What are the quality control requirements for blood components such as Leukoreduced Red Blood Cells (RBC), single donor platelets, random donor platelets, granulocytes, and cryoprecipitate?

Blood Component Quality Control Requirements

The quality control requirements for blood components are standardized to ensure safety and efficacy, with specific acceptable limits for each component type.

Leukoreduced Red Blood Cells (RBC)

1. Residual WBC (less than): 5 × 10^6 per unit
   • Leukoreduction filters should reduce white blood cells to below this threshold to prevent febrile non-hemolytic transfusion reactions 1
   • Quality control testing can be performed using flow cytometry or microvolume fluorimetry methods 1
   • Universal leukodepletion has been shown to significantly reduce febrile non-hemolytic transfusion reactions 2

Single Donor Platelets

1. PLT CT (at least): 3 × 10^11 per unit
   • Single donor platelets (apheresis platelets) must contain this minimum platelet count to ensure therapeutic efficacy 3
   • Each apheresis product typically has a volume of approximately 200 mL, though larger products may be produced if the donor center was attempting to collect a larger dose 3

Random Donor Platelets

1. PLT CT (at least): 5.5 × 10^10 per unit
   • Random donor platelets (prepared from whole blood) must meet this minimum threshold 4
   • The median platelet content per individual donation is approximately 6.4 × 10^10, representing a final recovery of 62 ± 10 percent 4

Granulocytes

1. WBC (at least): 1 × 10^10 per unit
   • Granulocyte concentrates must contain this minimum number of white blood cells to be effective for neutropenic patients
   • These components are typically collected through apheresis procedures specifically designed to harvest granulocytes

Cryoprecipitate

1. IU Factor VIII (at least): 80 IU per unit

   • Each unit of cryoprecipitate should contain at least this amount of Factor VIII activity 3
   • The mean FVIII activity in plasma separated from fresh whole blood is approximately 104 ± 25 percent 4

2. mg Fibrinogen (at least): 150 mg per unit

   • Each unit of cryoprecipitate must contain this minimum amount of fibrinogen 3
   • 75% of packs should contain at least 140 mg of fibrinogen, and pooled cryoprecipitate (from five donations) should contain > 700 mg 3

Additional Quality Control Considerations

Storage Requirements

• Red blood cells must be stored at a core temperature of 4 ± 2°C with a maximum storage of 28-35 days (depending on additives) 3
• Platelets must be stored at 20-24°C under constant horizontal agitation for 5-7 days (depending on bacterial detection methods) 3
• Cryoprecipitate must be stored at a core temperature below -25°C for up to 36 months 3

Processing Standards

• All blood components should undergo visual inspection for clumps, clots, and aggregates before release 3
• Quality control testing should be performed on at least 1% of each component type prepared 5
• Leukoreduced components should be tested for residual white blood cell counts to ensure compliance with standards 6

Clinical Implications

• Proper quality control ensures that blood components deliver the expected therapeutic effect
• For pediatric patients, blood components should be prescribed in volume (mL) rather than units 7
• A transfusion of 10 mL/kg of RBC should increase hemoglobin by approximately 20 g/L in pediatric patients 7

Following these quality control requirements helps ensure that blood components meet the necessary standards for transfusion safety and efficacy.