LC-MS-IQ Known Limitations and Assumptions
Version 1.0
LCMS IQ, LLC
Purpose
This document describes known limitations, assumptions, dependencies, and operational constraints of LC-MS-IQ.
Users should review this document before relying upon software-generated outputs.
LC-MS-IQ is intended to assist qualified laboratory personnel and does not replace laboratory review or professional judgment.
General Limitation
LC-MS-IQ analyzes information provided to it.
The software assumes imported information accurately represents the analytical run being reviewed.
Incorrect, incomplete, corrupted, or improperly formatted input data may result in incorrect outputs.
Users are responsible for verifying imported information.
Decision-Support Tool
LC-MS-IQ is a decision-support tool.
The software does not:
- Make clinical decisions
- Approve patient results
- Release patient reports
- Validate methods
- Verify methods
- Determine regulatory compliance
- Determine accreditation compliance
Final decisions remain the responsibility of the laboratory.
Input File Dependency
LC-MS-IQ relies upon data exported from third-party software systems.
The software assumes exported information is accurate.
LCMS IQ, LLC does not verify:
- Instrument operation
- Instrument calibration
- Instrument maintenance
- Instrument qualification
- Export accuracy
- Export completeness
Errors originating in upstream systems may not be detected.
TargetLynx Dependency
Current versions of LC-MS-IQ are designed primarily around Waters TargetLynx exports.
Changes to export formats may affect software operation.
Future compatibility with modified export formats is not guaranteed.
Sample Naming Assumptions
Correct operation requires proper sample naming.
Calibration samples are expected to begin with:
CAL
Quality control samples are expected to begin with:
QC
Incorrect naming may result in:
- Misclassification
- Incorrect calculations
- Incorrect trend statistics
- Incorrect reporting decisions
Users are responsible for verifying sample naming conventions.
Zero-Level Assumptions
Calibration levels with concentration equal to zero are excluded from calibration calculations.
QC levels with target concentration equal to zero are excluded from QC calculations.
Users should verify that these assumptions are appropriate for their workflows.
Historical Statistics Limitations
Health monitoring, Westgard statistics, and trend calculations depend upon historical data quality.
Results may be affected by:
- Limited historical observations
- Improper sample classification
- Configuration changes
- Method changes
- Instrument changes
Historical calculations should be reviewed before action is taken.
Trend Eligibility
Historical calculations are based upon runs determined to be eligible for trending.
Runs may be excluded from historical calculations.
Excluded runs do not contribute to:
- Trend plots
- Baselines
- Westgard calculations
- Health monitoring statistics
Users should understand which runs are included and excluded.
Configuration Dependency
Software outputs depend upon configuration settings selected by the user.
Different configurations may produce different outputs from identical input data.
LCMS IQ, LLC does not determine whether user-selected thresholds are appropriate.
Users remain responsible for all acceptance criteria.
Peak Validation Limitations
Peak validation is based upon configured thresholds and available data.
The software cannot guarantee detection of all:
- Integration errors
- Chromatographic issues
- Quantitation issues
- Instrument failures
Laboratory review remains necessary.
Calibration Limitations
Calibration calculations rely upon:
- Imported concentrations
- Imported responses
- Imported curve information
Incorrect calibration information may result in incorrect outputs.
The software cannot guarantee that all calibration issues will be detected.
QC Limitations
QC calculations rely upon:
- Imported target values
- Imported measured values
- Historical observations
Incorrect QC information may result in incorrect outputs.
The software cannot guarantee detection of all QC issues.
Health Monitoring Limitations
Health monitoring is intended to identify potential analytical changes.
The software cannot guarantee:
- Detection of all failures
- Detection of all drift
- Detection of all performance issues
- Prediction of future failures
Health monitoring should be considered an aid to laboratory review.
Engineering Diagnostics Limitations
Engineering metrics are intended to assist troubleshooting activities.
Engineering outputs should not be considered definitive evidence of root cause.
Additional investigation may be required.
Software Availability
LC-MS-IQ may become unavailable temporarily or permanently.
Users are responsible for maintaining alternative procedures sufficient to continue operations.
LC-MS-IQ is not intended to serve as a mission-critical platform.
PHI Restriction
LC-MS-IQ is not intended to store or process:
- PHI
- ePHI
- Patient-identifiable information
Users are responsible for ensuring uploaded information complies with privacy requirements.
No Warranty of Detection
LC-MS-IQ does not guarantee that:
- All analytical problems will be identified.
- All quality issues will be identified.
- All instrument issues will be identified.
- All data quality issues will be identified.
Absence of warnings does not guarantee absence of problems.
User Responsibility
Users remain solely responsible for:
- Data review
- Data interpretation
- Quality decisions
- Reporting decisions
- Regulatory compliance
- Accreditation compliance
- Laboratory operations
Use of LC-MS-IQ does not transfer these responsibilities to LCMS IQ, LLC.
Acceptance
Use of LC-MS-IQ constitutes acknowledgment and acceptance of these limitations and assumptions.