Laboratory Testing SOP: GLP Compliance & Execution Guide

Standard Operating Procedure: Laboratory Testing Protocols

This document establishes the standardized workflow for the execution of laboratory tests to ensure data integrity, personnel safety, and compliance with institutional and regulatory standards. Adherence to these procedures is mandatory for all laboratory staff to minimize analytical error, ensure reproducibility, and maintain a safe environment. All procedures must be conducted in accordance with Good Laboratory Practice (GLP) and specific departmental safety guidelines.

Phase 1: Pre-Analytical Preparation

• Verification of Orders: Cross-reference testing requests with the Laboratory Information Management System (LIMS) to ensure specimen type, volume, and urgency align with the intended test.
• Equipment Calibration: Verify that all analytical instruments (e.g., pipettes, centrifuges, analyzers) have valid calibration stickers and have passed daily start-up self-checks.
• PPE Donning: Ensure appropriate Personal Protective Equipment (PPE) is worn, including lab coat, nitrile gloves, and eye protection, prior to handling any biological or chemical samples.
• Environment Check: Verify that ambient temperature and humidity in the laboratory meet the requirements specified in the instrument’s operation manual.

Phase 2: Specimen Handling and Processing

• Specimen Identification: Verify two patient identifiers (e.g., full name and DOB/MRN) on both the specimen label and the LIMS entry.
• Integrity Assessment: Inspect the sample for signs of hemolysis, lipemia, icterus, or insufficient volume before processing.
• Sample Preparation: Perform required aliquoting, centrifugation, or dilution exactly as specified by the Test Method Manual.
• Reagent Verification: Confirm all reagents are within their expiration dates and stored at the correct temperatures; document lot numbers if required by the protocol.

Phase 3: Analytical Execution

• Loading Samples: Place samples into the analyzer according to the prescribed mapping or load list. Ensure barcodes are readable and oriented correctly.
• Control Analysis: Run Quality Control (QC) samples (High/Low) prior to processing patient samples to validate the assay’s performance.
• Data Monitoring: Monitor the instrument during the run for error flags, hardware warnings, or unexpected interruptions.
• Validation of Results: Compare internal QC data against established Westgard Rules or moving averages before releasing patient results.

Phase 4: Post-Analytical and Reporting

• Review and Release: Conduct a final clinical review of results. Flag any "Critical Values" and ensure immediate notification to the ordering physician per institutional policy.
• Specimen Storage: Properly label and archive remaining patient specimens in the designated storage area (e.g., 4°C or -20°C) for the mandatory retention period.
• Decontamination: Perform a post-run wipe-down of all work surfaces with approved disinfectant.
• Waste Disposal: Dispose of hazardous waste, sharps, and biological materials according to biohazard protocols.

Pro Tips & Pitfalls

• The "Double-Check" Habit: Never rely on visual confirmation alone. Always scan barcodes to confirm identity. Human visual errors are the leading cause of pre-analytical testing failures.
• Avoid "QC Bias": Do not rerun controls multiple times hoping to achieve a "pass" result without investigating the root cause of the initial failure.
• Documentation is Key: If a deviation occurs, document it immediately. An undocumented action in a laboratory environment is considered a failure of protocol, regardless of the test outcome.
• Pipetting Accuracy: Always use the correct volume range for the pipette being used to prevent volumetric error.

Template Document: Laboratory Testing SOP: GLP Compliance & Execution Guide

This document serves as the official Standard Operating Procedure for laboratory testing under Good Laboratory Practice (GLP) standards. It is intended for use by all laboratory personnel, quality assurance staff, and technical managers involved in the execution and documentation of analytical testing.

• Document owner: [Department Name]
• Effective date: [Date]
• Version: [Version Number]
• Applies to: [Laboratory Unit or Process]

Roles and responsibilities

Steps

1. Verify that all laboratory equipment is calibrated according to the [Calibration Schedule] before starting any analytical procedure.
2. Confirm that the study protocol is approved and signed by the [Principal Investigator] prior to initiating specimen handling.
3. Label all specimen containers with a unique [Identification Code] and ensure they are stored at the required temperature of [Temperature Value].
4. Perform the analytical test using only validated methods as specified in the [Method Reference Number].
5. Record all observations, including any deviations from the protocol, in the [Laboratory Notebook] immediately upon occurrence.
6. Ensure that all reagents used during the testing process are within their [Expiration Date] and properly documented in the inventory log.
7. Verify that the analytical instrument settings match the parameters defined in the [Standard Operating Procedure Manual].
8. Calculate the final results using the validated [Formula or Software Version] and confirm that all values fall within the acceptable [Acceptance Range].
9. Perform a secondary review of the raw data to ensure that no transcription errors occurred during the [Data Entry Process].
10. Archive all electronic and physical records in the [Designated Storage Location] to maintain a complete audit trail for the duration of the [Retention Period].

Record of completion

• Prepared by: [Full name]
• Reviewed by: [Full name]
• Date completed: [Date]
• Signature: ______________________
• Date signed: [Date]

FAQ

Q: What should I do if a QC result falls outside the acceptable range? A: Cease all patient testing on that assay immediately. Identify the potential cause (expired reagents, expired controls, or calibration issues), resolve the issue, repeat the QC run successfully, and document the corrective action in the QC log.

Q: How long must patient samples be stored after testing? A: Retention periods vary by test type and local regulatory requirements. Refer to the 'Specimen Retention Schedule' in the Lab Policy Manual for specific timeframes.

Q: What is the procedure if a patient sample is received with inadequate labeling? A: The sample must be rejected. Do not attempt to guess the patient identity. Mark the sample as "Rejected - Improper Labeling" in the LIMS and contact the nursing station or requesting provider to facilitate a recollect.