biobank-repository/SOPs/Specimen-Collection/SOP-BIO-001-Specimen-Collection.md

Standard Operating Procedure: Biological Specimen Collection

Document ID	SOP-BIO-001
Title	Biological Specimen Collection Procedure
Revision	1.0
Effective Date	[DATE]
Author	[AUTHOR]
Approved By	[APPROVER]
Department	Biobank Operations

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1. Purpose

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.

2. Scope

This procedure applies to the collection of all biological specimens including:

• Blood and blood components
• Tissue samples (fresh and fixed)
• Body fluids (CSF, urine, synovial fluid)
• DNA/RNA samples
• Cell lines and derivatives
• FFPE blocks and slides

3. Responsibilities

3.1 Collection Personnel

• Follow aseptic technique during collection
• Complete all required labeling and documentation
• Ensure proper specimen handling post-collection

3.2 Biobank Coordinator

• Train collection personnel
• Verify specimen quality upon receipt
• Maintain collection supply inventory

3.3 Quality Manager

• Review collection metrics
• Investigate collection deviations
• Approve collection protocols

4. Definitions

Term	Definition
Aliquot	A portion of a specimen separated for individual storage/testing
Chain of Custody	Documented history of specimen handling and transfers
Cryopreservation	Preservation of specimens at ultra-low temperatures
FFPE	Formalin-Fixed Paraffin-Embedded tissue

5. Equipment and Materials

• Collection tubes (type depends on specimen)
• Sterile containers and cryovials
• Labels (barcode and human-readable)
• Collection kits per specimen type
• PPE (gloves, gown, eye protection)
• Temperature monitoring devices
• Biohazard bags and containers

6. Procedure

6.1 Pre-Collection Preparation

1. Verify Consent Status

   • Confirm informed consent on file
   • Verify consent covers intended specimen use
   • Document consent verification

2. Prepare Collection Materials

   • Select appropriate collection containers
   • Pre-label containers with unique identifiers
   • Verify label accuracy against order
   • Prepare shipping/transport supplies if needed

3. Verify Patient/Donor Identity

   • Use two patient identifiers
   • Compare against order/consent
   • Document verification method

6.2 Specimen Collection

6.2.1 Blood Collection

Tube Type	Additive	Uses	Special Handling
Red top	None (clot)	Serum	Allow to clot 30-60 min
Lavender	EDTA	Plasma, CBC, DNA	Invert 8-10 times
Green	Heparin	Plasma	Invert 8-10 times
Blue	Citrate	Coagulation	Fill to line, invert
Yellow	ACD	Cell preservation	Invert 8-10 times

1. Apply tourniquet (maximum 1 minute)
2. Clean venipuncture site with 70% alcohol
3. Perform venipuncture using appropriate needle gauge
4. Fill tubes in correct order of draw
5. Invert tubes as specified per type
6. Label tubes immediately at bedside

6.2.2 Tissue Collection

1. Receive tissue from surgical/procedure site
2. Document time of removal from body
3. Process according to protocol requirements:
   • Fresh: Place in appropriate medium immediately
   • Frozen: Snap-freeze in liquid nitrogen or place in -80°C within 30 minutes
   • Fixed: Place in 10% neutral buffered formalin (10:1 ratio)
4. Record ischemia time (warm and cold)

6.2.3 Body Fluid Collection

1. Use sterile technique throughout
2. Collect into appropriate sterile container
3. Record volume collected
4. Transport to lab immediately or process per protocol

6.3 Specimen Labeling

Required Label Information:

• Unique specimen identifier (barcode)
• Patient/donor identifier
• Collection date and time
• Specimen type
• Collector initials

Labeling Requirements:

• Label at point of collection
• Use approved labels only
• Never pre-label containers with patient info before collection
• Verify label against patient ID band

6.4 Initial Processing

1. Time-Critical Processing

   • Process within stability window for specimen type
   • Document processing time
   • Note any delays and reason

2. Centrifugation (if required)

   Specimen	Speed	Time	Temperature
   Serum	1500-2000 x g	10-15 min	Room temp
   Plasma (EDTA)	1500-2000 x g	10-15 min	4°C preferred
   Plasma (citrate)	2500 x g	15 min	Room temp

3. Aliquoting

   • Use sterile technique
   • Aliquot into pre-labeled cryovials
   • Record number and volume of aliquots
   • Avoid multiple freeze-thaw cycles

6.5 Storage and Transport

1. Immediate Storage

   Specimen Type	Storage Condition	Maximum Duration
   Fresh tissue	4°C	24 hours
   Fixed tissue	Room temp in formalin	72 hours
   Frozen specimens	-80°C or LN2	Long-term
   Blood tubes	Per tube type	See stability chart

2. Transport Requirements

   • Use validated shipping containers
   • Include temperature monitors
   • Complete chain of custody documentation
   • Verify receiving facility readiness

7. Quality Control

7.1 Collection Quality Metrics

Metric	Target	Frequency
Hemolysis rate	<2%	Monthly
Labeling errors	0	Continuous
Ischemia time compliance	>95%	Monthly
Consent verification	100%	Continuous

7.2 Deviation Handling

• Document any deviation from SOP
• Report to Biobank Coordinator immediately
• Complete FRM-BIO-003 Deviation Report
• Quarantine affected specimens pending review

8. Documentation

Required documentation for each collection:

• FRM-BIO-001 Specimen Collection Log
• FRM-BIO-002 Chain of Custody Form
• Consent verification record
• Any deviation reports

9. Safety Considerations

• Treat all specimens as potentially infectious
• Use appropriate PPE for specimen type
• Dispose of sharps in approved containers
• Follow exposure control procedures
• Report all exposures immediately

10. References

• ISBER Best Practices for Repositories (4th Edition)
• CAP Biorepository Accreditation Checklist
• NCI Best Practices for Biospecimen Resources
• Institutional IRB policies

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Revision History

Rev	Date	Description	Author
1.0	[DATE]	Initial release	[AUTHOR]