encounter_must_support_test
+    end
+
+    group do
+      title 'Diagnostic Report'
+      test from: :cpds_diagnostic_report_validation_test
+      test from: :cpds_v101_us_pathology_diagnostic_report_must_support_test
+    end
+
+    group do
+      title 'Specimen'
+      test from: :cpds_specimen_validation_test
+      test from: :cpds_v101_specimen_must_support_test
+    end
+
+    group do
+      title 'Service Request'
+      test from: :cpds_service_request_validation_test
+      test from: :cpds_v101_service_request_must_support_test
+    end
+
+    group do
+      title 'Practitioner Role'
+      test from: :cpds_practitioner_role_validation_test
+      test from: :cpds_v101_practitioner_role_must_support_test
+    end
+    group from: :cpds_data_absent_reason
+  end
+end

data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite.rb

@@ -0,0 +1,73 @@
+require 'inferno/dsl/oauth_credentials'
+require_relative 'urls'
+require_relative 'version'
+require_relative 'report_generation_suite/exchange_bundle_group'
+
+module CancerPathologyDataSharingTestKit
+  class ReportGenerationSuite < Inferno::TestSuite
+    include URLs
+    id :cpds_report_generation
+    title 'Cancer Pathology Data Sharing Report Generation Test Suite'
+    short_title 'CPDS Report Generation Test Suite'
+    description File.read(File.join(__dir__, 'docs', 'report_generation_suite_description.md'))
+    links [
+      {
+        label: 'Report Issue',
+        url: 'https://github.com/inferno-framework/cancer-pathology-data-sharing-test-kit/issues/'
+      },
+      {
+        label: 'Open Source',
+        url: 'https://github.com/inferno-framework/cancer-pathology-data-sharing-test-kit/'
+      },
+      {
+        label: 'Download',
+        url: 'https://github.com/inferno-framework/cancer-pathology-data-sharing-test-kit/releases'
+      },
+      {
+        label: 'Implementation Guide',
+        url: 'https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/'
+      }
+    ]
+
+    GENERAL_MESSAGE_FILTERS = [
+      %r{Sub-extension url 'introspect' is not defined by the Extension http://fhir-registry\.smarthealthit\.org/StructureDefinition/oauth-uris},
+      %r{Sub-extension url 'revoke' is not defined by the Extension http://fhir-registry\.smarthealthit\.org/StructureDefinition/oauth-uris},
+      /Observation\.effective\.ofType\(Period\): .*vs-1:/, # Invalid invariant in FHIR v4.0.1
+      /Observation\.effective\.ofType\(Period\): .*us-core-1:/, # Invalid invariant in US Core v3.1.1
+      /Provenance.agent\[\d*\]: Constraint failed: provenance-1/, # Invalid invariant in US Core v5.0.1
+      %r{Unknown Code System 'http://hl7.org/fhir/us/core/CodeSystem/us-core-tags'}, # Validator has an issue with this US Core 5 code system in US Core 6 resource # rubocop:disable Layout/LineLength
+      %r{URL value 'http://hl7.org/fhir/us/core/CodeSystem/us-core-tags' does not resolve}, # Validator has an issue with this US Core 5 code system in US Core 6 resource # rubocop:disable Layout/LineLength
+      /\A\S+: \S+: URL value '.*' does not resolve/,
+      %r{Observation.component\[\d+\].value.ofType\(Quantity\): The code provided \(http://unitsofmeasure.org#L/min\) was not found in the value set 'Vital Signs Units'} # Known issue with the Pulse Oximetry Profile # rubocop:disable Layout/LineLength
+    ].freeze
+    VALIDATION_MESSAGE_FILTERS = GENERAL_MESSAGE_FILTERS
+
+    fhir_resource_validator do
+      igs 'hl7.fhir.us.cancer-reporting#1.0.1', 'hl7.fhir.us.core#5.0.1'
+      message_filters = VALIDATION_MESSAGE_FILTERS
+
+      exclude_message do |message|
+        message_filters.any? { |filter| filter.match? message.message }
+      end
+
+      perform_additional_validation do |resource, _profile_url|
+        ProvenanceValidator.validate(resource) if resource.instance_of?(FHIR::Provenance)
+      end
+    end
+
+    resume_test_route :get, RESUME_PASS_PATH do |request|
+      request.query_parameters['token']
+    end
+    resume_test_route :get, RESUME_FAIL_PATH, result: 'fail' do |request|
+      request.query_parameters['token']
+    end
+
+    input :reports,
+          title: 'Cancer Reports',
+          description: 'A comma-Separated list of one or more FHIR Pathology Cancer Exchange Bundles ' \
+                       'in JSON format generated by the system under test.',
+          type: 'textarea'
+
+    group from: :cpds_exchange_bundle_group
+  end
+end

data/lib/cancer_pathology_data_sharing_test_kit/urls.rb

@@ -0,0 +1,25 @@
+# frozen_string_literal: true
+
+module CancerPathologyDataSharingTestKit
+  RESUME_PASS_PATH = '/resume_pass'
+  RESUME_FAIL_PATH = '/resume_fail'
+
+  # URLs
+  module URLs
+    def base_url
+      @base_url ||= "#{Inferno::Application['base_url']}/custom/#{suite_id}"
+    end
+
+    def resume_pass_url
+      @resume_pass_url ||= base_url + RESUME_PASS_PATH
+    end
+
+    def resume_fail_url
+      @resume_fail_url ||= base_url + RESUME_FAIL_PATH
+    end
+
+    def suite_id
+      self.class.suite.id
+    end
+  end
+end

data/lib/cancer_pathology_data_sharing_test_kit/us_core_data_access_suite/us_core_group.rb

@@ -0,0 +1,72 @@
+require 'us_core_test_kit'
+
+module CancerPathologyDataSharingTestKit
+  class USCoreDataAccessGroup < Inferno::TestGroup
+    id :cpds_us_core_data_access
+    title 'US Core FHIR API Tests'
+    short_description 'Verify that cancer patient data are available via US Core API.'
+    description %(
+      During these tests, Inferno will simulate a FHIR client and verify that it can use the target systems's
+      FHIR APIs to access [US Core v5](http://hl7.org/fhir/us/core/STU3.1.1/index.html) data.
+    )
+    input :url,
+          title: 'FHIR Endpoint',
+          description: 'URL of the FHIR endpoint'
+
+    input :smart_credentials,
+          title: 'OAuth Credentials',
+          type: :auth_info,
+          optional: true
+
+    fhir_client do
+      url :url
+      auth_info :smart_credentials
+    end
+
+    group from: :us_core_v501_capability_statement
+
+    group from: :us_core_v501_patient
+    group from: :us_core_v501_allergy_intolerance
+    group from: :us_core_v501_care_plan
+    group from: :us_core_v501_care_team
+    group from: :us_core_v501_condition_encounter_diagnosis
+    group from: :us_core_v501_condition_problems_health_concerns
+    group from: :us_core_v501_device
+    group from: :us_core_v501_diagnostic_report_note
+    group from: :us_core_v501_diagnostic_report_lab
+    group from: :us_core_v501_document_reference
+    group from: :us_core_v501_encounter
+    group from: :us_core_v501_goal
+    group from: :us_core_v501_immunization
+    group from: :us_core_v501_medication_request
+    group from: :us_core_v501_observation_lab
+    group from: :us_core_v501_observation_sdoh_assessment
+    group from: :us_core_v501_respiratory_rate
+    group from: :us_core_v501_observation_social_history
+    group from: :us_core_v501_heart_rate
+    group from: :us_core_v501_body_temperature
+    group from: :us_core_v501_pediatric_weight_for_height
+    group from: :us_core_v501_pulse_oximetry
+    group from: :us_core_v501_smokingstatus
+    group from: :us_core_v501_observation_sexual_orientation
+    group from: :us_core_v501_head_circumference
+    group from: :us_core_v501_body_height
+    group from: :us_core_v501_bmi
+    group from: :us_core_v501_blood_pressure
+    group from: :us_core_v501_observation_imaging
+    group from: :us_core_v501_observation_clinical_test
+    group from: :us_core_v501_pediatric_bmi_for_age
+    group from: :us_core_v501_head_circumference_percentile
+    group from: :us_core_v501_body_weight
+    group from: :us_core_v501_procedure
+    group from: :us_core_v501_questionnaire_response
+    group from: :us_core_v501_service_request
+    group from: :us_core_v501_organization
+    group from: :us_core_v501_practitioner
+    group from: :us_core_v501_practitioner_role
+    group from: :us_core_v501_provenance
+    group from: :us_core_v501_related_person
+    group from: :us_core_v400_clinical_notes_guidance
+    group from: :us_core_311_data_absent_reason
+  end
+end

data/lib/cancer_pathology_data_sharing_test_kit/us_core_data_access_suite.rb

@@ -0,0 +1,58 @@
+require_relative 'us_core_data_access_suite/us_core_group'
+module CancerPathologyDataSharingTestKit
+  class USCoreDataAccessSuite < Inferno::TestSuite
+    id :cpds_data_access
+    title 'Cancer Pathology Data Sharing Data Access Test Suite'
+    short_title 'CPDS Data Access Suite'
+    description File.read(File.join(__dir__, 'docs', 'data_access_suite_description.md'))
+    links [
+      {
+        label: 'Report Issue',
+        url: 'https://github.com/inferno-framework/cancer-pathology-data-sharing-test-kit/issues/'
+      },
+      {
+        label: 'Open Source',
+        url: 'https://github.com/inferno-framework/cancer-pathology-data-sharing-test-kit/'
+      },
+      {
+        label: 'Download',
+        url: 'https://github.com/inferno-framework/cancer-pathology-data-sharing-test-kit/releases'
+      },
+      {
+        label: 'Implementation Guide',
+        url: 'https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/'
+      }
+    ]
+
+    GENERAL_MESSAGE_FILTERS = [
+      %r{Sub-extension url 'introspect' is not defined by the Extension http://fhir-registry\.smarthealthit\.org/StructureDefinition/oauth-uris},
+      %r{Sub-extension url 'revoke' is not defined by the Extension http://fhir-registry\.smarthealthit\.org/StructureDefinition/oauth-uris},
+      /Observation\.effective\.ofType\(Period\): .*vs-1:/, # Invalid invariant in FHIR v4.0.1
+      /Observation\.effective\.ofType\(Period\): .*us-core-1:/, # Invalid invariant in US Core v3.1.1
+      /Provenance.agent\[\d*\]: Constraint failed: provenance-1/, # Invalid invariant in US Core v5.0.1
+      %r{Unknown Code System 'http://hl7.org/fhir/us/core/CodeSystem/us-core-tags'}, # Validator has an issue with this US Core 5 code system in US Core 6 resource # rubocop:disable Layout/LineLength
+      %r{URL value 'http://hl7.org/fhir/us/core/CodeSystem/us-core-tags' does not resolve}, # Validator has an issue with this US Core 5 code system in US Core 6 resource # rubocop:disable Layout/LineLength
+      /\A\S+: \S+: URL value '.*' does not resolve/,
+      %r{Observation.component\[\d+\].value.ofType\(Quantity\): The code provided \(http://unitsofmeasure.org#L/min\) was not found in the value set 'Vital Signs Units'} # Known issue with the Pulse Oximetry Profile # rubocop:disable Layout/LineLength
+    ].freeze
+
+    VERSION_SPECIFIC_MESSAGE_FILTERS = [].freeze
+
+    VALIDATION_MESSAGE_FILTERS = GENERAL_MESSAGE_FILTERS + VERSION_SPECIFIC_MESSAGE_FILTERS
+
+    fhir_resource_validator do
+      igs('hl7.fhir.us.core#5.0.1')
+      message_filters = VALIDATION_MESSAGE_FILTERS
+
+      exclude_message do |message|
+        message_filters.any? { |filter| filter.match? message.message }
+      end
+
+      perform_additional_validation do |resource, _profile_url|
+        USCoreTestKit::ProvenanceValidator.validate(resource) if resource.instance_of?(FHIR::Provenance)
+      end
+    end
+
+    group from: :cpds_us_core_data_access
+  end
+end

data/lib/cancer_pathology_data_sharing_test_kit/validation_test.rb

@@ -0,0 +1,96 @@
+module CancerPathologyDataSharingTestKit
+  module ValidationTest
+    DAR_CODE_SYSTEM_URL = 'http://terminology.hl7.org/CodeSystem/data-absent-reason'.freeze
+    DAR_EXTENSION_URL = 'http://hl7.org/fhir/StructureDefinition/data-absent-reason'.freeze
+
+    CARDINALITY_RESTRICTIONS = {
+      'exactly_one' =>
+        ['==', 1,
+         'There must be exactly one (1) %<resource_type>s resource per bundle. Bundle `%<bundle_id>s` has %<resources_length>s resource(s)'],
+      'no_more_than_one' =>
+        ['<=', 1,
+         'There must be no more than one (1) %<resource_type>s resource per bundle. Bundle `%<bundle_id>s` has %<resources_length>s resource(s)'],
+      'at_least_one' =>
+        ['>=', 1,
+         'There must be at least one (1) %<resource_type>s resource per bundle. Bundle `%<bundle_id>s` has %<resources_length>s resource(s)']
+    }.freeze
+
+    def perform_strict_validation_test(the_resource_type = resource_type, # rubocop:disable Metrics/CyclomaticComplexity,Style/OptionalArguments
+                                       bundle_id,
+                                       resources,
+                                       profile_url,
+                                       profile_version,
+                                       skip_if_empty: true,
+                                       restriction: nil)
+      if !restriction.nil? && !resources.length.public_send(CARDINALITY_RESTRICTIONS[restriction][0], CARDINALITY_RESTRICTIONS[restriction][1])
+        messages << {
+          type: 'error',
+          message: format(CARDINALITY_RESTRICTIONS[restriction][2], resource_type: resource_type, bundle_id: bundle_id,
+                                                                    resources_length: resources.length)
+        }
+        return true
+      end
+
+      skip_if skip_if_empty && resources.blank?,
+              "No #{the_resource_type} resources in bundle `#{bundle_id}` were provided so the #{profile_url} profile does not apply"
+
+      if resources.blank?
+        messages << {
+          type: 'info',
+          message: "No #{the_resource_type} resources in bundle `#{bundle_id}` were provided so the #{profile_url} profile does not apply"
+        }
+        return false
+      end
+
+      not_valid = false
+      profile_with_version = "#{profile_url}|#{profile_version}"
+      resources.each do |resource|
+        not_valid == true unless resource_is_valid?(resource: resource, profile_url: profile_with_version)
+        check_for_dar(resource)
+      end
+
+      if not_valid
+        messages << {
+          type: 'error',
+          message: "At least one of the #{the_resource_type} resource(s) in bundle `#{bundle_id}` does not " \
+                   "conform to the profile #{profile_with_version}"
+        }
+      end
+
+      not_valid
+    end
+
+    def check_for_dar(resource)
+      unless scratch[:dar_code_found]
+        resource.each_element do |element, _meta, _path|
+          next unless element.is_a?(FHIR::Coding)
+
+          check_for_dar_code(element)
+        end
+      end
+
+      return if scratch[:dar_extension_found]
+
+      check_for_dar_extension(resource)
+    end
+
+    def check_for_dar_code(coding)
+      return unless coding.code == 'unknown' && coding.system == DAR_CODE_SYSTEM_URL
+
+      scratch[:dar_code_found] = true
+      output dar_code_found: 'true'
+    end
+
+    def check_for_dar_extension(resource)
+      return unless resource.source_contents&.include? DAR_EXTENSION_URL
+
+      scratch[:dar_extension_found] = true
+      output dar_extension_found: 'true'
+    end
+
+    def check_for_errors(invalid_bundles)
+      assert invalid_bundles.empty?, "Issues found in Bundle(s): #{invalid_bundles.join(', ')}"
+      assert messages.none? { |message| message[:type] == 'error' }, 'Non-conformant instances detected.'
+    end
+  end
+end

data/lib/cancer_pathology_data_sharing_test_kit/version.rb

@@ -0,0 +1,4 @@
+module CancerPathologyDataSharingTestKit
+  VERSION = '0.9.0'.freeze
+  LAST_UPDATED = '2025-05-07'.freeze # TODO: update next release
+end

data/lib/cancer_pathology_data_sharing_test_kit.rb

@@ -0,0 +1,3 @@
+require_relative 'cancer_pathology_data_sharing_test_kit/metadata'
+require_relative 'cancer_pathology_data_sharing_test_kit/us_core_data_access_suite'
+require_relative 'cancer_pathology_data_sharing_test_kit/report_generation_suite'