Browsing by Author "Abu Bakar Hassan"

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    ANALYTICAL PERFORMANCE OF CLINICAL LABORATORY METHODS: PRACTICAL APPLICATION OF STATISTICAL QUALITY CONTROL AND EVALUATION PROCEDURES
    (2018-12) Mohammed Babikir M. Elbashir; Abu Bakar Hassan; Bakri Yousif Mohamed Noor
    The introduction of new instruments and methodology in medical laboratory necessitates validation studies of accuracy and precision to ensure that the new method is to meet acceptable standards of performance. Evaluation studies will assess the current performance characteristics of instruments under study. Daily quality control procedures represent the primary tool to continuously monitor the performance of laboratory instruments. Most of medical laboratories in Gazira state either totally not implement these practices or partially been implemented. The main cause is the lack of proper training especially at managerial and decision-making levels. The study question is what kind of errors are present plus how much big are those errors. Methodology: The study has been conducted during the period from June to October 2017. Precision and accuracy performance characteristics have been thoroughly evaluated for the chemistry analyzers of three major clinical laboratory entities in Wad Medani, Gezira state, Sudan. Three biochemistry analytes were chosen- urea, glucose and cholesterol. Imprecision assessment was done according to the guidelines protocol of Clinical Laboratory Standards Institute CLSI – EP15-A2 while assessment of inaccuracy was carried out according to CLSI– EP6 guidelines. Administrative approvals were obtained from the Managers of selected facilities. Results: 22 out of 24 imprecision experiments were successfully passed producing 92% pass rate for lab 1. Lab 2 imprecision experiments shown to be acceptable. 24 out of 24 imprecision experiments were successfully passed producing 100% pass rate for lab 2. Unfortunately, 13 out of 24 imprecision experiments were successfully passed producing 54% pass rate for lab 3. 9 out of 17 linearity evaluation and calibration verification results were shown to be successfully verified making a score of 53% for lab 1. 17 out of 18 linearity evaluation and calibration verification results were shown to be successfully verified making a score of 94% for lab 2. Finally, 13 out of 18 linearity evaluation and calibration verification results were shown to be successfully verified making a score of 72% for lab 3. Conclusion: The aim of this project was to fill the gaps which have been found in the process management among the study population by using a practical example. Errors found are mostly related to issues with calibration processes whether some bad materials might have been used or corrupted micropipette might have been involved. Recommendations: Wrong practices like refilling reagents and using any material beyond the stated expiration date may be considered as the major contributor on this dilemma. If the lab ought to use an outdated material, it should be strictly monitored by quality control procedures. The culture of preventive maintenance plays a substantial role in the machine performance, spending money on maintenance training program is far less expensive than fixing repeated problems. The study recommends to take these practices into a large scale covering all laboratories in Wad Medani, Gezira state and to be regulated by the local authorities.