cancer_pathology_data_sharing_test_kit 0.10.0 → 0.10.1
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- checksums.yaml +4 -4
- data/lib/cancer_pathology_data_sharing_test_kit/docs/data_access_suite_description.md +8 -10
- data/lib/cancer_pathology_data_sharing_test_kit/docs/report_generation_suite_description.md +8 -8
- data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/data_absent/data_absent_reason_code_system.rb +20 -5
- data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/data_absent/data_absent_reason_extension.rb +26 -4
- data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/data_absent/sending_hide_missing.rb +20 -3
- data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/data_absent_group.rb +27 -10
- data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/exchange_bundle_group.rb +62 -28
- data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite.rb +8 -0
- data/lib/cancer_pathology_data_sharing_test_kit/requirements/cancer_pathology_data_sharing_test_kit_requirements.csv +34 -0
- data/lib/cancer_pathology_data_sharing_test_kit/requirements/generated/cpds_data_access_requirements_coverage.csv +11 -0
- data/lib/cancer_pathology_data_sharing_test_kit/requirements/generated/cpds_report_generation_requirements_coverage.csv +16 -0
- data/lib/cancer_pathology_data_sharing_test_kit/requirements/hl7.fhir.us.cancer-reporting_1.0.1_requirements.xlsx +0 -0
- data/lib/cancer_pathology_data_sharing_test_kit/us_core_data_access_suite.rb +8 -0
- data/lib/cancer_pathology_data_sharing_test_kit/version.rb +2 -2
- metadata +6 -2
checksums.yaml
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SHA256:
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metadata.gz:
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data.tar.gz:
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metadata.gz: 0a39bb5d0c23ebd530d1a30b2cde6ba488278a9df01a92c651b7f33b062e1add
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data.tar.gz: '052906955093dd6ce6aff4a2fd3ddb9bc7c2c91d7322ef1d07751a36077a88e9'
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metadata.gz: 85a363e25bed54822a593cf60586565ac099c901f52ea5296f850ce499bc566fc4630c11dc95fb89a136a0ecd55afd2208ed737abdc189702352cb99cdde6ed4
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data.tar.gz: 3c6e10c61fdf155a25a3592ca017b2a8a48db08610136ff248c56de9ad41b365e1fe9b2ba34cf33e1bd045e684476b734754855d29d0f8db2ba4a73adda38dfe
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## Overview
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The Cancer Pathology Data Sharing (CPDS) Data Access Test Suite verifies the ability of
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clinical systems to make [US Core](http://hl7.org/fhir/us/core/STU5.0.1/)
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data accessible to other systems per the
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STU 1.0.1 version of the HL7® FHIR® [Cancer Pathology Data Sharing IG](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/).
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The Cancer Pathology Data Sharing (CPDS) Data Access Test Suite validates that clinical systems implement the required FHIR APIs for sharing cancer pathology data as specified in the STU 1.0.1 version of the [Cancer Pathology Data Sharing IG](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/). This suite ensures systems can properly expose standardized pathology data through [US Core](http://hl7.org/fhir/us/core/STU5.0.1/) APIs.
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## Scope
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The CPDS IG mandates specific API capabilities for both [Laboratory Information Systems (LIS)](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/CapabilityStatement-pathology-lab-information-system.html) and [Electronic Health Records (EHR)](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html). This test suite validates:
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- Implementation of US Core STU 5 search and read operations
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- Support for required search parameters and combinations
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- Proper population of must-support elements
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- Correct profile conformance for returned resources
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- Resolution of referenced resources
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Other capabilities that the CPDS IG requires of these systems are currently out of scope
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for this test suite, including
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so that the system under test can identify Inferno as the requestor. If the **Access Token** input is populated,
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the provided value will be placed in the HTTP `Authorization` header with the prefix `Bearer `.
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Support for Inferno to obtain bearer tokens using SMART on FHIR workflows or other auth schemes may be added
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in the future based on community feedback.
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in the future based on community feedback.
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## Overview
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The Cancer Pathology Data Sharing Report Generation Test Suite
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including laboratory information systems (LISs) & electronic health records (EHRs) to the report generation
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requirements in the STU 1.0.1 version of the HL7® FHIR®
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[Cancer Pathology Data Sharing (CPDS) IG](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/).
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The Cancer Pathology Data Sharing Report Generation Test Suite validates that clinical systems (Laboratory Information Systems and Electronic Health Records) can create pathology reports that conform to the STU 1.0.1 version of the HL7® FHIR® [Cancer Pathology Data Sharing (CPDS) IG](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/). This suite ensures systems can properly structure and encode pathology data for cancer registry reporting.
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## Scope
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This test suite
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This test suite validates the creation of standardized pathology reports for cancer registry submission. It verifies that systems can generate [Pathology Cancer Exchange Bundles](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html) that include all required components:
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- Patient demographics (US Core Patient)
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- Encounter details (US Core Encounter)
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- Diagnostic findings (US Pathology Diagnostic Report)
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- Specimen information (US Pathology Specimen)
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- Service requests and practitioner details
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The IG defines other capabilities of clinical systems that are currently out of scope for this suite, including:
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- The gathering of report content from other systems, if necessary.
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The CPDS IG refers to the MedMorph framework for submission which uses FHIR Messaging. Currently, this test suite
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does not support submission of reports using this standards-based approach and instead requires manual provision of
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the reports using Inferno inputs. Future versions may include support for FHIR Messaging or other approaches
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to submission.
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to submission.
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id :cpds_data_absent_reason_code_system
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title 'Server represents missing data with the DataAbsentReason CodeSystem'
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description %(
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For coded data elements (fields bound to value sets), the CPDS IG specifies how to handle missing data:
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Primary Approach:
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* If the value set includes an appropriate "unknown" code, that code SHALL be used
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* Example: Using SNOMED CT "unknown" code for fields bound to SNOMED CT value sets
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Alternative Approach:
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* For value sets with example, preferred, or extensible binding strengths that do not include
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an appropriate "unknown" code, servers SHALL use the "unknown" code from the
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[DataAbsentReason CodeSystem](http://hl7.org/fhir/R4/codesystem-data-absent-reason.html)
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* This ensures consistent representation of unknown values across all coded fields
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This test validates that when appropriate "unknown" codes are not available in the bound
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value sets, the system correctly uses the DataAbsentReason CodeSystem's "unknown" code
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to represent missing data in coded fields.
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Note: This is different from the DataAbsentReason Extension, which is used for non-coded
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fields. The DataAbsentReason CodeSystem is specifically for coded fields where the bound
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value set lacks an appropriate "unknown" code.
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)
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input :dar_code_found,
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title: 'Data Absent Reason CodeSystem Found',
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locked: true,
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module CancerPathologyDataSharingTestKit
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class DataAbsentReasonExtension < Inferno::Test
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id :cpds_data_absent_reason_extension
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title '
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title 'DataAbsentReason Extension Implementation for Non-Coded Fields'
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description %(
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The Cancer Pathology Data Sharing IG requires specific handling of missing data in required fields.
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For non-coded fields that are required but the data is not available, systems SHALL use the
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[DataAbsentReason Extension](http://hl7.org/fhir/StructureDefinition/data-absent-reason) to explicitly
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indicate why the data is not present.
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The extension must be used with one of these values to indicate why data is missing:
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* unknown - The value is not known and there is no expectation that it will be known
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* asked-unknown - The source was queried but does not know the value
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* temp-unknown - The value is not known at this time but is expected to be known later
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* not-asked - The source was not asked for the value
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* asked-declined - The source was asked for the value but declined to answer
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* masked - The information is available but not provided due to security, privacy, or other reasons
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* not-applicable - The field is not applicable to this concept
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* unsupported - The source system does not support this field
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* as-text - The information is available but only as text
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* error - The information is not available due to an error
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* not-performed - The task/step associated with this element was not performed
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* not-permitted - The user does not have the necessary rights to view this information
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This test validates that the system properly implements this extension pattern when representing
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missing non-coded data elements, as specified in the [CPDS Missing Data Guidance](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data).
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For coded fields (those bound to value sets), systems should instead use the appropriate "unknown" code
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from the value set rather than the DataAbsentReason extension.
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)
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input :dar_extension_found,
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title: 'Data Absent Reason Extension Found',
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locked: true,
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id :cpds_data_absent_sending_hide_missing
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title 'Sender does not send data element(s) with missing information'
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description %(
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The CPDS IG provides specific guidance for handling optional data elements (those with cardinality 0..n)
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when the information is not available. This requirement helps reduce message size and processing overhead
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while maintaining semantic clarity.
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Key Requirements:
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* When information for an optional data element is not available, the Sender SHALL NOT include
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the empty element in the resource instance
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* This applies only to elements with cardinality 0..n (optional elements)
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* For required elements (cardinality 1..n or 1..1), use the appropriate missing data pattern instead:
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* DataAbsentReason Extension for non-coded fields
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* "Unknown" codes from value sets for coded fields
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Examples:
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* DO NOT include an empty 'note' element if there are no notes
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* DO NOT include an empty 'identifier' array if there are no identifiers
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* DO NOT include null or empty string values in optional elements
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This test verifies that the system correctly omits optional elements when their data is not available,
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rather than including them with empty or null values.
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)
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run do
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identifier = SecureRandom.hex(32)
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data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/data_absent_group.rb
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module CancerPathologyDataSharingTestKit
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class DataAbsentGroup < Inferno::TestGroup
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id :cpds_data_absent_reason
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title 'Missing Data
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short_description 'Verify
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title 'Cancer Pathology Missing Data Representation'
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short_description 'Verify compliance with CPDS IG missing data requirements.'
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description %(
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The [
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The Cancer Pathology Data Sharing IG provides specific [Missing Data Guidance](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data)
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for handling required data elements that may not be available. The IG defines different approaches based on the type of field:
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For Non-Coded Fields:
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* Systems SHALL use the DataAbsentReason Extension to explicitly indicate why required data is missing
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* The extension must use standardized codes like 'unknown', 'asked-unknown', 'temp-unknown', etc.
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* This applies to string, dateTime, and other non-coded fields
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For Coded Fields (bound to ValueSets):
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* Systems SHALL use the appropriate "unknown" code from the specified value set
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* The DataAbsentReason Extension should NOT be used for these fields
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* Example: Using "unknown" SNOMED CT code for a field bound to SNOMED CT concepts
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Display Requirements:
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* Systems SHALL support the ability to hide missing data in displays
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* This helps reduce visual clutter while still maintaining the complete data
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* Display preferences should be configurable by users
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These tests validate that resources properly implement all three aspects of missing data handling:
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1. Correct use of DataAbsentReason Extension for non-coded fields
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2. Proper use of "unknown" codes from value sets for coded fields
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3. Support for configurable display of missing data
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Each resource previously tested has been analyzed for correct implementation of these missing data patterns
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as specified in the IG.
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)
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run_as_group
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data/lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/exchange_bundle_group.rb
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description %(
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# Background
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The
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of all entry slices and each element that the Bundle profile and referenced profiles indicate must be supported.
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These tests verify that the system under test can generate conformant and complete cancer pathology reports
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according to the [Cancer Pathology Data Sharing Implementation Guide](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/).
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The tests focus on validating the [Cancer Pathology Exchange Bundle profile](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)
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and all its required components.
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# Testing Methodology
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## Report Submission
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The tester provides one or more cancer pathology report bundles through the **Cancer Reports** input.
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Each bundle should represent a complete pathology report ready for submission to a cancer registry.
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## Bundle Structure Validation
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Each bundle is validated to ensure:
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* Type is set to "transaction"
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* Timestamp is present indicating when the bundle was created
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* All required entries are present with correct cardinality
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* Resources conform to their required profiles
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* References between resources are valid and resolvable
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## Required Resources
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Each cancer pathology report bundle must contain:
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* Patient Demographics (1..1)
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* Must conform to [US Core Patient](http://hl7.org/fhir/us/core/STU5.0.1/StructureDefinition-us-core-patient.html)
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* Contains essential patient identification and demographic data
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* Encounter Information (1..1)
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* Must conform to [US Core Encounter](http://hl7.org/fhir/us/core/STU5.0.1/StructureDefinition-us-core-encounter.html)
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* Documents the context of the pathology examination
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* Diagnostic Report (1..1)
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* Must conform to [US Pathology Diagnostic Report](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-diagnostic-report.html)
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* Contains the core pathology findings and interpretations
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* Specimen Details (1..*)
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* Must conform to [US Pathology Specimen](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-specimen.html)
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* Describes the specimens examined
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* Service Request (1..1)
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* Must conform to [Cancer Pathology Service Request](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-service-request.html)
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* Documents the original order/request
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* Organization Information (1..*)
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* Must conform to [US Core Organization](http://hl7.org/fhir/us/core/STU5.0.1/StructureDefinition-us-core-organization.html)
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* Identifies the facilities involved
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* Provider Information
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* Practitioners (1..*)
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* Must conform to [US Core Practitioner](http://hl7.org/fhir/us/core/STU5.0.1/StructureDefinition-us-core-practitioner.html)
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* PractitionerRoles (1..*)
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* Must conform to [US Core PractitionerRole](http://hl7.org/fhir/us/core/STU5.0.1/StructureDefinition-us-core-practitionerrole.html)
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* Identifies the healthcare providers involved and their roles
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## Profile Validation
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If one or more elements are not observed, the test will fail.
|
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For each resource type, the tests verify:
|
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* Conformance to the required profile
|
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* Presence of all required elements
|
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* Correct use of required terminologies and value sets
|
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* Valid references to other resources
|
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* Proper cardinality of elements and slices
|
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## Must Support Validation
|
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For each profile, the tests verify that all elements marked as "must support" are demonstrated
|
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at least once across the submitted reports. This ensures systems can:
|
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* Populate all required data elements
|
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* Handle all required data types and structures
|
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* Support all required workflows and use cases
|
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|
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## Missing Data Handling
|
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The tests also verify proper implementation of missing data patterns:
|
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* Use of DataAbsentReason Extension for non-coded required fields
|
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* Use of appropriate "unknown" codes for coded fields
|
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* Proper handling of optional missing elements
|
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)
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run_as_group
|
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@@ -29,6 +29,14 @@ module CancerPathologyDataSharingTestKit
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}
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requirement_sets(
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{
|
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identifier: 'hl7.fhir.us.cancer-reporting_1.0.1',
|
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title: 'Cancer Pathology Data Sharing IG STU 1.0.1',
|
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actor: 'Report Creator'
|
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}
|
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)
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GENERAL_MESSAGE_FILTERS = [
|
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%r{Sub-extension url 'introspect' is not defined by the Extension http://fhir-registry\.smarthealthit\.org/StructureDefinition/oauth-uris},
|
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%r{Sub-extension url 'revoke' is not defined by the Extension http://fhir-registry\.smarthealthit\.org/StructureDefinition/oauth-uris},
|
@@ -0,0 +1,34 @@
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1
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+
Req Set,ID,URL,Requirement,Conformance,Actors,Sub-Requirement(s),Conditionality,Not Tested Reason,Not Tested Details
|
2
|
+
hl7.fhir.us.cancer-reporting_1.0.1,1,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#claiming-conformance-to-this-specification,"This specification conforms to US Core Profiles, to claim conformance to this specification, servers [data suppliers] SHALL: … Be able to populate all profile data elements that have a minimum cardinality >= 1",SHALL,Data Supplier,,false,,
|
3
|
+
hl7.fhir.us.cancer-reporting_1.0.1,2,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#claiming-conformance-to-this-specification,"This specification conforms to US Core Profiles, to claim conformance to this specification, servers [data supplier] SHALL: … Be able to populate all profile data elements … flagged as Must Support as defined by that profile’s StructureDefinition",SHALL,Data Supplier,,true,,
|
4
|
+
hl7.fhir.us.cancer-reporting_1.0.1,3,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#claiming-conformance-to-this-specification,"To claim conformance to this specification, servers [data supplier] SHALL: ... Conform to this IG’s Server Capability Statement expectations",SHALL,Data Supplier,"hl7.fhir.us.cancer-reporting_1.0.1@15,16,17",true,,
|
5
|
+
hl7.fhir.us.cancer-reporting_1.0.1,4,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"As part of the sending of a US Pathology Bundle [([definition](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html))], the Sender SHALL be capable of including all elements defined in the profiles that have a MustSupport flag",SHALL,Report Creator,,false,,
|
6
|
+
hl7.fhir.us.cancer-reporting_1.0.1,5,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"As part of the sending of a US Pathology Bundle [([definition](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html))], the Sender ... SHALL populate all elements with a MustSupport flag if the information exists",SHALL,Report Creator,,false,,
|
7
|
+
hl7.fhir.us.cancer-reporting_1.0.1,6,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"In situations where information on a particular data element is not present, the Sender SHALL NOT include the data element in the resource instance if the cardinality is 0..n",SHALL NOT,Report Creator,,true,,
|
8
|
+
hl7.fhir.us.cancer-reporting_1.0.1,7,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"If the information does not exist and the cardinality of the element is >= 1..*, the Sender [of the [US Pathology Bundle](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)] SHALL use the [dataAbsentReason](http://hl7.org/fhir/ValueSet/data-absent-reason) extension where it is defined. ",SHALL,Report Creator,,true,,
|
9
|
+
hl7.fhir.us.cancer-reporting_1.0.1,8,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,Populating the element [in the [US Pathology Bundle](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)] with the value set absent reason or using the dataAbsent Reason SHOULD be handled by the Sending System and not require provider action.,SHOULD,Report Creator,,true,,
|
10
|
+
hl7.fhir.us.cancer-reporting_1.0.1,9,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,The Receiving System [of the [US Pathology Bundle](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)] SHALL be capable of processing resource instances containing required and allowed data elements without generating an error or causing the application to fail.,SHALL,Report Receiver,,true,,
|
11
|
+
hl7.fhir.us.cancer-reporting_1.0.1,10,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"Receiving Systems [of the [US Pathology Bundle](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)] SHOULD be capable of processing (display, store, etc.) the data elements based on the utility of the specific element to the receiver.",SHOULD,Report Receiver,,true,,
|
12
|
+
hl7.fhir.us.cancer-reporting_1.0.1,11,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"When receiving a US Pathology Bundle [([definition](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html))] from the Sender, the Receiving System SHALL interpret missing data elements within resource instances as data not present in the Senders systems.",SHALL,Report Receiver,,true,,
|
13
|
+
hl7.fhir.us.cancer-reporting_1.0.1,12,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,Receiving Systems [of the [US Pathology Bundle](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)] SHALL be able to process resource instances containing data elements asserting missing information [following [US Core requirements](https://hl7.org/fhir/us/core/STU5/general-requirements.html#missing-data)] without generating an error or causing the application to fail.,SHALL,Report Receiver,,true,,
|
14
|
+
hl7.fhir.us.cancer-reporting_1.0.1,13,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#conformance-to-us-core-profile,"Where this IG does not additionally constrain a US Core profile, the actors shall follow the US Core definition of [Must Support and Missing Data](http://hl7.org/fhir/us/core/general-guidance.html)",SHALL,Data Supplier,,false,,
|
15
|
+
hl7.fhir.us.cancer-reporting_1.0.1,14,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#privacy-and-security,Systems implementing this guide are expected to follow the general [FHIR Security guidelines](https://www.hl7.org/fhir/security.html),SHALL,"Data Supplier, Report Creator Report Receiver",,false,,
|
16
|
+
hl7.fhir.us.cancer-reporting_1.0.1,15,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#privacy-and-security,Systems implementing this guide are expected to follow ... applicable public and private laws and policies.,SHALL,"Data Supplier, Report Creator Report Receiver",,false,,
|
17
|
+
hl7.fhir.us.cancer-reporting_1.0.1,16,https://www.hl7.org/fhir/us/cancer-reporting/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#rest,"The focus of the EHR is to allow creation, modification and deletion of ServiceRequests",SHALL,Data Supplier,,false,,
|
18
|
+
hl7.fhir.us.cancer-reporting_1.0.1,17,https://www.hl7.org/fhir/us/cancer-reporting/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#rest,The focus of the EHR is to allow ... searching and retrieval of resources using US Core APIs,SHALL,Data Supplier,,true,,
|
19
|
+
hl7.fhir.us.cancer-reporting_1.0.1,18,https://www.hl7.org/fhir/us/cancer-reporting/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#rest,Implementations must meet the general security requirements documented in the security section of the implementation guide,SHALL,Data Supplier,"hl7.fhir.us.cancer-reporting_1.0.1@14,15",false,,
|
20
|
+
hl7.fhir.us.cancer-reporting_1.0.1,19,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#resourcesCap1,"[SHALL Support the following interactions for [ServiceRequest] (https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#ServiceRequest1-1): read, create, update, delete]",SHALL,Data Supplier,,false,,
|
21
|
+
hl7.fhir.us.cancer-reporting_1.0.1,20,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root,This MessageHeader profile [([definition](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root))] is expected to be used [when reporting cancer pathology information] by systems when sending to public health registries.,SHALL,Report Creator,,false,,
|
22
|
+
hl7.fhir.us.cancer-reporting_1.0.1,21,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root,This MessageHeader profile [([definition](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root))] is expected to be used [when receiving cancer pathology information] by systems when sending to public health registries.,SHALL,Report Receiver,,false,,
|
23
|
+
hl7.fhir.us.cancer-reporting_1.0.1,22,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root,"This MessageHeader profile [([definition](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root))] ... is not expected and not appropriate to be used in any other cases, such as when information exchange between a pathology laboratory and a clinical EHR system.",SHOULD NOT,Report Creator,,false,,
|
24
|
+
hl7.fhir.us.cancer-reporting_1.0.1,23,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,This [[US Pathology Cancer Registry Content Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html)] profile defines the structure of a bundle [when reporting cancer pathology information from a] pathology information environment [LIS] to an EHR environment.,SHALL,Report Creator,,false,,
|
25
|
+
hl7.fhir.us.cancer-reporting_1.0.1,24,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,This [[US Pathology Cancer Registry Content Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html)] profile defines the structure of a bundle [when reporting cancer pathology information from a] pathology information environment [LIS] to an EHR environment.,SHALL,Report Receiver,,false,,
|
26
|
+
hl7.fhir.us.cancer-reporting_1.0.1,25,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,This [[US Pathology Cancer Registry Content Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html)] profile ... is not intended for central cancer registry reporting.,SHALL NOT,Report Creator,,false,,
|
27
|
+
hl7.fhir.us.cancer-reporting_1.0.1,26,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,[Use the] US Pathology Registry Bundle [([definition](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-reporting-bundle.html))] for [reporting from the EHR to the public health registry],SHALL,Report Creator,,false,,
|
28
|
+
hl7.fhir.us.cancer-reporting_1.0.1,27,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,[Use the] US Pathology Registry Bundle [([definition](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-reporting-bundle.html))] for [reporting from the EHR to the public health registry],SHALL,Report Receiver,,false,,
|
29
|
+
hl7.fhir.us.cancer-reporting_1.0.1,28,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,"US Core profiles are expected for Encounter, Organization, Patient, Practitioner, and Procedure [instances referenced and included in the [US Pathology Cancer Registry Content Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html)], when such information is known",SHOULD,Report Creator,,true,,
|
30
|
+
hl7.fhir.us.cancer-reporting_1.0.1,29,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html#root,This [[US Pathology Exchange Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html)] collection bundle profile defines the structure [and should be used] for reporting to central cancer registry reporting from a pathology environment and/or from an EHR enviroment.,SHALL,Report Creator,,false,,
|
31
|
+
hl7.fhir.us.cancer-reporting_1.0.1,30,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html#root,This [[US Pathology Exchange Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html)] collection bundle profile defines the structure [and should be used] for reporting to central cancer registry reporting from a pathology environment and/or from an EHR enviroment.,SHALL,Report Receiver,,false,,
|
32
|
+
hl7.fhir.us.cancer-reporting_1.0.1,31,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html#root,"To properly process this [[US Pathology Exchange](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html)] transaction bundle, post to the root endpoint of the server (rather than the Bundle endpoint).",SHALL,Report Creator,,false,,
|
33
|
+
hl7.fhir.us.cancer-reporting_1.0.1,32,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html#root,"US Core profiles are expected for Encounter, Organization, Patient, Practitioner, and Procedure [instances referenced and included in the [US Pathology Exchange Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html)], when such information is known",SHOULD,Report Creator,,true,,
|
34
|
+
hl7.fhir.us.cancer-reporting_1.0.1,33,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-diagnostic-report.html,[When using the [US Pathology Diagnostic Report profile](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-diagnostic-report.html)] It is expected that labs will populate dateTimes with the most specific time information known when sending to EHRs (YYYY-MM-DD).,SHALL,Report Creator,,false,,
|
@@ -0,0 +1,11 @@
|
|
1
|
+
Req Set,ID,URL,Requirement,Conformance,Actors,Conditionality,Not Tested Reason,Not Tested Details,Cancer Pathology Data Sharing Data Access Test Suite Short ID(s),Cancer Pathology Data Sharing Data Access Test Suite Full ID(s)
|
2
|
+
hl7.fhir.us.cancer-reporting_1.0.1,1,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#claiming-conformance-to-this-specification,"This specification conforms to US Core Profiles, to claim conformance to this specification, servers [data suppliers] SHALL: … Be able to populate all profile data elements that have a minimum cardinality >= 1",SHALL,Data Supplier,false,,,"",""
|
3
|
+
hl7.fhir.us.cancer-reporting_1.0.1,2,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#claiming-conformance-to-this-specification,"This specification conforms to US Core Profiles, to claim conformance to this specification, servers [data supplier] SHALL: … Be able to populate all profile data elements … flagged as Must Support as defined by that profile’s StructureDefinition",SHALL,Data Supplier,true,,,"",""
|
4
|
+
hl7.fhir.us.cancer-reporting_1.0.1,3,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#claiming-conformance-to-this-specification,"To claim conformance to this specification, servers [data supplier] SHALL: ... Conform to this IG’s Server Capability Statement expectations",SHALL,Data Supplier,true,,,"",""
|
5
|
+
hl7.fhir.us.cancer-reporting_1.0.1,13,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#conformance-to-us-core-profile,"Where this IG does not additionally constrain a US Core profile, the actors shall follow the US Core definition of [Must Support and Missing Data](http://hl7.org/fhir/us/core/general-guidance.html)",SHALL,Data Supplier,false,,,"",""
|
6
|
+
hl7.fhir.us.cancer-reporting_1.0.1,14,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#privacy-and-security,Systems implementing this guide are expected to follow the general [FHIR Security guidelines](https://www.hl7.org/fhir/security.html),SHALL,"Data Supplier,Report Creator Report Receiver",false,,,"",""
|
7
|
+
hl7.fhir.us.cancer-reporting_1.0.1,15,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#privacy-and-security,Systems implementing this guide are expected to follow ... applicable public and private laws and policies.,SHALL,"Data Supplier,Report Creator Report Receiver",false,,,"",""
|
8
|
+
hl7.fhir.us.cancer-reporting_1.0.1,16,https://www.hl7.org/fhir/us/cancer-reporting/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#rest,"The focus of the EHR is to allow creation, modification and deletion of ServiceRequests",SHALL,Data Supplier,false,,,"",""
|
9
|
+
hl7.fhir.us.cancer-reporting_1.0.1,17,https://www.hl7.org/fhir/us/cancer-reporting/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#rest,The focus of the EHR is to allow ... searching and retrieval of resources using US Core APIs,SHALL,Data Supplier,true,,,"",""
|
10
|
+
hl7.fhir.us.cancer-reporting_1.0.1,18,https://www.hl7.org/fhir/us/cancer-reporting/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#rest,Implementations must meet the general security requirements documented in the security section of the implementation guide,SHALL,Data Supplier,false,,,"",""
|
11
|
+
hl7.fhir.us.cancer-reporting_1.0.1,19,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#resourcesCap1,"[SHALL Support the following interactions for [ServiceRequest] (https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/CapabilityStatement-central-cancer-registry-reporting-ehr-pathology.html#ServiceRequest1-1): read, create, update, delete]",SHALL,Data Supplier,false,,,"",""
|
@@ -0,0 +1,16 @@
|
|
1
|
+
Req Set,ID,URL,Requirement,Conformance,Actors,Conditionality,Not Tested Reason,Not Tested Details,Cancer Pathology Data Sharing Report Generation Test Suite Short ID(s),Cancer Pathology Data Sharing Report Generation Test Suite Full ID(s)
|
2
|
+
hl7.fhir.us.cancer-reporting_1.0.1,4,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"As part of the sending of a US Pathology Bundle [([definition](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html))], the Sender SHALL be capable of including all elements defined in the profiles that have a MustSupport flag",SHALL,Report Creator,false,,,"",""
|
3
|
+
hl7.fhir.us.cancer-reporting_1.0.1,5,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"As part of the sending of a US Pathology Bundle [([definition](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html))], the Sender ... SHALL populate all elements with a MustSupport flag if the information exists",SHALL,Report Creator,false,,,"",""
|
4
|
+
hl7.fhir.us.cancer-reporting_1.0.1,6,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"In situations where information on a particular data element is not present, the Sender SHALL NOT include the data element in the resource instance if the cardinality is 0..n",SHALL NOT,Report Creator,true,,,"",""
|
5
|
+
hl7.fhir.us.cancer-reporting_1.0.1,7,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,"If the information does not exist and the cardinality of the element is >= 1..*, the Sender [of the [US Pathology Bundle](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)] SHALL use the [dataAbsentReason](http://hl7.org/fhir/ValueSet/data-absent-reason) extension where it is defined. ",SHALL,Report Creator,true,,,"",""
|
6
|
+
hl7.fhir.us.cancer-reporting_1.0.1,8,https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/specification.html#must-support-and-missing-data,Populating the element [in the [US Pathology Bundle](https://hl7.org/fhir/us/cancer-reporting/STU1.0.1/StructureDefinition-us-pathology-exchange-bundle.html)] with the value set absent reason or using the dataAbsent Reason SHOULD be handled by the Sending System and not require provider action.,SHOULD,Report Creator,true,,,"",""
|
7
|
+
hl7.fhir.us.cancer-reporting_1.0.1,20,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root,This MessageHeader profile [([definition](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root))] is expected to be used [when reporting cancer pathology information] by systems when sending to public health registries.,SHALL,Report Creator,false,,,"",""
|
8
|
+
hl7.fhir.us.cancer-reporting_1.0.1,22,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root,"This MessageHeader profile [([definition](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-message-header.html#root))] ... is not expected and not appropriate to be used in any other cases, such as when information exchange between a pathology laboratory and a clinical EHR system.",SHOULD NOT,Report Creator,false,,,"",""
|
9
|
+
hl7.fhir.us.cancer-reporting_1.0.1,23,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,This [[US Pathology Cancer Registry Content Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html)] profile defines the structure of a bundle [when reporting cancer pathology information from a] pathology information environment [LIS] to an EHR environment.,SHALL,Report Creator,false,,,"",""
|
10
|
+
hl7.fhir.us.cancer-reporting_1.0.1,25,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,This [[US Pathology Cancer Registry Content Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html)] profile ... is not intended for central cancer registry reporting.,SHALL NOT,Report Creator,false,,,"",""
|
11
|
+
hl7.fhir.us.cancer-reporting_1.0.1,26,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,[Use the] US Pathology Registry Bundle [([definition](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-reporting-bundle.html))] for [reporting from the EHR to the public health registry],SHALL,Report Creator,false,,,"",""
|
12
|
+
hl7.fhir.us.cancer-reporting_1.0.1,28,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html#root,"US Core profiles are expected for Encounter, Organization, Patient, Practitioner, and Procedure [instances referenced and included in the [US Pathology Cancer Registry Content Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-content-bundle.html)], when such information is known",SHOULD,Report Creator,true,,,"",""
|
13
|
+
hl7.fhir.us.cancer-reporting_1.0.1,29,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html#root,This [[US Pathology Exchange Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html)] collection bundle profile defines the structure [and should be used] for reporting to central cancer registry reporting from a pathology environment and/or from an EHR enviroment.,SHALL,Report Creator,false,,,"",""
|
14
|
+
hl7.fhir.us.cancer-reporting_1.0.1,31,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html#root,"To properly process this [[US Pathology Exchange](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html)] transaction bundle, post to the root endpoint of the server (rather than the Bundle endpoint).",SHALL,Report Creator,false,,,"",""
|
15
|
+
hl7.fhir.us.cancer-reporting_1.0.1,32,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html#root,"US Core profiles are expected for Encounter, Organization, Patient, Practitioner, and Procedure [instances referenced and included in the [US Pathology Exchange Bundle](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-exchange-bundle.html)], when such information is known",SHOULD,Report Creator,true,,,"",""
|
16
|
+
hl7.fhir.us.cancer-reporting_1.0.1,33,https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-diagnostic-report.html,[When using the [US Pathology Diagnostic Report profile](https://www.hl7.org/fhir/us/cancer-reporting/StructureDefinition-us-pathology-diagnostic-report.html)] It is expected that labs will populate dateTimes with the most specific time information known when sending to EHRs (YYYY-MM-DD).,SHALL,Report Creator,false,,,"",""
|
Binary file
|
@@ -24,6 +24,14 @@ module CancerPathologyDataSharingTestKit
|
|
24
24
|
}
|
25
25
|
]
|
26
26
|
|
27
|
+
requirement_sets(
|
28
|
+
{
|
29
|
+
identifier: 'hl7.fhir.us.cancer-reporting_1.0.1',
|
30
|
+
title: 'Cancer Pathology Data Sharing IG STU 1.0.1',
|
31
|
+
actor: 'Data Supplier'
|
32
|
+
}
|
33
|
+
)
|
34
|
+
|
27
35
|
GENERAL_MESSAGE_FILTERS = [
|
28
36
|
%r{Sub-extension url 'introspect' is not defined by the Extension http://fhir-registry\.smarthealthit\.org/StructureDefinition/oauth-uris},
|
29
37
|
%r{Sub-extension url 'revoke' is not defined by the Extension http://fhir-registry\.smarthealthit\.org/StructureDefinition/oauth-uris},
|
metadata
CHANGED
@@ -1,14 +1,14 @@
|
|
1
1
|
--- !ruby/object:Gem::Specification
|
2
2
|
name: cancer_pathology_data_sharing_test_kit
|
3
3
|
version: !ruby/object:Gem::Version
|
4
|
-
version: 0.10.
|
4
|
+
version: 0.10.1
|
5
5
|
platform: ruby
|
6
6
|
authors:
|
7
7
|
- Inferno Team
|
8
8
|
autorequire:
|
9
9
|
bindir: bin
|
10
10
|
cert_chain: []
|
11
|
-
date: 2025-07-
|
11
|
+
date: 2025-07-30 00:00:00.000000000 Z
|
12
12
|
dependencies:
|
13
13
|
- !ruby/object:Gem::Dependency
|
14
14
|
name: inferno_core
|
@@ -92,6 +92,10 @@ files:
|
|
92
92
|
- lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/exchange_bundle/us_pathology_exchange_bundle/metadata.yml
|
93
93
|
- lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/exchange_bundle/us_pathology_exchange_bundle/us_pathology_exchange_bundle_must_support_test.rb
|
94
94
|
- lib/cancer_pathology_data_sharing_test_kit/report_generation_suite/exchange_bundle_group.rb
|
95
|
+
- lib/cancer_pathology_data_sharing_test_kit/requirements/cancer_pathology_data_sharing_test_kit_requirements.csv
|
96
|
+
- lib/cancer_pathology_data_sharing_test_kit/requirements/generated/cpds_data_access_requirements_coverage.csv
|
97
|
+
- lib/cancer_pathology_data_sharing_test_kit/requirements/generated/cpds_report_generation_requirements_coverage.csv
|
98
|
+
- lib/cancer_pathology_data_sharing_test_kit/requirements/hl7.fhir.us.cancer-reporting_1.0.1_requirements.xlsx
|
95
99
|
- lib/cancer_pathology_data_sharing_test_kit/urls.rb
|
96
100
|
- lib/cancer_pathology_data_sharing_test_kit/us_core_data_access_suite.rb
|
97
101
|
- lib/cancer_pathology_data_sharing_test_kit/us_core_data_access_suite/us_core_group.rb
|