Reporting and Documentation
At Splice Histology, our reporting process ensures complete traceability, accuracy, and compliance with industry standards. From the moment specimens enter our laboratory to the final analysis, every action is documented to maintain the highest level of quality assurance and transparency.
Overview
1. Chain of Custody
Purpose: To ensure the integrity of specimens and data throughout the workflow.
Workflow Details:
Specimen Receipt:
Documentation of receipt with date, time, and personnel involved.
Verification against accompanying requisition forms to ensure proper labeling and matching.
Labeling and Tracking:
Each specimen is assigned a unique identifier for end-to-end traceability.
Barcode or QR code integration for electronic tracking.
Secure Storage:
Specimens are stored in secure, temperature-controlled environments before processing.
Detailed logs are maintained for storage conditions and retrieval events.
Transfer Between Processes:
Every handoff between stages (e.g., grossing to processing, embedding to sectioning) is logged with time stamps and personnel responsible.
Chain of custody forms are updated at every stage to document specimen handling.
Report Generation:
Chain of custody summary included in final study reports.
2. In-Lab Processes
Purpose: To provide a clear, auditable record of all activities performed on each specimen.
Step-by-Step Documentation:
Grossing:
Record the personnel performing the grossing, description of the specimen, and sections selected
Processing:
Include details such as processing time, machine settings, and any deviations from standard protocol.
Embedding:
Note the technician responsible and any special considerations for orientation.
Sectioning:
Document the thickness of sections, number of slides created, and technician involved.
Staining:
Record the staining protocols used, batch numbers of reagents, and personnel performing the task.
Coverslipping:
Include details of mounting medium, coverslip application, and technician’s name.
Quality Checks:
Logs of QA/QC performed at each stage, with signatures of verifying personnel.
Re-processing or troubleshooting actions documented with reasons and outcomes.
Time Stamps:
Precise recording of when each stage is initiated and completed.
Digital Integration:
Use of laboratory information management systems (LIMS) to store process data securely.
3. Study Report Components
Purpose: To consolidate all specimen and process data into a comprehensive, accessible report.
Components:
Specimen Summary:
Patient or project identification (if applicable).
Specimen type, source, and unique identifier.
Process Overview:
Full workflow log from receipt to final analysis.
Personnel names and roles for each step.
Equipment used, with calibration or maintenance logs.
Chain of Custody Report:
Complete custody history with time stamps, locations, and handlers.
Protocol Adherence:
Confirmation of adherence to predefined protocols or documented deviations.
Quality Assurance Metrics:
QA/QC outcomes, including pass/fail criteria and corrective actions.
Imaging and Analysis Results:
High-resolution whole-slide images and associated diagnostic or research findings.
Any automated analysis data with algorithms used.
Conclusion and Interpretation:
Final diagnostic or research insights based on findings.
4. Data Security and Compliance
Purpose: To ensure all data and reports meet regulatory and confidentiality requirements.
Workflow: Details:
Data Protection:
All data stored in encrypted systems with controlled access.
Regular backups and secure archival procedures.
Compliance Standards:
Adherence to CAP (College of American Pathologists), CLIA (Clinical Laboratory Improvement Amendments), and HIPAA (Health Insurance Portability and Accountability Act) standards.
Auditable Records:
All documentation is retained for the required timeframes and made accessible for audits or inquiries.
Key Features of Splice Histology’s Reporting System
Transparency:
Every action and handler is accounted for in the report.
Accuracy:
Automated systems minimize errors and ensure precise documentation.
Client Accessibility:
Final reports include user-friendly summaries and detailed logs for review.
Regulatory Compliance:
Ensures alignment with all relevant standards for documentation and reporting.