Evaluating proficiency testing implementation and identifying challenges that government comprehensive specialized hospital laboratories in northwest Ethiopia faced as they participated in the external quality assessment scheme: A document-based, interview-driven evaluation.

OBJECTIVES: To assess the implementation of proficiency testing in the northwest Ethiopian government comprehensive specialized hospital laboratories, with a focus on identifying and understanding the challenges encountered during their participation in the external quality assessment scheme. METHODS: A cross-sectional study was conducted among 3 comprehensive specialized hospitals in northwest Ethiopia, analyzing 41 documented laboratory test parameters from 2020 to 2022. In addition, face-to-face, in-depth interviews were carried out to identify the major challenges the participating institutions faced. RESULTS: The study covered a total of 41 tests across 9 cycles. Overall, proper implementation of proficiency testing was observed in 59.3% of the tests, with 61.8% maintaining consistent implementation status over 3 consecutive years. In addition, the overall performance of the laboratory was 54.3%, with a 68.7% participation rate. The predominantly identified challenges included the lack of participation, insufficient reagents and supplies, inadequacy of suitable proficiency testing materials, equipment malfunction and downtime, lack of management support, insufficient budget, and inadequate training and awareness. CONCLUSIONS: The results of this study highlight the ineffective implementation of proficiency testing. Contributing factors include personnel issues, equipment and supplies challenges, managerial shortcomings, difficulties with proficiency testing providers, budgetary constraints, and a lack of training and motivation.

Exploring coagulation parameters as predictive biomarkers of Plasmodium infection: A comprehensive analysis of coagulation parameters.

BACKGROUND: Malaria affects the intravascular environment, leading to abnormal coagulation activation, prolonged prothrombin time, and activated partial thromboplastin time. Despite the high prevalence of malaria in the study area, there has been little published research on the effects of Plasmodium infection on coagulation parameters. OBJECTIVE: The aim was to assess the effect of malaria on basic coagulation parameters among patients attending Dembia Primary Hospital and Makisegnit Health Center. METHODS: A cross-sectional study was carried out from January to March 2020. The study involved 120 participants. Blood specimens were collected, which were analyzed using a Huma Clot Due Plus analyzer. The collected data were entered into EpiData and exported to SPSS version 21 for analysis. Non-parametric statistical methods were employed to analyze the data. The results were considered statistically significant if the p-value was less than 0.05. RESULTS: Individuals infected with Plasmodium exhibit coagulation disorders with elevated levels of PT (Prothrombin Time), APTT (Activated Partial Thromboplastin Time), and INR (International Normalization Ratio) in comparison to healthy controls. The median PT, APTT, and INR values for infected cases were measured at 20.5 [8.6], 39.5 [17.9], and 1.8 [0.9], respectively, while healthy controls had measurements of 15.1 [2.5], 28.8 [8.3], and 1.3 [0.2] (p ≤ 0.001). The severity of coagulation disorders increased with an increase in parasitemia levels. The type of Plasmodium species present had a significant impact on PT and INR values (p ≤ 0.001), whereas APTT did not show any significant impact across the Plasmodium species (p > 0.05). CONCLUSION: The results of this study found that malaria has a substantial impact on various blood clotting parameters, including PT, APTT, and INR. Parasitemia severity is significantly associated with extended PT and INR, implying that the higher the parasitemia, the longer it takes for blood to clot. Furthermore, the study discovered that the PT and INR levels differed based on the type of Plasmodium species responsible for the infection.

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.

Analyzing clinical laboratory specimen rejection rates at a specialized hospital in Ethiopia: A 2-year document review.

OBJECTIVES: Accurate laboratory diagnosis is essential for effective patient care, but the rejection of specimens within laboratories can have serious consequences. METHODS: A retrospective cross-sectional study was conducted from September to November 2021 at the University of Gondar Comprehensive Specialized Hospital laboratory. Two years of laboratory data were collected from laboratory log books and analyzed to determine trends in specimen rejection rates and identify potential reasons for those rejections. RESULTS: We analyzed 114,439 specimens, of which 786 (0.70%) were rejected. The hematology service exhibited the highest rejection rate, at 273 (0.2%). The main reasons for specimen rejection were specimens without requests or requests without specimens (40.2%), poor smear preparation (12.3%), clotted specimens (11.3%), and labeling problems (8.0%). CONCLUSIONS: This study emphasized a significant incidence of specimen rejection, particularly in the hematology laboratory, underscoring the need for immediate implementation of corrective actions and preventive measures. Furthermore, conducting comprehensive larger-scale studies is recommended to deepen our understanding of and investigate the specific factors contributing to specimen rejection in greater detail.

Seroprevalence of Hepatitis C Viral Infection in Ethiopia: A Systematic Review and Meta-Analysis.

BACKGROUND: Hepatitis C virus is a highly genetically heterogenous bloodborne pathogen that is responsible for acute and chronic hepatitis. Globally, an estimated 71 million population is chronically infected with this virus from which 399,000 people die every year. Its prevalence is high in Ethiopia and varies from region to region, even among different studies within a region. METHODS: Electronic databases, including Science Direct, Medline, HINARI, African Journals Online, TRIP database, African Index Medicus, and Directory of Open Access Journals, searched from 2010 to 2020 and published articles were included. Due to evidence of considerable heterogeneity, the pooled prevalence of anti-HCV was analyzed using the random-effects model. The possible sources of heterogeneity were analyzed through subgroup analysis, sensitivity analysis, and meta-regression. Funnel plots and Egger's test statistics were used to determine the presence of publication bias. RESULTS: The analysis of 56 articles showed that the prevalence of anti-HCV in Ethiopia ranged from 0% to 22%. The pooled prevalence estimated was 2% (95% CI 2.0-3.0), and the meta-regression statistics indicated that the diagnostic method (p=0.037), study group (p=0.005), and level of bias (p=0.035) showed statistically significant association with the outcome variable. The sensitivity analysis claims no influence on the overall effect estimate while removing a single study from the analysis at a time. Egger's test statistics (p ≤ 0.001) declare the presence of publication bias that is handled using time and fill analysis. CONCLUSIONS: The pooled prevalence of anti-HCV in Ethiopia was high. Predictor variables, including the diagnostic method, study group, and level of bias, showed a statistically significant relationship with the outcome variable. Strengthening the scope of existing prevention and control programs and implementing novel approaches, including screen-and-treat, could significantly help to tackle this critical public health issue. The study provides a current estimate which is valuable for policymakers and other responsible bodies.

Prevalence of Cryptococcal Antigenemia and Associated Factors among HIV/AIDS Patients at Felege-Hiwot Referral Hospital, Bahir Dar, Northwest Ethiopia.

BACKGROUND: Cryptococcosis is the most common opportunistic fungal infection. High morbidity and mortality are frequently observed among hospitalized HIV/AIDS patients, particularly having CD4 count ≤100 cells/µl. Therefore, this study aimed to determine the prevalence of cryptococcal antigenemia and associated factors among HIV/AIDS patients. METHODS: A hospital-based cross-sectional study was conducted among 140 HIV/AIDS patients. A cryptococcal antigen test was performed for all patients along with medical chart and laboratory registration book review. Cryptococcal antigen was detected from serum by using Remel Cryptococcal Antigen Test Kit. Data related to possible associated factors were extracted from patients' charts and laboratory registration book. Data were coded, entered, and analyzed using SPSS version 20. Logistic regression analysis was done to see the association between dependent and independent variables. A P value <0.05 was considered statistically significant. Finally, data were presented in the form of texts, figures, and tables. RESULT: Among 140 serum cryptococcal antigenemia-tested study subjects, 16 (11.43%) were positive for serum cryptococcal antigen. Of them, 43.8% (7/16) were pulmonary tuberculosis coinfected, 31.2% (5/16) were extrapulmonary tuberculosis positive, and 25% (4/16) had bacterial bloodstream infections. In addition, 68.7% (11/16) had CD4 count less than 100 cells/µl, 18.7% (3/16) had CD4 count 100-150 cells/µl, 50% (8/16) were antiretroviral therapy defaulters, and 31.3% (5/16) were naïve. In this study, the majority, 75% (12/16), of the serum cryptococcal antigen-positive subjects were clinical stage IV. Of the assessed associated factors, tuberculosis coinfection (AOR: 0.04; 95% CI [0.005-0.25]) and antiretroviral therapy status (AOR: 0.02; 95% CI [0.001-0.5]) were significantly associated factors enhancing serum cryptococcal antigenemia. CONCLUSION: In this study, the high rate of cryptococcal antigenemia was observed among hospitalized HIV/AIDS patients, and it is alarming and highlights the need for improving CD4 status, expanding serum cryptococcal antigen screening, and strengthening regular cryptococcal antigenemia surveillance systems.

Antimicrobial Resistance Patterns of Bacterial Isolates from Blood Culture among HIV/AIDS Patients at Felege Hiwot Referral Hospital, Northwest Ethiopia.

BACKGROUND: The emergence and spread of antimicrobial resistance in bacteria is recognized as a global public health problem. Bloodstream infection with antimicrobial-resistant bacteria in HIV/AIDS patients makes the problem more challenging. So, regular and periodic diagnosis and use of the appropriate antimicrobial susceptibility pattern determination is the only option for decreasing the prevalence and development of drug-resistant bacteria. METHODS: An institution-based cross-sectional study was conducted among 384 HIV/AIDS patients. Sociodemographic data of patients were recorded using structured questionnaires. Blood cultures were collected with BACTEC aerobic blood culture bottles. A pair of samples was collected from each patient aseptically and incubated at 37°. If samples are positive for bacterial agents, they were subcultured to solid media such as blood agar plate, chocolate agar plate, and MacConkey agar plates. Identification was performed using colony characteristics and standard biochemical techniques. The antimicrobial susceptibility test was determined by the Kirby-Bauer disc diffusion method. Data entry and analysis were performed while using SPSS version 20. Descriptive statistics were performed to calculate frequencies. RESULTS: Altogether, 384 patients were included, and 123 blood cultures were positive, so that the yield was thus 32%. About 46 (37.4%) of Gram-negative and 77 (62.6%) of Gram-positive bacterial species were identified. Among Gram-negative bacterial isolates, K. pneumoniae was the leading pathogen, 19 (41.3%), whereas S. aureus, 38 (49.4%), was predominant among Gram-positive isolates. In his study, the majority of Gram-positive isolates showed high level of resistance to penicillin, 72 (95.5%), tetracycline, 55 (71.4%), and cotrimoxazole, 45 (58.4%). About 28 (73.6%) of S. aureus isolates were also methicillin-resistant. Gram-negative bacterial isolates also showed a high resistance to ampicillin (91.3%), tetracycline (91.3%), and gentamicin (47.8%). Overall, about 78% of multidrug resistance was observed. CONCLUSION: Several pathogens were resistant to greater than five antimicrobial agents, so that proper management of patients with bacteremia is needed, and a careful selection of effective antibiotics should be practiced.

Laboratory Quality Management System and Quality Indicators Implementation Status as Perceived by Laboratory Professionals in Preparation for the Accreditation Process from Selected Government Hospitals of Ethiopia.

BACKGROUND: The aim was to produce quality results that clinical laboratories need to implement and maintain continuous quality improvement systems. In recent years, health organizations have increasingly prioritized the quality of laboratory services by implementing quality management systems (QMSs) and building quality improvement activities. Efforts to strengthen laboratory systems in the African region have received increased attention in recent years. Assessing the implementation levels of laboratory quality management system components is important to identify the gaps that need further improvements. METHODS: A cross-sectional study design was used between March and May 2017 in selected government hospitals of Ethiopia, and sample size was determined using a finite population formula, and a proportional sampling technique was employed; a sample size of 184 (62%) was calculated from 295 laboratory professionals. RESULTS: All respondents were informed about the laboratory's experience in the quality management system implementation; of those, only 138 (79%) engaged in the implementation process. From the 18 selected laboratory quality management components, 5 were observed to have the list implementation status, which are: (1) Performance of internal quality control for all tests, (2) Development and communication of a quality manual for all tests, (3) Adequacy of storage space for the supplies, (4) Development of an action plan based on internal audit, and (5) monitoring of environmental conditions. Running quality controls for all types of tests became a headache in almost all laboratories. From 12 selected quality indicators studied in this research, the 5 indicators with either poor or very poor performance outcome were: control of documents 136 (77.7%), control of records 123 (70.3%), development of manuals and policies 122 (69.7%), development of process and procedures 120 (68.6%), and internal communication 114 (65.1%). CONCLUSIONS: This research indicated the top 3 LQMS components with either poor or very poor implementation status: (1) Performance of internal quality controls for all tests, (2) Development and communication of quality manuals for all tests, (3) Adequacy of storage space for the supplies. Of the quality indicators studied, control of documents was perceived to have poor performance outcome by 136 (77.7%) of study participants.

How Does ISO 15189 Laboratory Accreditation Support the Delivery of Healthcare in Ethiopia? A Systematic Review.

BACKGROUND: Assessing quality by considering input, process and output level quality variables is important to ensure improved quality services. Designing and execution of an effective quality management system are aimed for the purpose of quality improvement, error reduction and associated risks. Therefore, this review is designed to assess the value of accreditation on the performance of healthcare institutions in ensuring quality improvement interventions. Moreover, this review presents important concepts of accreditation and the aspects of quality. METHODS: Published articles were downloaded using EndNote® application software program from PubMed (NML) database, Web of Sciences (TS) and Google Scholar. From a total of 883 downloaded full-text published materials, only 28 journals and 1 report issued from 2010 to 2017 were used for the development of this review. RESULT: The overall quality of healthcare services in developing countries was error-prone and suffered from limitations. These could be associated with wrong interventions and increased risks. Accreditation schemes have been implemented to provide quality care and ensure safety. CONCLUSION: Evaluation feedback induces interventions aimed at quality improvement and ensures better management systems, good process design, wise resource utilization, meeting patients' need and increased satisfaction. Hence, stakeholders must be engaged in the provision of improve quality patient care and reduce associated risks. Hence, giving special quality improvement attention helps to improve quality healthcare services.

Knowledge, attitude, and practice of waste handlers about medical waste management in Debre Markos town healthcare facilities, northwest Ethiopia.

OBJECTIVE: Medical waste is a total waste stream which is generated from the healthcare facilities during the healthcare delivery process. It can contain potentially hazardous substances for the human being and the environment. Waste handlers play a significant role for its proper management and they need to have adequate knowledge, attitude, and practices. The study aimed to evaluate the knowledge, attitude, and practices of waste handlers regarding medical waste management in Debre Markos town healthcare facilities, northwest Ethiopia. RESULTS: A total of 55 medical waste handlers were studied from 12 healthcare facilities. Among this, 25 (45.4%) were diploma and certificate holders. The majority (69.1%) of the study participants were not provided with proper training. There was a lack of personal protective devices and waste management equipment supply. Regarding knowledge, attitude, and practices, 25 (45.5%), 43 (78.2%), and 44 (80%) of the study participants had adequate knowledge, favorable attitude, and adequate practice scores, respectively. There was high (30.9%) prevalence of needlestick and sharps injuries. Healthcare facilities should provide periodic training and adequate supplies for the waste handlers. Further study should be conducted on a large scale by including different levels of health facilities and regions of the country.

Plasmodium falciparum and Plasmodium vivax Prevalence in Ethiopia: A Systematic Review and Meta-Analysis.

BACKGROUND: Malaria is a protozoan disease caused by the Plasmodium species. Among the five Plasmodium species. Among the five Plasmodium falciparum and Plasmodium vivax malaria are by far the most predominant and widely distributed in Ethiopia. Malaria is one of the leading causes of morbidity and mortality globally, particularly in the sub-Saharan countries including Ethiopia. It is also a major obstacle to socio-economic development in the country. METHODS: Articles were searched from PubMed, Google Scholar, and Science Direct databases. The pooled prevalence estimates were analyzed using the DerSimonian-Laird random-effects model and the possible sources of heterogeneity were evaluated through subgroup analysis, metaregression, and sensitivity analysis. Publication bias was analyzed using funnel plots and Egger's test statistics. The data management and analysis were done using STATA 15.1 version software. RESULTS: Among 922 studies initially identified, thirty-five full-text articles fulfilled the inclusion criteria and included in the study. The combined, Plasmodium falciparum and Plasmodium vivax malaria are by far the most predominant and widely. CONCLUSIONS: This systematic review and meta-analysis showed a high malaria prevalence in Ethiopia. Therefore, previous prevention and control measures should be revised and/or strengthened as appropriate and new strategies should be implemented. In addition, technical, financial and material support, and coordination of the regional capacity building and logistics should be adequately implemented.

How does ISO 15189 laboratory accreditation support the delivery of healthcare in Ethiopia? a systematic review

BACKGROUND: Assessing quality by considering input, process and output level quality variables is important to ensure improved quality services. Designing and execution of an effective quality management system are aimed for the purpose of quality improvement, error reduction and associated risks. Therefore, this review is designed to assess the value of accreditation on the performance of healthcare institutions in ensuring quality improvement interventions. Moreover, this review presents important concepts of accreditation and the aspects of quality. METHODS: Published articles were downloaded using EndNote® application software program from PubMed (NML) database, Web of Sciences (TS) and Google Scholar. From a total of 883 downloaded full-text published materials, only 28 journals and 1 report issued from 2010 to 2017 were used for the development of this review. RESULT: The overall quality of healthcare services in developing countries was error-prone and suffered from limitations. These could be associated with wrong interventions and increased risks. Accreditation schemes have been implemented to provide quality care and ensure safety. CONCLUSION: Evaluation feedback induces interventions aimed at quality improvement and ensures better management systems, good process design, wise resource utilization, meeting patients' need and increased satisfaction. Hence, stakeholders must be engaged in the provision of improve quality patient care and reduce associated risks. Hence, giving special quality improvement attention helps to improve quality healthcare services

Assessment of Knowledge, Attitude, and Practice about Biomedical Waste Management and Associated Factors among the Healthcare Professionals at Debre Markos Town Healthcare Facilities, Northwest Ethiopia.

Background: Healthcare activities restore health and save lives at the same time; however, they can generate hazardous biomedical wastes to a human being or the environment. Generation and disposal of biomedical wastes have become an emerging problem worldwide. Objective: To assess knowledge, attitude, and practice about biomedical waste management and associated factors among healthcare professionals in Debre Markos town healthcare facilities, northwest Ethiopia. Methods: A cross-sectional study was employed, and data were collected through structured self-administered questionnaire and observational checklist. Data were entered into the Epi-data 3.1 software and exported into SPSS version 20 for analysis. Bivariate and multivariate logistic regression analyses were computed. Variables with a P value of <0.05 in the multivariate logistic regression analysis were considered to explain the presence of statistically significant associations. Result: Among 296 healthcare professionals studied, 168 (56.8%), 196 (66.2%), and 229 (77.4%) had adequate knowledge, favorable attitude, and adequate practice score, respectively. Regarding associated factors, MSc and MD+ (AOR: 4, 95% CI: (1.37, 149.52)), BSc holders (AOR: 2.53, 95% CI: (1.47, 4.38)), and availability of color-coded bins (AOR: 7.68, 95% CI: (3.30, 17.89)) were identified more likely to contribute for adequate knowledge, favorable attitude, and adequate practice scores, respectively. Conclusion: The level of knowledge, attitude, and practice scores were not satisfactory. Majority of the healthcare professionals did not access biomedical waste management training. Educational level, use of visual aid, and availability of color-coded bins in the department were identified as a factor for biomedical waste management. Regular training should be given to healthcare professionals.