Risk assessment of auto hematology analyzer operation

Abstract

Auto hematology analyzer is used widely to measure blood cells which known as complete blood count. Its results medically important for interventions so should be analytically valid. Many factors may affect in the result of auto hematology analyzer which lead to un reliable result like pre analytical handling related to sample conditions and sample stability according to store conditions and the instrument used for measurement may affect on the result due to be affected by some factors . The main objective of this study was risk assessment on auto hematology analyzer operation taking into consideration the three indicators of performance which are accuracy, precision and reliability. A crosssectional study was conducted in 30 medical laboratories in the Khartoum state. Fifteenhospitals, one health center five dispensaries and nine special lab were involved the study. Data was collected using questionnaire in addition to check up and evaluation study of instrument in the day of interview. The main variables in the questionnaire were staff competency (sex, age, qualification and experience), staff and supervisor training, operation,routine maintenance, preventive maintenance, QC,calibration, instrument environment, accuracy, precision and reliability.30 medical laboratory specialists were interviewed and 30 instruments were checked and evaluated. Analysis of data was done by using SPSS version 26 using correlation to measures the association between two variables frequency tables and percent were calculated. The results reveal that some environment and personal elements are signifycant effect on the performance of auto hematology analyzer. appropriate environment effects on HGB precision with coefficient of 0.539(p=0.002), adequate temperature effects on HGB, PLT precision with coefficient 0.484(p=.007),0.583(p=0.001)in series and adequate space effects on PLT , HGB precision with coefficient 0.451(p=0.012) and 0.404(p=0.027).in addition to Standard checkeffects on WBC precision with coefficient 0.447(p=0.013),preventive maintenance effectson HGB,HCT accuracy with coefficient 0.456(p=0.011),0.393(p=0.032) in series ,QC effects on RBC precision with coefficient 0.363(p=0.049). It conclude that the instrument environment has effect on the precision of HGB and PLT while some personal elements effect on precision of WBC, RBC, accuracy of HGB and HCT.