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SOPs/Specimen-Collection/SOP-BIO-001-Specimen-Collection.md
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SOPs/Specimen-Collection/SOP-BIO-001-Specimen-Collection.md
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# Standard Operating Procedure: Biological Specimen Collection
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| Document ID | SOP-BIO-001 |
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|-------------|-------------|
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| Title | Biological Specimen Collection Procedure |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Biobank Operations |
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---
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## 1. Purpose
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To establish standardized procedures for the collection, labeling, and initial processing of biological specimens to ensure sample integrity, proper chain of custody, and compliance with regulatory requirements.
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## 2. Scope
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This procedure applies to the collection of all biological specimens including:
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- Blood and blood components
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- Tissue samples (fresh and fixed)
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- Body fluids (CSF, urine, synovial fluid)
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- DNA/RNA samples
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- Cell lines and derivatives
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- FFPE blocks and slides
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## 3. Responsibilities
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### 3.1 Collection Personnel
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- Follow aseptic technique during collection
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- Complete all required labeling and documentation
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- Ensure proper specimen handling post-collection
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### 3.2 Biobank Coordinator
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- Train collection personnel
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- Verify specimen quality upon receipt
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- Maintain collection supply inventory
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### 3.3 Quality Manager
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- Review collection metrics
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- Investigate collection deviations
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- Approve collection protocols
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## 4. Definitions
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| Term | Definition |
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|------|------------|
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| Aliquot | A portion of a specimen separated for individual storage/testing |
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| Chain of Custody | Documented history of specimen handling and transfers |
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| Cryopreservation | Preservation of specimens at ultra-low temperatures |
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| FFPE | Formalin-Fixed Paraffin-Embedded tissue |
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## 5. Equipment and Materials
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- Collection tubes (type depends on specimen)
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- Sterile containers and cryovials
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- Labels (barcode and human-readable)
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- Collection kits per specimen type
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- PPE (gloves, gown, eye protection)
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- Temperature monitoring devices
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- Biohazard bags and containers
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## 6. Procedure
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### 6.1 Pre-Collection Preparation
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1. **Verify Consent Status**
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- Confirm informed consent on file
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- Verify consent covers intended specimen use
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- Document consent verification
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2. **Prepare Collection Materials**
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- Select appropriate collection containers
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- Pre-label containers with unique identifiers
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- Verify label accuracy against order
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- Prepare shipping/transport supplies if needed
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3. **Verify Patient/Donor Identity**
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- Use two patient identifiers
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- Compare against order/consent
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- Document verification method
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### 6.2 Specimen Collection
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#### 6.2.1 Blood Collection
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| Tube Type | Additive | Uses | Special Handling |
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|-----------|----------|------|------------------|
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| Red top | None (clot) | Serum | Allow to clot 30-60 min |
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| Lavender | EDTA | Plasma, CBC, DNA | Invert 8-10 times |
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| Green | Heparin | Plasma | Invert 8-10 times |
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| Blue | Citrate | Coagulation | Fill to line, invert |
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| Yellow | ACD | Cell preservation | Invert 8-10 times |
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1. Apply tourniquet (maximum 1 minute)
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2. Clean venipuncture site with 70% alcohol
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3. Perform venipuncture using appropriate needle gauge
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4. Fill tubes in correct order of draw
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5. Invert tubes as specified per type
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6. Label tubes immediately at bedside
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#### 6.2.2 Tissue Collection
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1. Receive tissue from surgical/procedure site
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2. Document time of removal from body
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3. Process according to protocol requirements:
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- **Fresh**: Place in appropriate medium immediately
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- **Frozen**: Snap-freeze in liquid nitrogen or place in -80°C within 30 minutes
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- **Fixed**: Place in 10% neutral buffered formalin (10:1 ratio)
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4. Record ischemia time (warm and cold)
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#### 6.2.3 Body Fluid Collection
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1. Use sterile technique throughout
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2. Collect into appropriate sterile container
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3. Record volume collected
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4. Transport to lab immediately or process per protocol
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### 6.3 Specimen Labeling
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**Required Label Information:**
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- [ ] Unique specimen identifier (barcode)
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- [ ] Patient/donor identifier
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- [ ] Collection date and time
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- [ ] Specimen type
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- [ ] Collector initials
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**Labeling Requirements:**
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- Label at point of collection
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- Use approved labels only
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- Never pre-label containers with patient info before collection
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- Verify label against patient ID band
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### 6.4 Initial Processing
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1. **Time-Critical Processing**
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- Process within stability window for specimen type
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- Document processing time
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- Note any delays and reason
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2. **Centrifugation (if required)**
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| Specimen | Speed | Time | Temperature |
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|----------|-------|------|-------------|
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| Serum | 1500-2000 x g | 10-15 min | Room temp |
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| Plasma (EDTA) | 1500-2000 x g | 10-15 min | 4°C preferred |
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| Plasma (citrate) | 2500 x g | 15 min | Room temp |
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3. **Aliquoting**
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- Use sterile technique
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- Aliquot into pre-labeled cryovials
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- Record number and volume of aliquots
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- Avoid multiple freeze-thaw cycles
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### 6.5 Storage and Transport
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1. **Immediate Storage**
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| Specimen Type | Storage Condition | Maximum Duration |
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|---------------|-------------------|------------------|
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| Fresh tissue | 4°C | 24 hours |
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| Fixed tissue | Room temp in formalin | 72 hours |
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| Frozen specimens | -80°C or LN2 | Long-term |
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| Blood tubes | Per tube type | See stability chart |
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2. **Transport Requirements**
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- Use validated shipping containers
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- Include temperature monitors
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- Complete chain of custody documentation
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- Verify receiving facility readiness
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## 7. Quality Control
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### 7.1 Collection Quality Metrics
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| Metric | Target | Frequency |
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|--------|--------|-----------|
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| Hemolysis rate | <2% | Monthly |
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| Labeling errors | 0 | Continuous |
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| Ischemia time compliance | >95% | Monthly |
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| Consent verification | 100% | Continuous |
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### 7.2 Deviation Handling
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- Document any deviation from SOP
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- Report to Biobank Coordinator immediately
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- Complete FRM-BIO-003 Deviation Report
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- Quarantine affected specimens pending review
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## 8. Documentation
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Required documentation for each collection:
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- FRM-BIO-001 Specimen Collection Log
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- FRM-BIO-002 Chain of Custody Form
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- Consent verification record
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- Any deviation reports
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## 9. Safety Considerations
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- Treat all specimens as potentially infectious
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- Use appropriate PPE for specimen type
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- Dispose of sharps in approved containers
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- Follow exposure control procedures
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- Report all exposures immediately
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## 10. References
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- ISBER Best Practices for Repositories (4th Edition)
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- CAP Biorepository Accreditation Checklist
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- NCI Best Practices for Biospecimen Resources
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- Institutional IRB policies
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---
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## Revision History
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||||
|
||||
| Rev | Date | Description | Author |
|
||||
|-----|------|-------------|--------|
|
||||
| 1.0 | [DATE] | Initial release | [AUTHOR] |
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