# Work Instruction: [Title] | Document ID | WI-001 | |-------------|--------| | Title | [Title] | | Revision | 1.0 | | Effective Date | [DATE] | | Author | [AUTHOR] | | Approved By | [APPROVER] | | Department | Genetics & Genomics Laboratory | --- ## 1. Purpose [Describe the purpose of this work instruction - e.g., NGS library preparation, variant calling, DNA extraction] ## 2. Scope [Define what activities this instruction covers - e.g., specific assay, platform, sample types] ## 3. Safety Precautions - [List any safety requirements - biological hazards, chemical reagents] - [Personal protective equipment needed - lab coat, gloves, eye protection] - [Hazards to be aware of - ethidium bromide, formamide, liquid nitrogen] - [Biosafety level requirements] ## 4. Equipment/Materials Required | Item | Specification | Vendor/Catalog # | |------|---------------|------------------| | [Sequencing Platform] | [Model/Version] | [Vendor] | | [Reagent Kit] | [Kit Name/Version] | [Catalog #] | | [Software] | [Version] | [Source] | | | | | ## 5. Quality Control Materials | QC Material | Purpose | Acceptance Criteria | |-------------|---------|---------------------| | [Positive Control] | [Purpose] | [Criteria] | | [Negative Control] | [Purpose] | [Criteria] | | [Reference Standard] | [Purpose] | [Criteria] | ## 6. Pre-Procedure Setup ### 6.1 Sample Verification [Steps to verify sample identity, labeling, and chain of custody] ### 6.2 Equipment Preparation [Equipment calibration, cleaning, initialization steps] ### 6.3 Reagent Preparation [Reagent thawing, mixing, QC verification] ## 7. Procedure ### Step 1: [Title] [Detailed instructions with specific parameters] - [Sub-step with settings/values] - [Expected outcome/checkpoint] ### Step 2: [Title] [Detailed instructions] - [Sub-step] - [Expected outcome/checkpoint] ### Step 3: [Title] [Detailed instructions] - [Sub-step] - [Expected outcome/checkpoint] ## 8. Quality Metrics | Metric | Target Value | Action if Out of Spec | |--------|--------------|----------------------| | [Coverage Depth] | [>20x for germline] | [Repeat sequencing] | | [Q30 Score] | [>80%] | [Investigate/rerun] | | [Uniformity] | [>0.8] | [Troubleshoot] | | [Contamination] | [<3%] | [Reject sample] | ## 9. Acceptance Criteria [Define what constitutes successful completion] - [Criteria 1 with specific threshold] - [Criteria 2 with specific threshold] - [Criteria 3 with specific threshold] ## 10. Troubleshooting | Problem | Possible Cause | Solution | |---------|----------------|----------| | [Issue] | [Cause] | [Action] | | [Issue] | [Cause] | [Action] | ## 11. Records | Record | Location | Retention Period | |--------|----------|------------------| | [Run Log] | [LIMS/Path] | [CAP requirement] | | [QC Results] | [LIMS/Path] | [Minimum 2 years] | | [Variant Call Files] | [Secure Storage] | [Per CLIA/CAP] | ## 12. Data Management - [File naming conventions] - [Data backup procedures] - [Version control for pipelines/software] - [Data retention and archival] ## 13. References ### Related SOPs - [SOP-SEQ-XXX: NGS Quality Control] - [SOP-DM-XXX: Bioinformatics Data Management] - [SOP-GEN-XXX: Sample Tracking] ### Manufacturer Documentation - [Instrument User Guide, Version X] - [Reagent Kit Insert, Version X] - [Software Manual, Version X] ### Standards and Guidelines - [CAP Molecular Pathology Checklist] - [CLIA requirements] - [Relevant professional guidelines] --- ## Revision History | Rev | Date | Description | Author | |-----|------|-------------|--------| | 1.0 | [DATE] | Initial release | [AUTHOR] |