Managing Inconclusive Rule
Version: v3.0.0 Status: Normative (text), Illustrative (diagrams only) Scope: INCONCLUSIVE rule for detecting inconclusive sample results requiring repeat testing Domain: RULES-INCONCLUSIVE Precedence: Post-analysis (after well analysis engine)
Statement
The system shall detect and flag inconclusive sample results during PCR analysis by generating a WELL_INCONCLUSIVE error code when exactly one Non-IC target has a Positive classification.
The rule excludes Internal Control (IC) targets and passive targets from evaluation. Flagged wells become visible in the bulk management interface, enabling laboratory technicians to efficiently identify and process samples requiring repeat testing.
Quick Reference
| ID | Core Behavior | Priority | Status |
|---|---|---|---|
| REQ-RULES-INCONCLUSIVE-001 | Generate WELL_INCONCLUSIVE error when exactly one Non-IC target is Positive | HIGH | Draft |
Key Integration Points: Well Analysis Engine, Error Code System, Bulk Management Interface, Kit Configuration
Rule Summary
| Property | Value |
|---|---|
| Name | INCONCLUSIVE |
| Triggers | Exactly one Non-IC target has Positive classification |
| Output | WELL_INCONCLUSIVE error code |
| Purpose | Enable bulk management of inconclusive samples |
Rule Flowchart (Illustrative)
This diagram illustrates the core rule logic. The rule evaluates only Non-IC, non-passive targets and triggers only when exactly one has a Positive classification.
Definitions
| Term | Definition |
|---|---|
| Inconclusive Result | A sample result pattern where exactly one Non-IC target has a Positive classification |
| Non-IC Target | A target that is not an Internal Control (IC) target |
| Passive Target | A target whose CLS and CT values are excluded from trigger evaluation |
| CLS | Classification value assigned to a target in well analysis |
| CT | Cycle Threshold value for a target |
| WELL_INCONCLUSIVE | Error code applied to wells with inconclusive result patterns |
Assumptions
- Wells have been processed through the analysis engine before rule evaluation
- Target classifications (CLS) are available for all active targets in the well
- Internal Control (IC) targets are identifiable and marked in the system
- Passive targets are identifiable and flagged in the well configuration
- Bulk management functionality is available for handling flagged results
- Kit configuration has enabled the INCONCLUSIVE rule for the specific assay being processed
Requirements
Inconclusive Sample Detection (REQ-RULES-INCONCLUSIVE-001)
FR-INCONCLUSIVE-001: Generate Inconclusive Sample Error
The system shall generate a WELL_INCONCLUSIVE error code when a sample result is determined to be inconclusive based on target classification patterns.
Inputs/Outputs
| Direction | Data | Source/Target |
|---|---|---|
| Input | Well targets (CLS, IC flag, passive flag) | Well Analysis Engine |
| Input | Rule enablement status | Kit Configuration |
| Output | WELL_INCONCLUSIVE error code | Error Code System |
| Output | Flagged well visibility | Bulk Management Interface |
Acceptance Criteria
Trigger Condition:
- Apply the WELL_INCONCLUSIVE error code when exactly one Non-IC target has a Positive classification
- The trigger condition requires exactly one (not zero, not more than one) Non-IC target with Positive classification
- Do not apply any error code when the end case condition is not met
Target Exclusions:
- Exclude Internal Control (IC) targets from the trigger condition evaluation
- Rule evaluation shall consider only Non-IC (non-Internal Control) targets for the trigger condition
- Exclude passive target CLS and CT values from trigger evaluation
- Passive targets shall be identified by their passive flag status in well configuration
Bulk Management Integration:
- The error flag shall enable identification of inconclusive samples via bulk management functionality
Trigger Conditions
| End Case | Error Code |
|---|---|
| Only 1 Non-IC Target has a Positive classification | WELL_INCONCLUSIVE |
Error Handling
- Zero or more than one Non-IC target with Positive classification: no error code applied
- Rule disabled for assay: rule does not evaluate
Trace: Source: 3.0.0-Managing Inconclusive samples (Rule Description, Context, Objective, Success metrics table, Acceptance Criteria) | Jira: BT-674 | Epic: BT-674 | Tests: See scenarios
Configuration Options
| Option | Default | Description | Affects |
|---|---|---|---|
inconclusive_rule_enabled | false | Enable INCONCLUSIVE rule for the assay (client-specific configuration) | REQ-RULES-INCONCLUSIVE-001 |
Notes:
- Configuration is client-specific (e.g., Quest Diagnostics)
- Rule activation requires config sheet deployment on the server
UI Notes (Illustrative)
REQ-RULES-INCONCLUSIVE-001 UI Specifications
Bulk Manage Integration:
- The WELL_INCONCLUSIVE error code integrates with the bulk manage functionality
- Lab technicians can filter and view all inconclusive results
- Lab technicians can select multiple inconclusive samples
- Lab technicians can apply bulk actions to mark samples for repeat
Workflow Integration:
- Sample processing generates an Inconclusive result
- INCONCLUSIVE rule triggers and applies WELL_INCONCLUSIVE error code
- Error flag enables visibility in bulk manage interface
- Lab technicians can select and mark flagged results for repeat testing
- Resolution workflow processes the flagged samples
Implementation (Illustrative)
| Component | Location |
|---|---|
| InconclusiveRule | Analyzer/Rules/InconclusiveRule.php |
Traceability Matrix
| Requirement | Title | Verification | Implementation | Test Cases | Status |
|---|---|---|---|---|---|
| REQ-RULES-INCONCLUSIVE-001 | Generate Inconclusive Sample Error | Test | InconclusiveRule | See scenarios | Draft |
Notes
- This rule supports workflows where inconclusive results require sample repeat (e.g., Quest laboratories)
- The rule enables batch processing of inconclusive samples through the bulk manage interface
- Prior to this rule, inconclusive results in pcr.ai were not automatically flagged, preventing efficient bulk management
- Target Release: 2.7.0
Acceptance Tests
Test: REQ-RULES-INCONCLUSIVE-001
Test: Inconclusive result triggers error code
Given: A well with multiple targets being evaluated
And: Exactly one Non-IC target has a Positive classification
When: The INCONCLUSIVE rule evaluates the well
Then: The system shall apply the WELL_INCONCLUSIVE error code
And: The well shall be flagged for bulk management visibility
Test: Passive targets excluded from evaluation
Given: A well with passive targets
And: Passive target CLS and CT values exist
When: The INCONCLUSIVE rule evaluates the trigger condition
Then: The system shall ignore passive targets in trigger evaluation
And: Only active Non-IC targets shall be considered
Test: No error when condition not met
Given: A well where no end case condition is met
And: Either zero or more than one Non-IC target has Positive classification
When: The INCONCLUSIVE rule evaluates the well
Then: No error code shall be applied
And: The well shall not be flagged
Test: IC targets excluded from trigger condition
Given: A well with Internal Control (IC) targets
And: IC targets have various classifications
When: The INCONCLUSIVE rule evaluates the trigger condition
Then: IC targets shall be excluded from the count
And: Only Non-IC targets with Positive classification shall be counted
Related Design Documents
| Design Document | Relevant Sections |
|---|---|
| SDD Algorithms | Rule Engine |
Appendix: Process Artifacts
Completion Checklist
- All requirements are capability-level (describe behavior, not UI)
- Requirement variants consolidated (no requirement explosion) - N/A (single requirement)
- UI details are fully demoted to illustrative section
- Configuration options are not encoded as requirements
- Acceptance criteria describe behavior, not UI mechanics
- Every requirement has acceptance criteria and source traceability
- Error handling addressed for rule logic
- Open questions documented with owners assigned - None identified
- Consolidations documented in Reviewer Notes with reversibility info
- Module can survive a full UI redesign unchanged
- Refinements folded into acceptance criteria
- Traceability matrix is complete
Reviewer Notes
No Consolidation Required
This domain contains a single requirement (REQ-RULES-INCONCLUSIVE-001) representing one distinct system capability. No consolidation was performed as there was no requirement explosion pattern in the source material.
Source Mapping:
| Original Item | Source Reference | Disposition |
|---|---|---|
| REQ-RULES-INCONCLUSIVE-001 | 3.0.0-Managing Inconclusive samples | Preserved as REQ-RULES-INCONCLUSIVE-001 |
Conversion Notes:
- Given/When/Then scenarios from source preserved as detailed acceptance criteria
- Trigger conditions table preserved within requirement for clarity
- UI workflow details moved to UI Notes (Illustrative) section
- Configuration requirement (Quest config sheet) moved to Configuration Options section
- ACs grouped by concern (Trigger Condition, Target Exclusions, Bulk Management Integration)
Reversibility: To reference original structure:
- Source:
output/pilot/rules/rule-managing-inconclusive/rule-managing-inconclusive-restructured.md - SDD:
output/pilot/rules/rule-managing-inconclusive/sdd/rule-managing-inconclusive-design.md - Confluence: 3.0.0-Managing Inconclusive samples