Performances and determinants of proficiency testing in clinical laboratory services at comprehensive specialized hospitals, northwest Ethiopia.

Proficiency testing (PT) is an impartial laboratory performance-evaluating system using an independent body. It is a mandatory accreditation requirement and means for improving the laboratory's performance. The study aimed to evaluate the performance of PT, with a focus on identifying and discussing determinants that influence PT performance at comprehensive specialized hospitals in northwest Ethiopia. A retrospective cross-sectional study was carried out from 2020 to 2022. Using a convenient sampling technique, laboratory tests with recorded PT results in each hospital laboratory were included. A data collection template and customized checklists were used to collect the data. Epi Data Version 3.1 for data entry and STATA Version 14.1 for cleaning and analysis were used. Binary logistic regression analyses were used. Variables with p < 0.05 in the multivariable logistic regression were considered to be statistically significant. Over nine cycles, 3807 PT challenges were distributed. The total failure rate of the laboratories was 32.4%, with a peak failure rate of 40.3% in 2020, after which the failure rate was decline to 20.6% in 2022. Among the five laboratory sections, molecular biology had the lowest failure rate (22.2%), while microbiology had the highest failure rate (56.5%). Multivariate logistic regression revealed that PT results reported without appropriate unit of measurement (AOR 7.5), lack of corrective action for PT nonconformance (AOR 7.1), and reagent unavailability (AOR 6.1) had significant effects on PT performance (p < 0.001). The results of this study showed that the overall performance of the laboratory was lower. Reporting PT results without appropriate units of measurement and not taking corrective action for PT nonconformance were the major aggravating factors for high failure rates.

Navigating Quality Assessment Hurdles in Clinical Laboratory Services: A Comprehensive Review in Resource-Limited Settings.

External quality assessment is the process of evaluating the performance of a laboratory and the competence of professionals. Participation in EQA and standardizing the quality of laboratory services are a mandatory requirements for accreditation. This review is aimed at identifying and discussing challenges that hinder the effective implementation of an EQA program in countries with resource limited setting. To obtain abundant information, articles were identified by searching the literature publishedin English using the National Library of Medicine, PubMed, Science Direct and AMC digital library databases. The articles identified in the references were manually searched and included. After the article was identified, it was imported to Endnote version 8.1 and exported to Microsoft Word for citation. Based on this review, the major identified challenges that hinder the implementation of an EQA program include the high cost of control materials, malfunction and lack of maintenance for equipment failure and breakdown, a knowledge gap among laboratory professionals, noncommutability of control samples, and difficulty in assigning target values. In addition, failing to participate in EQA and failing to take corrective action are the major challenges identified. As a result, applying to an EQA program in resource-limited counties was highly challenging. To attain high performance in the laboratory and to provide quality laboratory service for patient care, the EQA supplier and the user laboratory must pay attention to these issues and take appropriate corrective actions for ongoing quality improvement and accreditation.

Assessment of hematology laboratory performance in the total testing process using quality indicators and sigma metrics in the northwest of Ethiopia: A cross-sectional study.

Background and Aims: Assuring laboratory quality by minimizing the magnitude of errors is essential. Therefore, this study aimed to assess hematology laboratory performance in the total testing process using quality indicators and sigma metrics. Methods: A cross-sectional study was conducted from April to June 2022. The study included a total of 13,546 samples. Data on included variables were collected using a checklist. Descriptive statistics were used to present the overall distribution of errors. Binary logistic regression models were applied. Furthermore, using a Sigma scale, the percentage of errors was converted to defects per million opportunities to assess laboratory performance. Finally, the defect per million opportunities was converted to a sigma value using a sigma calculator. Results: Of the 13,546 samples and corresponding requests, the overall error rate was 123,296/474,234 (26%): 93,412/47,234 (19.7%) pre-analytical, 2364/474,234 (0.5%) analytical, and 27,520/474,234 (5.8%) post-analytical. Of the overall errors, 93,412/123,296 (75.8%), 2364/123,296 (1.9%), and 27,520/123,296 (22.3%) were pre-analytical, analytical, and post-analytical errors, respectively. The overall sigma value of the laboratory was 2.2. The sigma values of the pre-analytical, analytical, and post-analytical phases were 2.4, 4.1, and 3.1, respectively. The sample from the inpatient department and collected without adherence to the standard operating procedures (SOPs) had a significantly higher (p < 0.05) rejection rate as compared to the outpatient department and collected with adherence to SOPs, respectively. In addition, an association between prolonged turnaround times and manual recording, inpatient departments, and morning work shifts was observed. Conclusion: The current study found that the overall performance of the laboratory was very poor (less than three sigma). Therefore, the hospital leadership should change the manual system of ordering tests and release of results to a computerized system and give need-based training for all professionals involved in hematology laboratory sample collection and processing.

Assessment of liver function tests of women taking hormonal contraceptives at University of Gondar comprehensive specialized hospital and Family Guidance Association of Gondar (FGAE), 2022; a comparative cross-sectional study.

INTRODUCTION: Hormonal contraceptives are artificial preparations that contain artificial progestins and Ethinylestradiol; these preparations are utilized by women of reproductive age to prevent pregnancy. Roughly a billion women in the world use some form of contraceptive worldwide. Despite the utility of these preparations, they are linked with several adverse effects, including disturbances of liver functionality and integrity. However, previous studies conducted to assess the association between hormonal contraceptive utilization and liver function tests reported conflicting results, and the effects remained a matter of concern. METHODS: The study enrolled a total of 264 participants, who were allocated into two groups. One group of hormonal contraceptive users who use the medication for a minimum of six months: Depot medroxyprogesterone acetate (DMPA), combined oral contraceptives (COC), Norplant, and Implant users and another age-matched non-user control group in a ratio of 1:1. A semi-structured questionnaire was used to collect socio-demographic, behavioral, and clinical data. Five ml serum blood sample was collected for liver function test analysis on a Beckman Coulter Clinical Chemistry analyzer (DXC 700 AU). Independent t-test was used to compare liver function tests of hormonal contraceptive users and non-user controls, whereas ANOVA followed by a Bonferroni post hoc test was used for intra- (between classes of contraceptives) and inter-group (between each class of contraceptives and controls) comparisons and to identify factors associated. RESULTS: Hormonal contraceptive users were observed to have a statistically significant higher mean value of liver enzymes assessed compared to non-user control groups: aspartate aminotransferase (AST) (47.07±14.79 versus 25.92±7.37; p <0.001), alanine aminotransferase (ALT) (35.83±13.76 versus 16.56 ± 5.03; p <0.001), alkaline phosphatase (ALP) (63.34±14.74 versus 45.41±14.34, p <0.001) and for γ-glutamyl transferase (GGT) (47.37±24.32 versus 19.45 ± 6.86 p <0.001). Similarly, the mean value of total and direct bilirubin (mg/dL) among HC users showed a statistically significant elevation (0.68 ± 0.22 against 0.32 ± 0.13, p <0.001) for total bilirubin and (0.14 ± 0.06 against 0.06 ± 0.03, p <0.001) for direct bilirubin respectively. However, no statistically significant result was observed in the mean values of total protein and albumin. For total protein (6.7 ± 0.89 versus 6.5 ± 1.15, p 0.07) and for albumin (5.4 ± 0.92 versus 5.3 ± 1.08; p 0.30). The current study also indicates the level of hepatic function test alteration is related to the type of hormonal contraceptives, duration of usage, and level of adherence to a specific class of contraceptives. CONCLUSION AND RECOMMENDATION: Hormonal contraceptive use was observed to affect hepatic function. Based on this finding, we strongly recommend to closely monitor liver function tests in women using hormonal contraceptives.

Assessment of Electrolyte Imbalance and Associated Factors Among Adult Diabetic Patients Attending the University of Gondar Comprehensive Specialized Hospital, Ethiopia: A Comparative Cross-Sectional Study.

Introduction: Electrolyte imbalance refers to altered electrolyte levels that predominantly affect diabetic patients due to hyperglycemia which rise plasma osmolality and impaired renal function, contributing to a change in electrolyte level. Therefore, this study aimed to assess the prevalence of electrolyte imbalance and its associated factors among diabetic patients and healthy control groups attending the University of Gondar Comprehensive Specialized Hospital. Patients and Methods: A comparative cross-sectional study was conducted on 130 diabetic patients and 130 diabetes-free controls. Sociodemographic, behavioral and clinical data were collected using a structured questionnaire. After measuring anthropometric parameters, 5mL of the blood sample was collected. Electrolytes were measured based on ion-selective electrode methods. Fasting blood glucose, and creatinine were measured by spectrophotometric enzyme hexokinase, and Jaffe reaction methods, respectively. The data was entered into Epi-data version 4.6 and analyzed using STATA version 14. Mann-Whitney U-tests and independent t-tests were used for comparison. Multiple logistic regression analysis was done to determine the factors associated with electrolyte imbalances. P-value <0.05 was considered statistically significant. Result: The overall prevalence of electrolyte imbalance among diabetic patients and controls were 83.07% and 52.31%, respectively. The mean of Na+ and the median level of Mg2+ and Ca2+ were significantly decreased. However, the mean level of Cl- was significantly increased in diabetic patients as compared to control groups. In multivariable logistic regression: alcohol consumption AOR = 3.34 [1.02-10.9], no formal education AOR = 5.38 [1.14-25.4], hyperglycemia AOR = 6.32 [2.04-19.5], and urbanization AOR = 5.6 [1.44-22.3] showed significant association with electrolyte imbalance. Conclusion: Diabetic patients have more likely to develop electrolyte imbalance than control groups. Diabetic participants showed significantly reduced Na+, Mg2+, and Ca2+ levels and significantly increasing CI- levels when compared to control groups. Hyperglycemia, alcohol drinking habits, urbanization, and no-formal education were statistically significantly associated with electrolyte imbalance.

Knowledge and Practices towards Prevention and Early Detection of Chronic Kidney Disease and Associated Factors among Hypertensive Patients in Gondar Town, North West Ethiopia.

BACKGROUND: Chronic kidney disease is a global health problem with serious adverse effects, including kidney failure, cardiovascular disease, and premature death. Improving awareness and practice on the impact, prevention, and early detection of chronic kidney disease will reduce the significant economic and public health burden. METHODS: A cross-sectional study was conducted to determine knowledge and practice towards prevention and early detection of chronic kidney disease and its associated factors among hypertensive patients in Gondar town in 2019. The study included hypertensive patients visiting health institutions from February to March 2019. Data was collected using a semistructured questionnaire and individuals who fulfilled our inclusion criteria were selected using a systemic random sampling technique. Epi Info software version 7 was used for data entry, and SPSS version 20 was used for descriptive and logistic regression analysis. RESULT: Out of a total of 442 participants, 434 completed the questionnaire, with a response rate of 98.1%. Of the total, 298 (68.7%) had good knowledge of chronic kidney disease with a mean knowledge score of 8.78 ± 2.80 and 210 (48.4%) had good practice with mean practice score of 6.58 ± 1.61. Educational status, residence, and duration of hypertension were significantly associated with the knowledge and practice scores of the participants in the multivariate logistic regression analysis. CONCLUSION: More than half of the participants had good knowledge about chronic kidney disease and its risk factors. However, the level of preventive practice among participants was low. The educational status, residence, and duration of hypertension were significantly associated variables with knowledge and practice scores in multivariate logistic regression.