6.2: Setting and maintaining specifications

The wide variability of the source material from which blood components are prepared makes it difficult to set stringent limits. Nevertheless, realistic minimum specifications should be set and complied with.

Concessionary release limits are also set for certain components that are subject to non-destructive quality monitoring, such that components that are excessively out of specification are only used therapeutically under specific circumstances and subject to formal clinical approval (Table 6.1).

All blood components tested and found outside concessionary release limits should have the testing repeated to confirm the original result and the production process should be reviewed as necessary.

Some abnormal results could have implications for the health of the donor and should be reviewed by a Designated Clinical Support Officer. Further samples or referral to an appropriate clinical service may be required for the donors of:

• Red Cells in Additive Solution, Leucocyte Depleted, where the Hct is >0.70
• Platelet components collected by apheresis, where the platelet count is below any lower concessionary release limit
• For Fresh Frozen Plasma, Leucocyte Depleted where the FVIII is <0.3IU/mL

Table 6.1 Concessionary release limits

Blood component	Parameter	LOWER Limit (less than)	UPPER Limit (more than)
Red Cells in Additive Solution, Leucocyte Depleted	Haemoglobin (g/unit)	30	None
	Volume (mL)	210	375
	Haematocrit (L/L)	0.40	0.70
Red Cells, Washed, Leucocyte Depleted	Haemoglobin (g/unit)	30	None
	Volume (mL)	210	375
	Haematocrit (L/L)	0.40	0.70
	Residual Protein (g/unit)	None	0.50
Red Cells for Intrauterine Transfusion, Leucocyte Depleted	Haemoglobin (g/unit)	40	None
	Volume (mL)	150	350
	Haematocrit (L/L)	0.70	0.85
Red Cells for Exchange Transfusion (not Whole Blood), Leucocyte Depleted	Haemoglobin (g/unit)	40	None
	Volume (mL)	220	420
	Haematocrit (L/L)	0.50	0.60
Red Cells in Additive Solution for Neonates and Infants, Leucocyte Depleted	Haemoglobin (g/unit)	30/no. of splits manufactured	None
	Haematocrit (L/L)	0.40	0.70
Platelets, Pooled Platelets, Pooled, Buffy Coat Derived, Leucocyte Depleted Platelets, Pooled, Buffy Coat Derived, in Additive Solution and Plasma, Leucocyte Depleted	Platelet Yield (×109/unit)	160	Defined by pack type 1
	Volume (mL)	150	380
Platelets, Apheresis, Leucocyte Depleted	Platelet Yield (×109/unit)	160	Defined by pack type 1
	Volume (mL)	150	380
Platelets in Additive Solution, Leucocyte Depleted	Platelet Yield (×109/unit)	160	Defined by pack type 1
Platelets for Intrauterine Transfusion, Leucocyte Depleted	Volume (mL)	50	120
	WBC (×106/unit)	None	2.5
Platelets, Neonatal Use, Leucocyte Depleted	Platelet Yield (×109/unit)	40	Defined by pack type 1
	Volume (mL)	30	95
Platelets in Plasma and Additive Solution for Neonatal Use, Leucocyte Depleted	Platelet Yield (×109/unit)	40	Defined by pack type 1
Fresh Frozen Plasma, Leucocyte Depleted	Volume (mL)	200	340
	Factor VIII (IU/mL)	0.3	None
	Residual Platelet Count (×109/L), pre-freeze in starting component	None	100
Fresh Frozen Plasma, Pathogen Reduced, Leucocyte Depleted	Residual Platelet Count (×109/L), pre-freeze in starting component	None	100
Fresh Frozen Plasma for Neonates and Infants, Leucocyte Depleted	Factor VIII (IU/mL)	0.3	None
	Residual Platelet Count (×109/L), pre-freeze in starting component	None	100
1 Upper concessionary release limit where stated by manufacturer of platelet pack.

 

Component and process quality monitoring results should be subjected to statistical analysis so that trends can be identified. Guidance on appropriate approaches to statistical process monitoring is given in the Council of Europe guide,¹ and in Beckman et al. (2009).² A flowchart adapted from Beckman et al., to aid in selection of appropriate methods, is reproduced as Figure 6.1.