Transfusion QA

04. Transfusion Medicine QA Framework

A. Clinical Quality Indicators (Patient Safety)

Focuses on the safety of the recipient.

1. Transfusion Reaction Rate:

   • Indicator: Number of adverse reactions reported vs. Total units transfused.[1]

   • Breakdown:

     • Acute: Hemolytic, Febrile Non-Hemolytic, Allergic/Anaphylactic, TRALI (Transfusion Related Acute Lung Injury), TACO (Circulatory Overload).

     • Delayed: Delayed Hemolysis, GVHD, Post-transfusion Purpura.

   • Target: < 0.5% (Strict reporting required under PvPI / Haemovigilance Programme of India).

2. Cross-match Transfusion (C:T) Ratio:

   • Indicator: Number of units Cross-matched vs. Number of units Transfused.

   • Significance: High ratio (> 2.5:1) implies surgeons are over-ordering blood "just in case," leading to wastage and inventory blocking.

   • Target: Ideal is < 2.0:1.

3. Turnaround Time (TAT) for Issue:

   • Emergency Cross-match: < 45-60 mins.

   • Routine Cross-match: < 4 hours.[7][8][9]

   • Un-crossmatched (O-Negative) Release: < 10-15 mins (Life-saving protocol).

4. Wastage Rate:

   • Indicator: % of units discarded.[1]

   • Reasons: Expiry (Outdating), Leakage, Hemolysis, Seropositivity (TTI), Power failure.

   • Target: < 1-2% for Red Cells; higher allowance for Platelets (due to short shelf life).

B. Technical Quality (Component "Manufacturing")

Since you "manufacture" components, you must QC the final product.

1. Quality Control of Components (Monthly Audit of 1% of units):

   • Packed Red Blood Cells (PRBC): Hematocrit (Hct) should be 65-75%; Hemoglobin > 45g/unit.

   • Platelet Concentrate (RDP): Volume > 50ml; Platelet count > 5.5 x 10^10 per bag; pH > 6.0.

   • Fresh Frozen Plasma (FFP): Volume > 200ml; Factor VIII activity > 0.7 IU/ml.

   • Cryoprecipitate: Fibrinogen > 140mg; Factor VIII > 80 IU per bag.

2. Transfusion Transmitted Infection (TTI) Rate:

   • Indicator: % of donor units reactive for HIV, HBsAg, HCV, Syphilis, and Malaria.

   • Process: "Reactive" units must be discarded, and the donor permanently deferred and counseled (confidentiality essential).

3. External Quality Assurance (EQAS):

   • Audit: Participation in EQAS for Immuno-hematology (Blood Grouping/Cross-matching) and TTI screening (e.g., from CMC Vellore or NIB Noida).

C. Donor Safety & Management

1. Donor Reaction Rate:

   • Indicator: % of donors experiencing adverse events (Vasovagal syncope, Hematoma, Nerve injury).

   • Target: < 2%.[10]

2. Donor Deferral Rate:

   • Indicator: % of prospective donors rejected during screening.

   • Analysis: Are you rejecting too many due to low Hb? (May indicate anemia prevalence in the community).

3. Voluntary vs. Replacement Donor Ratio:

   • Indicator: % of Voluntary donors (Safest) vs. Replacement (Family) donors.

   • Goal: Move towards 100% Voluntary (NABH/NACO goal).

D. Process Audits & Statutory Compliance[12]

1. Cold Chain Maintenance:

   • Audit: 24x7 temperature graphs for:

     • Blood Bank Refrigerators (2°C to 6°C).

     • Deep Freezers (-30°C to -40°C for FFP).

     • Platelet Agitators (22°C ± 2°C with continuous agitation).

   • Alert: Alarm testing to ensure SMS/Hooter goes off if temp fluctuates.

2. Consent & Documentation:

   • Audit: "Informed Consent for Transfusion" in patient files (Must mention risks of TTI).

   • Audit: Form "F" (Blood Issue Register) and Form "H" (Stock Register) as per Drugs & Cosmetics Act.

3. Issue & Return Policy:

   • Audit: Time limit for returning unused blood. (Generally: If > 30 mins outside fridge, it cannot be taken back).

4. Blood Warmer Usage:

   • Audit: Ensure massive transfusions in OT/Trauma use blood warmers to prevent hypothermia-induced coagulopathy.

E. Staff Competency & Biosafety

1. Proficiency Testing:

   • Academic QA: Technical staff tested annually on "Antibody Screening" (Coombs test) and "Reverse Grouping" interpretation.

2. Biomedical Waste (BMW):

   • Audit: TTI Positive bags must be autoclaved/microwaved before being handed over to the waste agency (Red bag).

Implementation Checklist for Blood Bank Officer

• Daily:

  • Temp Check: Review digital logger data for the night shift.
    Stock Check: Ensure adequate O-Negative and AB-Positive (Universal Plasma) stock.
    QC Check: Check reagent RBCs for hemolysis.

• Monthly:

  • Audit of Transfusion Triggers: Review 10 random files. Was blood ordered when Hb was > 10g/dL? (Inappropriate usage).
    Hemovigilance Report: Submit data to the National Institute of Biologicals (NIB) via the "Haemo-Vigil" software (mandatory for Medical Colleges).

• Quarterly:

  • Calibration: Centrifuges (RPM/Time) and Weighing scales.
    Sterility Check: Culture of blood bags (random 1%) to rule out bacterial contamination.