Accreditation of Medical Laboratories

2021 ◽  
pp. 600-616
Author(s):  
Donovan McGrowder ◽  
Dwayne Tucker ◽  
Fabian G. Miller ◽  
Melisa Anderson ◽  
Kurt Antonio Vaz ◽  
...  
Keyword(s):  
Quality Management System ◽  
Clinical Laboratory ◽  
National Laboratory ◽  
Sub Saharan Africa ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Clinical Laboratories ◽  
Resource Limited ◽  
Sub Saharan ◽  
Formal Recognition

Quality test results generated by medical laboratories across the globe are critical for patient diagnosis and treatment. In addition, this is an area of healthcare that requires standardization. Accreditation is the formal recognition by an authoritative body noting that the clinical laboratory has an established quality management system and is competent to carry out specific tasks related to testing. The Strengthening Laboratory Management Toward Accreditation (SLMTA) program was established to strengthen national laboratory systems and to drive improvements that are immediate and measurable in developing countries, particularly those in Sub-Saharan Africa. This review seeks to look at opportunities that can be garnered by accredited medical laboratories and challenges in seeking accreditation during the implementation and operational states of the criteria of ISO 15189:2012. It also examines the progress toward clinical laboratories becoming accredited due to the enactment of the SLMTA in resource-limited settings.

scholarly journals Fanconi–Bickel syndrome in a Ugandan child – diagnostic challenges in resource-limited settings: a case report

2020 ◽  
Vol 14 (1) ◽  
Author(s):  
Thereza Piloya ◽  
Hawa Ssematala ◽  
Lydia Paparu Dramani ◽  
Oliva Nalikka ◽  
Miriam Baluka ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Failure To Thrive ◽  
Autosomal Recessive Disorder ◽  
Initial Presentation ◽  
Sub Saharan Africa ◽  
Black African ◽  
Resource Limited ◽  
High Prevalence ◽  
African Populations ◽  
Sub Saharan

Abstract Background Fanconi–Bickel syndrome is an autosomal recessive disorder of glucose metabolism. It is an extremely rare disorder. Most cases have been reported in consanguineous communities. None of the cases have been reported in Black Africans in sub-Saharan Africa. This case was diagnosed 3 years after initial presentation due to diagnostic challenges and limited awareness of similar metabolic syndromes in our setting. Case presentation We report the case of a 4-year-old boy, born to non-consanguineous Black African parents, who presented with failure to thrive and rachitic features in infancy. Clinical, laboratory, and radiological features were indicative of Fanconi–Bickel syndrome. No genetic testing was done. The diagnosis was made 3 years after the initial presentation due to diagnostic challenges. He showed clinical improvement with the institution of a galactose-free diet. Conclusion Fanconi–Bickel syndrome occurs even in non-consanguineous Black African populations. Therefore, clinicians in resource-poor settings should raise their index of suspicion for such metabolic disorders in settings with a high prevalence of failure to thrive among children.

scholarly journals Building sustainable research capacity at higher learning institutions in Tanzania through mentoring of the Young Research Peers

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Emmanuel Balandya ◽  
Bruno Sunguya ◽  
Daniel W. Gunda ◽  
Benson Kidenya ◽  
Tumaini Nyamhanga ◽  
...  
Keyword(s):  
Undergraduate Students ◽  
Professional Education ◽  
Research Training ◽  
Peer To Peer ◽  
Sub Saharan Africa ◽  
Ongoing Research ◽  
Scientific Presentation ◽  
Resource Limited ◽  
Sub Saharan ◽  
Young Researchers

Abstract Background Sustainability of research culture in Sub-Saharan Africa is threatened in part by the lack of a critical mass of young researchers with the requisite skills and interest to undertake research careers. This paper describes an intensive mentorship programme combining hierarchical (vertical) and peer-to-peer (horizontal) mentoring strategies among young researchers in a resource limited setting in Sub-Saharan Africa. Methods A consortium of three partnering large Tanzanian health training institutions (MUHAS, CUHAS and KCMUCo) and two collaborating US institutions (UCSF and Duke University) was formed as part of the five-year Transforming Health Professions Education in Tanzania (THET) project, funded by the NIH through Health Professional Education Partnership Initiative (HEPI). Within THET, the Community of Young Research Peers (CYRP) was formed, comprising of inter-professional and cross-institutional team of 12 Master-level Young Research Peers and 10 co-opted fellows from the former MEPI-Junior Faculty (MEPI-JF) project. The Young Peers received mentorship from senior researchers from the consortium through mentored research awards and research training, and in turn provided reciprocal peer-to-peer mentorship as well as mentorship to undergraduate students. Results At the end of the first 2 years of the project, all 12 Young Peers were proceeding well with mentored research awards, and some were at more advanced stages. For example, three articles were already published in peer reviewed journals and two other manuscripts were in final stages of preparation. All 12 Young Peers participated in CYRP-wide thematic training workshops on mentoring and secondary data analysis; 11 had undertaken at least three research training short courses in identified areas of need; 9 joined at least one other ongoing research project; 5 made at least one scientific presentation, and 5 participated in at least one submitted grant application. Half of the Young Peers have enrolled in PhD programmes. A collective total of 41 undergraduate students were actively mentored by the Young Peers in research. Conclusion The CYRP has demonstrated to be an effective model for dual vertical and horizontal mentorship in research to young investigators in resource-limited settings. This model is recommended to educators working on developing research competence of early career researchers, particularly in Sub-Saharan Africa.

Organization of the work of the medical laboratory service in accordance with the requirements of the standard GOST ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence»

2020 ◽  
pp. 15-22
Author(s):  
Elena Vitalievna Perminova
Keyword(s):  
Clinical Laboratory ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Iso 15189 ◽  
Laboratory Service ◽  
Medical Laboratories

Clinical laboratory diagnostics is a medical specialty, which is based on in vitro diagnostic studies of biomaterial obtained from an individual. At the present stage, there are three main types of organization of the laboratory research process — a laboratory service as part of a medical and preventive institution, a centralized laboratory where biomaterials are delivered for research from various healthcare institutions, as well as mobile laboratories that allow conducting the research directly at the patient’s bedside. This discipline involves the use of a wide variety of diagnostic research methods and the use of a huge number of specific techniques. Their list should include carrying out hematological, microbiological, virological, immunological, serological, parasitic, and biochemical studies. Also, when organizing laboratory diagnostic activities, a number of other studies (cytological, histological, toxicological, genetic, molecular biological, etc.) are provided. A laboratory report is formulated after obtaining clinical data and comparing them with the obtained test results. The quality of laboratory tests is ensured through the systematic implementation of internal laboratory control, as well as participation in a national program for external quality assessment. The activities of the clinical diagnostic laboratory should be organized in accordance with the requirements of the standard GOST R ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence», which is based on the provisions of two more fundamental standards — ISO 9001 and ISO 17025, and adds a number of special requirements related to medical laboratories.

scholarly journals Laboratory Diagnostics Performance in Uganda: A Survey of Test Availability and Constraints Across 100 Laboratories

2021 ◽  
Author(s):  
Noel Namuhani ◽  
Suzanne N Kiwanuka ◽  
Martha Akulume ◽  
Simeon Kalyesubula ◽  
William Bazeyo ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Disease Diagnosis ◽  
Sub Saharan Africa ◽  
Essential Medicines ◽  
Full Blood Count ◽  
Laboratory Diagnostics ◽  
Cross Sectional ◽  
Laboratory Services ◽  
Control And Prevention ◽  
Sub Saharan

Abstract Background Clinical laboratory services are a critical component of the health system for effective disease diagnosis, treatment, control and prevention. However, many laboratories in Sub Saharan Africa remain dysfunctional. The high costs of tests in the private sector also remain a hindrance to accessing testing services. This study aimed at assessing the functionality of laboratories based on test menus and the associated constraints in Uganda. Methods This cross sectional quantitative study involved an assessment of 100 laboratories randomly selected in 20 districts from four regions of the country. Sixteen percent of the studied laboratories were regional hub laboratories. Laboratory in charges and managers in each of the selected laboratories were interviewed. A checklist for laboratory supplies adapted from the Essential Medicines and Health supplies list for Uganda, (2012) was used to assess availability of testing supplies. Data was analyzed using excel and STATA 14. Results At the point of assessment, generally, all laboratories were able to perform malaria tests and HIV tests. All the hub laboratories conducted malaria tests and TB screening. Less than half had electrolytes tests due to lack of equipment, nonfunctioning equipment and lack of reagents. Full blood count tests were missing in 25% of the hub laboratories mainly due to lack of equipment. The lack of reagents (66.7%) and the lack of equipment (58.3%) caused the majority 10/16 of the hubs to routinely referred specimens for tests that are supposed to be carried out in these laboratories due to lack of reagents (66.7%) and non-functional equipment (58.3%). Although officially recognized as an operational structure, Hub laboratories lacked a list of essential and vital supplies. Conclusions Most laboratories performed well for the common tests. However, many laboratories did not meet testing requirements especially for the advanced tests according to standard testing menus for Uganda due to non-functioning equipment, lack of equipment and reagents. Hubs lack list of essential supplies. Therefore, there is need to provide equipment to laboratories, repair the non-functional ones and develop an essential list of supplies for the hub laboratories.

scholarly journals Rates and predictors of adherence and retention for antiretroviral therapy among HIV-positive adults in Enugu, Nigeria

2019 ◽  
Vol 31 (3) ◽  
pp. 202-211
Author(s):  
Onyinye Hope Chime
Keyword(s):  
Sub Saharan Africa ◽  
People Living With Hiv ◽  
Related Factors ◽  
Art Programs ◽  
Adherence To Medication ◽  
Behavioural Modification ◽  
Resource Limited ◽  
Sub Saharan ◽  
Living With Hiv ◽  
Predictors Of Adherence

BackgroundHIV infection and AIDS are majorpublic health challenges in Nigeria, a country with one of the highest rates of new infection in sub-Saharan Africa and the second largest HIV epidemic in the world.Non-adherence to medication and defaulting from treatment are the two major challenges faced by anti-retroviral therapy (ART) programs in resource-constrained settings. This study was undertaken to determine the rate and predictors of adherence to medication and retention among people living with HIVin Enugu State, Nigeria.MethodsThis was a cross-sectionalretrospective study conducted among adults living with HIV(PLHIV) receiving ARTs in eightcomprehensive health facilities in Enugu, Nigeria. We used self-reported adherence and recorded clinic visits to assess adherence and retention, respectively. Descriptive statistics (frequencies, proportions, mean and standard deviation) and regression analysis were then conducted to identify the association between adherence, retention and demographic and health-related factors. ResultsThe mean age of respondents was 38.5±9.8 years. Predictors of good adherence to medication includedbeing male(adjusted odds ratio [AOR]:2.08; 95% confidence interval [CI]:1.12–3.85), having been on anti-retroviral medications for more than 5 years (AOR:1.92; 95% CI: 1.17–3.16), the non-consumption of alcohol(AOR: 3.67; 95% CI: 2.01–6.70),not usingtraditional medicine (AOR: 2.76; 95% CI:1.33–5.73) and having a baseline CD4count exceeding 500 cells/μl (AOR: 5.67; 95% CI: 1.32–24.32).Adequate retention was predicted by being resident in the urban area (AOR: 1.90; 95% CI: 1.17–3.06). Being away from home (41.8%) and forgetfulness (35.0%) were reported as the major reasons for missing medication.ConclusionThe rates of adherence and retention found in this study were similar to those reported forother resource-limited settings. Health education and behavioural modification interventions should be intensified to reduce the consumption of alcohol and the use of traditional medicine by people living with HIV. Identifying other factors may help to design effective strategies to ensure that people living with HIV adhere to their medications and remain in care.

scholarly journals The Determinants of Large-Scale Land Acquisitions (LSLAs) in Sub-Saharan Africa (SSA): A Case Study

Agriculture ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. 194 ◽  
Author(s):  
Chiara Mazzocchi ◽  
Michele Salvan ◽  
Luigi Orsi ◽  
Guido Sali
Keyword(s):  
Large Scale ◽  
Land Policy ◽  
Sub Saharan Africa ◽  
Land Acquisitions ◽  
Sub Saharan ◽  
Large Scale Land ◽  
Investment Process ◽  
Agricultural Investments ◽  
Formal Recognition

The determinants of large-scale land acquisitions (LSLAs) are, in most cases, outside the traditional sales–buying land market, as they are often rented lands for long periods of time or exploitation licenses. Sub-Saharan Africa is among the most affected regions by this phenomenon for reasons related to its land policy, and includes 37% of the total LSLAs cases. The paper develops an econometric model based on a logarithmic OLS regression to identify the determinants of LSLAs in sub-Saharan Africa. As suggested by the literature, this analysis poses the total agricultural area acquired by country as dependent variable. Results show that investors prefer a country offering a sufficiently free trade economic context with a good level of agricultural productivity, thus allowing an easy investment process. Moreover, a country with a formal recognition of land rights is preferred, to have guarantees on their investment. The availability of water is also one of the main LSLAs drivers, as a natural limit of agricultural investments.

scholarly journals Frequency of Pneumocystis jirovecii in sputum from HIV and TB patients in Namibia

2014 ◽  
Vol 8 (03) ◽  
pp. 349-357 ◽  
Author(s):  
Vincent Nowaseb ◽  
Esegiel Gaeb ◽  
Marcin G Fraczek ◽  
Malcolm D Richardson ◽  
David W Denning
Keyword(s):  
Pneumocystis Pneumonia ◽  
Sub Saharan Africa ◽  
Pneumocystis Jirovecii ◽  
Aids Patients ◽  
Limited Region ◽  
Minimum Frequency ◽  
Resource Limited ◽  
Smear Negative ◽  
Sub Saharan ◽  
Hiv Aids

Introduction: The opportunistic fungus Pneumocystis jirovecii causes Pneumocystis pneumonia (PcP), which is a life-threatening infection in HIV/AIDS patients. The seemingly low prevalence of P. jirovecii pneumonia in sub-Saharan Africa has been a matter of great debate because many HIV/AIDS patients reside in this region. The lack of suitable diagnostic practices in this resource limited-region has been added to the uncertainty of PcP prevalence. Only a few studies have evaluated the utility of easily obtainable samples such as expectorated sputum for diagnosis of PcP. Thus, the aim of the current study was to evaluate the effectiveness of expectorated sputum for the routine diagnosis of PcP in a resource-limited sub-Saharan African setting. Methodology: Randomly collected sputum samples were analysed by microscopy after Grocott’s methenamine silver (GMS) stain staining and by qPCR to determine the minimum frequency of detectable P. jirovecii. Results: A total of 475 samples were analysed. Twenty five (5.3%) samples were positive for P. jirovecii, i.e., 17 (3.6%) using both qPCR and GMS staining and eight (1.7%) using qPCR only. P. jirovecii was present in 8/150 (5.3%) HIV-positive and tuberculosis (TB) smear-negative patients, and in 12/227 (5.3%) TB smear-negative patients with an unknown HIV status. The minimum frequency of PcP was 3.6% in Namibian HIV and TB patients, while the actual frequency is likely to be 5.3%. Conclusion: This study demonstrated that expectorated sputum can be used routinely for the diagnosis of PcP by GMS, although qPCR is more sensitive, and it requires less time and skill.

scholarly journals International Radiotherapy Referrals From Rural Rwanda: Implementation Processes and Early Clinical Outcomes

2018 ◽  
pp. 1-12
Author(s):  
Maud Hanappe ◽  
Lowell T. Nicholson ◽  
Shekinah N.C. Elmore ◽  
Alexandra E. Fehr ◽  
Jean Bosco Bigirimana ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Head And Neck ◽  
Low Income ◽  
Cancer Care ◽  
Sub Saharan Africa ◽  
Resource Limited Settings ◽  
Cancer Centre ◽  
Resource Limited ◽  
Centre Of Excellence ◽  
Sub Saharan

Purpose Low- and middle-income countries disproportionately comprise 65% of cancer deaths. Cancer care delivery in resource-limited settings, especially low-income countries in sub-Saharan Africa, is exceedingly complex, requiring multiple modalities of diagnosis and treatment. Given the vast human, technical, and financial resources required, access to radiotherapy remains limited in sub-Saharan Africa. Through 2017, Rwanda has not had in-country radiotherapy services. The aim of this study was to describe the implementation and early outcomes of the radiotherapy referral program at the Butaro Cancer Centre of Excellence and to identify both successful pathways and barriers to care. Methods Butaro District Hospital is located in a rural area of the Northern Province and is home to the Butaro Cancer Centre of Excellence. We performed a retrospective study from routinely collected data of all patients with a diagnosis of cervical, head and neck, or rectal cancer between July 2012 and June 2015. Results Between 2012 and 2015, 580 patients were identified with these diagnoses and were potential candidates for radiation. Two hundred eight (36%) were referred for radiotherapy treatment in Uganda. Of those referred, 160 (77%) had cervical cancer, 31 (15%) had head and neck cancer, and 17 (8%) had rectal cancer. At the time of data collection, 101 radiotherapy patients (49%) were alive and had completed treatment with no evidence of recurrence, 11 (5%) were alive and continuing treatment, and 12 (6%) were alive and had completed treatment with evidence of recurrence. Conclusion This study demonstrates the feasibility of a rural cancer facility to successfully conduct out-of-country radiotherapy referrals with promising early outcomes. The results of this study also highlight the many challenges and lessons learned in providing comprehensive cancer care in resource-limited settings.

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