Labeling

Think of this as the final, critical communication step that bridges all the testing and processing work directly to the physical unit of blood. Accurate labeling is absolutely paramount for patient safety – errors here can have devastating consequences. It’s governed by strict FDA regulations and AABB standards

Purpose and Importance

The primary goals of blood product labeling are to:

1. Uniquely Identify Each unit must have a unique identifier linking it back to the donor and all associated records (testing, processing history)
2. Accurately Describe Clearly state what the component is, its blood type, and any special characteristics
3. Provide Essential Information Give transfusion staff the critical details needed for safe storage and administration (expiration date, volume, etc.)
4. Ensure Traceability Facilitate tracking from donor to final disposition
5. Comply with Regulations Meet all legal and accreditation requirements

Regulatory Framework

• FDA (21 CFR 606, Subpart G - Container Labeling): Sets the mandatory requirements for information that must appear on blood component labels. Non-compliance can lead to regulatory action
• AABB Standards: Incorporate FDA requirements and often include additional best practices. AABB strongly promotes the use of the ISBT 128 standard
• ISBT 128: This isn’t a regulatory body, but an international standard for the terminology, identification, coding, and labeling of medical products of human origin (including blood). It uses standardized:
  • Barcodes: For machine readability, reducing transcription errors
  • Product Codes: Uniform codes for specific components and attributes
  • Data Structures: Consistent format for information like ABO/Rh, expiration date, donation ID
  • Why it’s important: Promotes global uniformity, enhances safety through automation, and improves traceability. Most US blood centers and transfusion services now use ISBT 128

Timing: The Critical Link to Testing & Release

This is crucial: The final container label, indicating the unit is suitable for transfusion, cannot be applied until

1. All mandatory testing (infectious disease markers, ABO/Rh) is completed
2. All test results have been reviewed and found to be acceptable (negative/non-reactive for diseases, ABO/Rh confirmed)
3. All processing steps are complete and records reviewed
4. The unit is officially released from quarantine

Before this point, units might have temporary labels or be held in quarantine with labels indicating their status (e.g., “Untested,” “Quarantine”). Applying the final label is the act that signifies the unit is ready for inventory and potential transfusion

Essential Information on the Final Container Label (Per FDA/AABB/ISBT 128)

While the exact layout follows ISBT 128 structure, the key information includes:

1. Unique Donation Identification Number (DIN) The primary identifier linking the unit to the donor and all records (often barcoded)
2. Component Name Standardized name (e.g., “Red Blood Cells Leukocytes Reduced,” “Platelets Pheresis,” “Plasma Frozen within 24 hours - PF24”). ISBT 128 uses specific product codes
3. ABO Group and Rh Type Clearly stated (e.g., “O POS,” “A NEG”). ISBT 128 has specific coded representations
4. Expiration Date and Time (if applicable) Critical for ensuring potency and safety
5. Volume or Weight Approximate amount of the component
6. Anticoagulant/Additive Solution Type and volume used
7. Storage Temperature Required range (e.g., “1-6 C,” “-18 C or colder”)
8. Collecting Facility Information Name and address or license/registration number
9. Donor Status Indication if “Volunteer Donor,” “Autologous Use Only,” or “Directed Donor”
10. Required Statements Such as “Rx Only,” “Properly Identify Intended Recipient,” “See Circular of Information…” etc
11. Biohazard Legend Standard symbol indicating biological material

Special Attribute Labeling

If a component has undergone modification or has specific characteristics, this must be clearly indicated on the label, often using specific ISBT 128 codes and eye-readable text:

• Irradiated: Indicates the unit has been irradiated to prevent TA-GVHD
• Leukocytes Reduced: Indicates the unit meets standards for leukocyte reduction
• CMV Seronegative: Indicates the donor tested negative for CMV antibodies
• Antigen Negative: Specifies red cell antigens the unit lacks (e.g., “Kell Negative,” “Fy(a-b-)”)
• Washed: Indicates the component has been washed to remove plasma
• Frozen/Thawed/Deglycerolized: For applicable RBC products
• Autologous Use Only: Mandatory for autologous units
• Directed Donor Information: Including intended recipient’s name/ID (if applicable)

The Labeling Process: Ensuring Accuracy

• Systems Approach: Labeling is usually integrated with the Blood Establishment Computer System (BECS). The system verifies test results and component information before allowing a label to be generated or applied
• Verification: Procedures must be in place to ensure the correct label is applied to the correct unit. This might involve barcode scanning comparisons or visual checks against records
• Label Quality: Labels must be legible, indelible (permanent ink, resistant to smudging/fading), and adhere securely to the container under storage conditions
• Error Prevention: Preventing labeling errors is a major focus of quality systems. Mislabeled units (e.g., wrong ABO/Rh) are a significant transfusion risk

Key Takeaway

Labeling is the final checkpoint in blood processing, translating complex testing and preparation into clear, standardized information on the unit itself. It requires meticulous accuracy, adherence to strict regulatory and formatting standards (like ISBT 128), and robust systems to prevent errors. Getting the label right is absolutely essential for ensuring the correct and safe transfusion for the patient

Key Terms

• ISBT 128: International standard for terminology, coding, and labeling of blood, cell, and tissue products
• Donation Identification Number (DIN): The unique number assigned to a specific blood donation, linking the unit, donor, and records
• Component Name (Product Code): Standardized name/code identifying the specific blood product (e.g., RBCs, Platelets Pheresis)
• Expiration Date: The date (and sometimes time) after which the component should not be transfused
• Quarantine: The status of a blood unit held pending completion and review of testing and processing
• Traceability: The ability to track a blood unit from donor to final disposition
• Circular of Information: A document providing detailed information about blood components, indications, contraindications, dosage, administration, and potential adverse effects, required by FDA to be available to transfusion services
• Attribute: A specific characteristic of a blood unit (e.g., Irradiated, CMV Negative, Antigen Negative) indicated on the label