Internal quality control in blood and component bank in a tertiary healthcare center in Northern India

Introduction

Blood Banking is a vital part of the health care service. Increasing advancement in the field of transfusion medicine has been enforcing measures to ensure quality of blood and blood components.^[1] Blood transfusion service (BTS) is the fundamental part of health care system; deficiency causes impractical overall medical management. However, the blood transfusion is not free of risks owing to human factors; thus, it should only be prescribed when patients clinical statuses really necessitate it.^[2] Transfusion services must have a standard obligation to endorse the optimal usage of blood components and to ensure that the final product causes minimal to zero risk to the potential recipient.^[3]

In order to improve the standards of blood banks, well equipped blood centers with infrastructure and man power is an essential requirement. Red Cell Concentrate, Fresh Frozen Plasma, Platelet Concentrate, Cryoprecipitate, Platelet Apheresis are the important components which require quality control. Internal quality control (IQC) is the backbone of the quality management program in the blood bank.^[4], ^[5]

In the modern blood banking, quality controls of blood products ensure the timely availability of a blood component of high quality yield with maximum efficacy and minimal risk to potential recipients. Processes and manuals are needed to be highly focused on generating quality blood components that are more efficacious and safe.^[6]

In recent years, there have been significant developments, aimed at improving the quality of the blood components. There have been advancement and progression in international standards for blood components and principles of high‑quality manufacturing practices have been redefined to provide the framework for quality in BTSs. This drive causes significant improvement in processes and blood component quality.^[2] The purpose of this study is to determine the IQC on various blood products in a tertiary care center.

Materials and Methods

An observational cross sectional study was conducted at the Blood and Component Bank of Jawaharlal Nehru Medical College Hospital from 2018 to 2020. Total units of each blood component was arbitrarily chosen during the study. Packed red cell units were evaluated for hemoglobin, hematocrit, RBC count; platelet concentrates were evaluated for pH, yield and culture; fresh frozen plasma and cryoprecipitates were evaluated for unit volume, factor VIII and fibrinogen concentrations. Monthly Quality control (QC) of the donated blood bags was performed and the selection criteria was 1.0% of the total collection or minimum 4 bags per month.

Observations

Mean volume and hematocrit per unit was 238+26.25ml and 65.75+7.42% respectively and hemoglobin and RBC Count was 20.5+0.15g/dl and 5.89x10¹²+0.30x10¹² respectively^. ([Table 1])

Mean volume, pH and platelet count was 82.5+13.75ml, 6.8+0.175 and 5.7x10¹⁰ respectively for 68 platelet concentrates studied. ([Table 2])

The Mean volume, Factor VIII levels, Fibrinogen concentration, PT and APTT of 76 units was 215+32.5 ml/unit, 95.25+7.37 IU/unit, 307.5+41.375 gm/l,14.15+0.325 sec and 29.50+1.5 sec respectively. ([Table 3])

The Mean volume, Factor VIII levels, Fibrinogen concentration of 76 units was 56+32.5 ml/unit, 99.25+5.37 IU/unit, 217.5+51.37 gm/l respectively. ([Table 4])

Discussion

Blood banks have a dual liability primarily to meet the adequate blood supply for the community and essentially to ensure maximum blood recipient safety. Improved quality testing over the period has resulted in safer transfusion practices and decrease adverse outcomes.^[6] The aim of quality control measures is to ensure supply of safe and efficient blood transfusion to the patient and to prevent transfusion transmitted diseases.

The primary component in the quality control system is blood donation, which is collected from prospective donors of various ages with different demographics, health profiles, and risk behaviors.^[5], ^[7] This blood collection process mainly depends on manual procedures which may have operator variations. Subsequently, these donations are screened, stored, and transported under variant environmental circumstances. These variants may compromise the critical control points which are designed to improve the quality of blood components.^[7], ^[8], ^[9] Our study assessed the mean volume, hematocrit, hemoglobin and RBC count of PRBCs. The mean volume of PRBCs was 238 ml with the range of 185-290ml. Haematocrit was 65.75% with a range of 50.9-80.6%, hemoglobin was 20.5g/dl with a range of 20.3-20.9g/dl and RBC count was 5.89x10¹² /L with a range of 5.29-6.50x10¹²/L. Results similar to our study have been observed by Upadhyay et al in 2016, who found mean volume of PRBCs units as 285±24.3 mL with a range of 198-350 mL and mean haematocrit of 54±4.2% with a range of 41-69%.¹⁰ Singh et al in 2009 found the Mean volume of RBCs as 310 mL with range of 270-390 ml and mean hematocrit as 69.5% with range of 56.3-80.9%.^[10]

Our study also assessed the volume, pH, platelet count and culture of platelet concentrates. Mean volume of platelet was 82.5 ml with a range of 55-110ml, pH was 6.8 with a range of 6.4-7.1, mean platelet count was 5.7x10¹⁰ with a range of 3.4-8x10¹⁰ and all the cultures were sterile. Similar results were observed by Gupta et al, Fijnheer et al and Hirosue et al.^[11], ^[12], ^[13]

Our study also assessed the volume, levels of factor VIII, fibrinogen, PT and APTT. Mean volume of 76 units tested was 215ml with a range of 150-280 ml, mean factor VIII levels were 95.25 with a range of 80.5-110.0% and mean fibrinogen levels were 307.5 mg/dl with a range of 225.0-390.5 mg/dl. PT and APTT had a mean value of 14.15 sec and 29.50 sec respectively. Sultan et al in 2016 tested 100 units for internal quality control. The mean factor VIII and fibrinogen levels were found to be 84.24±15.01 and 247.17±49.69 for FFP respectively. Almost all donors had fibrinogen ≥150mg/dl, while only five percent donors had factor VIII below the desired levels in their study.^[8]

In another study done by Agus et al in 2012, 30 units of FFP prepared within 8 hours of collection were tested for factor VIII levels, who found the mean to be 1.0 IU/mL with a range of 0.66-1.47 IU/mL.^[14] Dogra et al in 2015 also assessed the comparative analysis of Factors V and VIII and fibrinogen in 100 units of Fresh Frozen Plasma and reported the level of fibrinogen as 270.66±69.64 mg/dl and factor VIII as 117.205±29.01%.^[15]

Source of Funding

No financial support was received for the work within this manuscript.

Conflicts of Interest

There are no conflicts of interest.