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Blood Bank

Tissue Management Storage & Distribution

In many healthcare institutions, the responsibility for managing human tissue allografts (bone, skin, tendons, heart valves, corneas) falls under the purview of the Transfusion Service or Blood Bank. This is not because tissues are blood products, but because Blood Bank already possesses the core competencies required for biological inventory management: rigorous temperature monitoring, bi-directional traceability, 24/7 staffing, and strict regulatory compliance. The administration of tissue management requires adherence to specific standards set by The Joint Commission (TJC), the FDA (21 CFR 1271), and the AABB

Regulatory Scope: HCT/Ps

Human tissues are classified by the FDA as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). They are distinct from blood components and usually distinct from organ transplants

  • The Joint Commission (TJC) Mandate: TJC standards strictly require hospitals to have a standardized, hospital-wide system for tracking tissues. While the Operating Room (OR) uses the products, they often lack the infrastructure for long-term tracking. Therefore, Administration frequently designates Blood Bank Manager as the “Tissue Compliance Officer.”
  • FDA 21 CFR 1271: This regulation governs the eligibility determination, screening, and testing of donors to prevent the transmission of communicable diseases. The receiving laboratory is responsible for verifying that the supplier is registered with the FDA and that the tissue comes with a “Certificate of Compliance” or “Statement of Eligibility.”

Receipt & Inspection (The Chain of Custody)

The integrity of a tissue graft begins at the loading dock. Unlike blood, which comes from a single contracted supplier, tissues may come from dozens of specialized biotech vendors

Verification Upon Receipt

Before a tissue is entered into inventory, a qualified staff member must verify and document specific criteria. If any criteria are unmet, the tissue must be quarantined or rejected

  • Shipping Conditions: Was the package intact? Was the temperature maintained? (e.g., Dry ice was still present for frozen grafts; coolant packs were cold for refrigerated grafts)
  • Documentation: The shipment must include a Package Insert (Instructions for Use) and a Certificate of Conformance. This certificate confirms the donor was screened for HIV, Hepatitis, Syphilis, and other relevant pathogens
  • Expiration Date: Verify that the product has sufficient shelf-life for its intended use
  • Integrity: Visual inspection of the packaging (vacuum seals, bottles) to ensure sterility has not been compromised

Storage Requirements & Environmental Monitoring

Tissues have diverse storage requirements compared to the relatively uniform needs of blood products. The laboratory administrator must ensure the facility has the appropriate hardware to support these ranges

Storage Categories

  • Ambient (Room Temperature): Freeze-dried bone chips, demineralized bone matrix (DBM) putty, and some tendons
    • Requirement: Controlled room temperature (\(20\text{-}25^\circ\text{C}\)). Humidity control is often critical to prevent package degradation
  • Refrigerated: Some skin grafts, amniotic membranes, and gels
    • Requirement: \(2\text{-}8^\circ\text{C}\). These can often share storage with Red Blood Cells if segregated clearly
  • Frozen: Tendons, ligaments, and femoral heads
    • Requirement: Usually \(-40^\circ\text{C}\) or colder. Standard household freezers are insufficient; laboratory-grade ultra-low freezers are required
  • Cryopreserved: Heart valves and vascular grafts
    • Requirement: Below \(-100^\circ\text{C}\) (often \(-150^\circ\text{C}\) in liquid nitrogen vapor). Handling these requires specialized PPE (cryo-gloves, face shields) to prevent thermal burns

Monitoring Systems

  • Continuous Monitoring: Just like blood fridges, tissue freezers must be monitored 24/7 with recording charts or digital loggers
  • Alarms: Systems must be equipped with audible and remote alarms to alert staff of temperature excursions
  • Emergency Plans: A backup freezer must be available and pre-chilled in case of primary equipment failure

Traceability (Bi-Directional Tracking)

The core legal requirement for tissue management is Traceability. In the event of a disease transmission (e.g., a donor is later found to have Rabies or Hepatitis C) or a manufacturer recall, the laboratory must be able to link the specific graft to the specific patient

The “Common Identifier”

  • ISBT 128 / Unique ID: Every piece of tissue has a unique alphanumeric serial number assigned by the supplier. This number must be recorded in the patient’s permanent medical record
  • Labeling: The lab should affix a supplemental label or tag to the package that includes the internal hospital tracking number or patient name (if assigned), without obscuring the manufacturer’s expiration date or ID number

The 10-Year Record

The Joint Commission and FDA generally require that tissue records be retrievable for at least 10 years (or indefinitely, depending on state law). The tracking system must be able to answer two questions instantly:

  1. Supplier to Patient “Supplier X is recalling Lot #123. Which patient received it?”
  2. Patient to Supplier: “Patient Y developed a weird infection. What specific tissues were implanted in them, and who manufactured them?”

Issuance & Distribution Logic

The workflow for issuing tissue differs from blood because tissues are often ordered in multiple sizes for a single surgery, with the surgeon deciding intra-operatively which size fits best

The “Pass-Through” Workflow

In many hospitals, Blood Bank acts as the central hub, but the tissue is stored in a satellite freezer in the Operating Room (OR)

  • Inventory Management: The Blood Bank staff performs daily/weekly rounds to the OR to check temperatures, restock inventory, and remove expired products
  • Consumption Documentation: When a tissue is used, the circulating nurse must complete a Tissue Implant Record (sticker or log) and return it to Blood Bank. This closes the loop in the Laboratory Information System (LIS)

Return to Inventory Criteria

Because tissues are expensive (often thousands of dollars per unit), maximizing usage is financially critical. However, safety is paramount

  • Unopened Items: Tissues taken to the OR but not used can be returned to inventory ONLY if:
    • The sterile seal is intact
    • The temperature was maintained within range during the entire time it was out of controlled storage. (e.g., A frozen tendon kept in a validated cooler with dry ice is acceptable; a tendon left on a prep table for 2 hours is not)
  • “Time Out of Environment”: Strict time limits must be defined in the SOP. If the limit is exceeded, the tissue must be discarded (Wastage)

Adverse Events & Recalls

Administration must have a rapid response plan for tissue-related adverse events

Recall Management

  • Notification: When a manufacturer issues a recall (e.g., due to compromised sterility in the factory), they notify the hospital
  • Action
    • In-Stock: Quarantine and return the tissue immediately
    • Implanted: Notify the Risk Management department and the implanting surgeon. The surgeon determines if the risk warrants explantation or just monitoring of the patient

Infection Investigation

  • If a patient develops a post-operative infection (Surgical Site Infection), Blood Bank may be asked to investigate
  • The Look-Back: The lab reviews the donor documentation for the implanted tissues to ensure no deviations occurred
  • Reporting: If the tissue is suspected as the source, the lab must report this to the Supplier (so they can stop distributing other tissues from that donor) and the FDA MedWatch program