Browsing by Author "Mutie, Charles Kyalo"

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    Determination of the Accuracy of Quantitative Measurement Methods in the Clinical Chemistry Laboratory at Machakos Level V Hospital, Kenya
    (International Journal of Current Aspects, 2023) Mutie, Charles Kyalo; Mathenge, Scholastica Gatwiri; Warutere, Peterson
    Accuracy is the extent to which measurements are closely related to the actual values of the analyte. Accuracy is one of the key requirements in Laboratory method verification. Verification is a method of ensuring that tests are carried out per the manufacturer's specifications when tested by laboratory staff and patients at the facility. Other elements of verification include precision, linearity verified with reportable range, uncertainty of measurement, carry-over studies, reference ranges and limit of detection. This study aims to determine the accuracy of the quantitative measurement methods in the Clinical Chemistry laboratory in the month of January 2023. It also provides an alternative method for meeting accreditation requirements on accuracy by medical laboratories seeking accreditation in farstretched laboratories where interlaboratory comparison may not be feasible. A systematic review and meta-analysis at Machakos County, Kenya. The procedure involved analysing commercially available internal quality control material five (5) times a day for eight (8) days bearing the same lot number. Roche Diagnostics, Mannheim, Germany supplied all the reagents, internal quality control materials and calibrators. Accuracy was determined using Roche Cobas® Intergra 400 Clinical Chemistry analyser to perform a comparative descriptive analysis of albumin, alanine aminotransferase (ALT), alkaline phosphatase (Alk Phos), aspartate aminotransferase (AST), chloride, creatinine, Direct Bilirubin (D. Bil), Gammaglutamyl transferase (GGT), potassium, sodium, total bilirubin, total protein, and urea. The study followed guidelines issued by the Clinical Laboratory Improvements Amendment 1988 (CLIA) and Clinical Laboratory Standards Institute (2014). Data analysis was carried out using Excel Windows 10 MS Office 2021. Mean, standard deviation (SD), Z-score, bias %, coefficient of variation (CV) %, and total error allowable (Tea) were calculated from the results of measurement of the analytes. All the analytes achieved a mean which fell within the manufacturer verification interval and hence passed. The bias % score for the analytes was as follows 5 analytes level (19.2%) scored 0 - ±1, 10 analytes level (38.5%) scored ±1.1 - ±2, 7 analytes level (26.9%) ±2.1 - ±3 and 4 analytes level (15.4%) scored above ±3. All analytes were found to have an excellent Z-score performance between 0 to ± 1.96. The total error allowable was found to fall within CLIA and CLSI specifications limits except for chloride PCC1/ Normal control which failed at 5.82% (CLIA target being ± 5%). Analytes' mean was expected to fall within the given manufacturer's mean. The bias % for the analytes which was at zero or near ± zero was considered an excellent score the further away the score was, the poorer the performance. The Z-score was also calculated to establish how far the observed mean fell from the target mean. All analytes were found to have an excellent Z-score performance between 0 to ± 1.96. A Z-score of ± 1.96 to ± 2.57 indicates good performance while a Z-score of over ± 2.58 indicates failed performance. These good results are attributable to the fact that analysis was carried out within a very short duration by the same person, on the state-of-the-art instrument, in a well-controlled environment hence no room for analytical variation. Chloride being an electrolyte failed since it is physiologically controlled in a strict and narrow range.
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    Method Verification and Quality Assurance of Quantitative Analytical Methods in Clinical Chemistry Department, Machakos Level V Hospital, Machakos County, Kenya.
    (Kenyatta University, 2024-04) Mutie, Charles Kyalo
    Kenya seeks greater accreditation of medical labs for accurate results and mutual recognition. Quality management systems and competence are essential in public health laboratories. Machakos Level V hospital laboratory is accredited to ISO 15189:2012. Accreditation leads to accurate and mutual recognition of test results. The facility has state of the art equipment found in other leading hospital laboratories worldwide and several publications on performances. Accreditation requires method validation and verification studies. No guidelines exist for verifying methods at set intervals, which is crucial for providing quality healthcare. Verification and quality assurance of analytical methods follow standard procedures to improve accuracy, patient safety, and lab efficiency. This study aimed to improve the frequency of method verification in the Clinical Chemistry department at Machakos level V Hospital by analysing accuracy, precision, and quality assurance. Test methods were assessed for accuracy, precision, and quality assurance using quality control material. Precision and accuracy were measured and compared to the manufacturer's ranges. Samples were processed on time and External Quality Assurance results were analysed for enhancement opportunities. External Quality Assurance score goal was 80%. Failure to achieve it led to a nonconformance event that necessitated root cause analysis and corrective action. Analysis was conducted on 13 chemistry analytes at Machakos Level V Hospital Laboratory in Kenya. Results were based on internal quality control data. On short term precision twenty-five out of twenty-six analytes met the Clinical Laboratory Improvement Amendments target coefficient of variation %, except for chloride normal control. Fifteen out of twenty-six analytes met manufacturers recommended coefficient of variation % while eleven failed. Parameters that failed include aspartate aminotransaminase, direct bilirubin, total bilirubin, chloride, potassium, sodium, total protein, and urea. Long term precision results revealed twenty analytes level met target Coefficient of Variation %, but three failed both controls that is chloride, potassium, and urea. None of the thirteen analytes met manufacturers recommended coefficient of variation % hence failure. All the analytes passed accuracy with a mean within manufacturer's verification interval and Z-score of less than ±1.96. Results were consistent with manufacturer recommendations for all analytes indicating no statistical difference. Total error was calculated based on Clinical Laboratory Improvement Amendments guidelines. All analytes passed except chloride normal control. On quality assurance, a retrospective analysis on thirteen general chemistry analytes spanning August 2021 to February 2023 was conducted. Review of internal quality control found violations of Westgard rules, inconsistent and insufficient reviews by the laboratory, they reviewed three out of twelve months. Data on performance from European Society for External Quality assessment was utilized. Passes were achieved in November 2022, August 2022, and March 2022 cycles, indicating consistent improvement. Failure was recorded in May 2022, November 2021, and August 2021. Results were shared with management for corrective action and preventive action. The findings will aid other counties, accreditation bodies and the Ministry of Health in refining policies crucial for laboratory accreditation.