LC-MS-IQ Intended Use, Limitations, and User Responsibilities

Version 1.0

LCMS IQ, LLC

Intended Use

LC-MS-IQ is a software application designed to assist laboratories in the review of LC-MS/MS analytical data.

The software provides automated data analysis, quality review, trend analysis, calibration assessment, quality control assessment, peak validation, health monitoring, and troubleshooting support functions.

LC-MS-IQ is intended solely as a laboratory quality review and decision-support tool.

The software is intended to assist qualified laboratory personnel in identifying potential analytical issues and reviewing analytical performance.

All final analytical, operational, quality, regulatory, accreditation, reporting, and clinical decisions remain the responsibility of the user.

Intended Users

LC-MS-IQ is intended for use by:

• Laboratory directors
• Technical supervisors
• Clinical laboratory scientists
• Medical technologists
• Quality personnel
• Method development personnel
• LC-MS/MS specialists
• Service and support personnel

Users should possess appropriate training and experience in laboratory operations and LC-MS/MS technology.

Intended Data Types

LC-MS-IQ is intended to analyze laboratory-generated analytical data including:

• Calibration data
• Quality control data
• Peak integration data
• Instrument performance data
• Trend data
• Method performance data

The software is intended for analytical quality review purposes only.

Not Intended For

LC-MS-IQ is NOT intended for:

• Clinical diagnosis
• Patient management
• Medical decision making
• Treatment decisions
• Method validation
• Method verification
• Establishment of reportable ranges
• Determination of analytical sensitivity
• Determination of analytical specificity
• Determination of accuracy
• Determination of precision
• Establishment of reference intervals
• CLIA validation requirements
• CAP validation requirements
• FDA submissions
• Regulatory submissions
• Accreditation compliance determinations
• Quality system replacement
• Laboratory information system functions
• Electronic medical record functions

Method Validation Disclaimer

LC-MS-IQ does not validate analytical methods.

LC-MS-IQ does not determine whether an analytical method is suitable for patient testing.

LC-MS-IQ does not establish analytical performance characteristics.

Use of LC-MS-IQ does not satisfy any laboratory obligation to perform method validation, method verification, quality assurance activities, proficiency testing, or regulatory compliance activities.

Any use of LC-MS-IQ in support of method validation, verification, accreditation, or regulatory activities is solely the responsibility of the user and is outside the intended use of the software.

No Clinical Function

LC-MS-IQ is not a medical device.

LC-MS-IQ does not diagnose, treat, monitor, cure, or prevent disease.

LC-MS-IQ does not generate patient reports.

LC-MS-IQ does not determine patient eligibility for treatment.

LC-MS-IQ does not provide clinical recommendations.

Data Limitations

LC-MS-IQ analyzes data provided by the user.

The software assumes imported files accurately represent the analytical run being reviewed.

The software does not independently verify:

• Instrument performance
• Sample preparation
• Calibration preparation
• QC preparation
• Instrument configuration
• Chromatographic conditions
• Mass spectrometer operation

Incorrect input data may result in incorrect output.

Users are responsible for verifying all imported information.

Sample Naming Requirements

Correct operation requires proper sample naming and classification.

Calibration samples, QC samples, blanks, unknowns, and other sample types must be properly identified according to software requirements.

Improper naming may result in incorrect classification and analysis.

Users are responsible for verifying sample naming conventions.

Historical Statistics Limitations

Historical statistics, health monitoring results, Westgard calculations, trend analyses, and baseline calculations are dependent upon historical data quality.

Incorrect, incomplete, or improperly classified data may affect future calculations.

Users are responsible for reviewing historical statistics before acting upon software-generated conclusions.

PHI and Patient Information Restrictions

LC-MS-IQ is not intended for storage or processing of Protected Health Information (PHI), electronic Protected Health Information (ePHI), or personally identifiable patient information.

Users should not upload:

• Patient names
• Medical record numbers
• Dates of birth
• Social Security numbers
• Patient identifiers
• HIPAA-regulated information

The user is solely responsible for ensuring that uploaded files comply with privacy requirements and organizational policies.

User Responsibility

The user remains solely responsible for:

• Data review
• Data interpretation
• Result reporting
• Quality decisions
• Regulatory compliance
• Accreditation compliance
• Laboratory procedures
• Method performance
• Patient testing activities

LC-MS-IQ is intended to assist users, not replace them.

Software Updates

Software updates may alter calculations, features, workflows, thresholds, displays, or reporting functionality.

Users are responsible for reviewing release notes and determining whether updates are appropriate for their environment.

Acceptance

Use of LC-MS-IQ constitutes acknowledgment and acceptance of the intended use, limitations, and responsibilities described herein.