Pub Date : 2023-05-31eCollection Date: 2023-01-01DOI: 10.4102/ajlm.v12i1.2119
Jonathan Gwasupika, Victor Daka, Justin Chileshe, Moses Mukosha, Steward Mudenda, Bright Mukanga, Ruth L Mfune, Gershom Chongwe
Background: Coronavirus disease 2019 (COVID-19) is a worldwide public health concern for healthcare workers. About 80% of cases appear to be asymptomatic, and about 3% may experience hospitalisation and later die. Less than 20% of studies have looked at the positivity rate of asymptomatic individuals.
Objective: This study investigated the COVID-19 positivity rates among asymptomatic individuals during the second COVID-19 wave at one of Zambia's largest testing centre.
Methods: This was a retrospective cross-sectional study conducted on routine surveillance and laboratory data at the Tropical Diseases Research Centre COVID-19 laboratory in Ndola, Zambia, from 01 December 2020 to 31 March 2021. The study population was made up of persons that had tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as a requirement for travel. Microsoft Excel was used to come up with an epidemiological curve of daily COVID-19 positive cases; proportions for gender were described using frequencies and percentages.
Results: A total of 11 144 asymptomatic individuals tested for SARS-CoV-2 were sampled for the study and 1781 (16.0%) returned positive results. The median age among those tested was 36 years (interquartile range: 29-46). Testing for COVID-19 peaked in the month of January 2021 (37.4%) and declined in March 2021 (21.0%). The epidemiological curve showed a combination of continuous and propagated point-source transmission.
Conclusion: The positivity rate of 16.0% among asymptomatic individuals was high and could imply continued community transmission, especially during January 2021 and February 2021. We recommend heightened testing for SARS-CoV-2 among asymptomatic individuals.
What this study adds: This study adds critical knowledge to the transmission of COVID-19 among asymptomatic travellers who are usually a key population in driving community infection. This knowledge is critical in instituting evidence-based interventions in the screening and management of travellers, and its control.
{"title":"COVID-19 positive cases among asymptomatic individuals during the second wave in Ndola, Zambia.","authors":"Jonathan Gwasupika, Victor Daka, Justin Chileshe, Moses Mukosha, Steward Mudenda, Bright Mukanga, Ruth L Mfune, Gershom Chongwe","doi":"10.4102/ajlm.v12i1.2119","DOIUrl":"10.4102/ajlm.v12i1.2119","url":null,"abstract":"<p><strong>Background: </strong>Coronavirus disease 2019 (COVID-19) is a worldwide public health concern for healthcare workers. About 80% of cases appear to be asymptomatic, and about 3% may experience hospitalisation and later die. Less than 20% of studies have looked at the positivity rate of asymptomatic individuals.</p><p><strong>Objective: </strong>This study investigated the COVID-19 positivity rates among asymptomatic individuals during the second COVID-19 wave at one of Zambia's largest testing centre.</p><p><strong>Methods: </strong>This was a retrospective cross-sectional study conducted on routine surveillance and laboratory data at the Tropical Diseases Research Centre COVID-19 laboratory in Ndola, Zambia, from 01 December 2020 to 31 March 2021. The study population was made up of persons that had tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as a requirement for travel. Microsoft Excel was used to come up with an epidemiological curve of daily COVID-19 positive cases; proportions for gender were described using frequencies and percentages.</p><p><strong>Results: </strong>A total of 11 144 asymptomatic individuals tested for SARS-CoV-2 were sampled for the study and 1781 (16.0%) returned positive results. The median age among those tested was 36 years (interquartile range: 29-46). Testing for COVID-19 peaked in the month of January 2021 (37.4%) and declined in March 2021 (21.0%). The epidemiological curve showed a combination of continuous and propagated point-source transmission.</p><p><strong>Conclusion: </strong>The positivity rate of 16.0% among asymptomatic individuals was high and could imply continued community transmission, especially during January 2021 and February 2021. We recommend heightened testing for SARS-CoV-2 among asymptomatic individuals.</p><p><strong>What this study adds: </strong>This study adds critical knowledge to the transmission of COVID-19 among asymptomatic travellers who are usually a key population in driving community infection. This knowledge is critical in instituting evidence-based interventions in the screening and management of travellers, and its control.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"2119"},"PeriodicalIF":1.0,"publicationDate":"2023-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10244822/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9601421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-02-07eCollection Date: 2023-01-01DOI: 10.4102/ajlm.v12i1.1956
Denis Omali, Allan Buzibye, Richard Kwizera, Pauline Byakika-Kibwika, Rhoda Namakula, Joshua Matovu, Olive Mbabazi, Emmanuel Mande, Christine Sekaggya-Wiltshire, Damalie Nakanjako, Ursula Gutteck, Keith McAdam, Philippa Easterbrook, Andrew Kambugu, Jan Fehr, Barbara Castelnuovo, Yukari C Manabe, Mohammed Lamorde, Daniel Mueller, Concepta Merry
Background: Research and clinical use of clinical pharmacology laboratories are limited in low- and middle-income countries. We describe our experience in building and sustaining laboratory capacity for clinical pharmacology at the Infectious Diseases Institute, Kampala, Uganda.
Intervention: Existing laboratory infrastructure was repurposed, and new equipment was acquired. Laboratory personnel were hired and trained to optimise, validate, and develop in-house methods for testing antiretroviral, anti-tuberculosis and other drugs, including 10 high-performance liquid chromatography methods and four mass spectrometry methods. We reviewed all research collaborations and projects for which samples were assayed in the laboratory from January 2006 to November 2020. We assessed laboratory staff mentorship from collaborative relationships and the contribution of research projects towards human resource development, assay development, and equipment and maintenance costs. We further assessed the quality of testing and use of the laboratory for research and clinical care.
Lessons learnt: Fourteen years post inception, the clinical pharmacology laboratory had contributed significantly to the overall research output at the institute by supporting 26 pharmacokinetic studies. The laboratory has actively participated in an international external quality assurance programme for the last four years. For clinical care, a therapeutic drug monitoring service is accessible to patients living with HIV at the Adult Infectious Diseases clinic in Kampala, Uganda.
Recommendations: Driven primarily by research projects, clinical pharmacology laboratory capacity was successfully established in Uganda, resulting in sustained research output and clinical support. Strategies implemented in building capacity for this laboratory may guide similar processes in other low- and middle-income countries.
{"title":"Building clinical pharmacology laboratory capacity in low- and middle-income countries: Experience from Uganda.","authors":"Denis Omali, Allan Buzibye, Richard Kwizera, Pauline Byakika-Kibwika, Rhoda Namakula, Joshua Matovu, Olive Mbabazi, Emmanuel Mande, Christine Sekaggya-Wiltshire, Damalie Nakanjako, Ursula Gutteck, Keith McAdam, Philippa Easterbrook, Andrew Kambugu, Jan Fehr, Barbara Castelnuovo, Yukari C Manabe, Mohammed Lamorde, Daniel Mueller, Concepta Merry","doi":"10.4102/ajlm.v12i1.1956","DOIUrl":"10.4102/ajlm.v12i1.1956","url":null,"abstract":"<p><strong>Background: </strong>Research and clinical use of clinical pharmacology laboratories are limited in low- and middle-income countries. We describe our experience in building and sustaining laboratory capacity for clinical pharmacology at the Infectious Diseases Institute, Kampala, Uganda.</p><p><strong>Intervention: </strong>Existing laboratory infrastructure was repurposed, and new equipment was acquired. Laboratory personnel were hired and trained to optimise, validate, and develop in-house methods for testing antiretroviral, anti-tuberculosis and other drugs, including 10 high-performance liquid chromatography methods and four mass spectrometry methods. We reviewed all research collaborations and projects for which samples were assayed in the laboratory from January 2006 to November 2020. We assessed laboratory staff mentorship from collaborative relationships and the contribution of research projects towards human resource development, assay development, and equipment and maintenance costs. We further assessed the quality of testing and use of the laboratory for research and clinical care.</p><p><strong>Lessons learnt: </strong>Fourteen years post inception, the clinical pharmacology laboratory had contributed significantly to the overall research output at the institute by supporting 26 pharmacokinetic studies. The laboratory has actively participated in an international external quality assurance programme for the last four years. For clinical care, a therapeutic drug monitoring service is accessible to patients living with HIV at the Adult Infectious Diseases clinic in Kampala, Uganda.</p><p><strong>Recommendations: </strong>Driven primarily by research projects, clinical pharmacology laboratory capacity was successfully established in Uganda, resulting in sustained research output and clinical support. Strategies implemented in building capacity for this laboratory may guide similar processes in other low- and middle-income countries.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"1956"},"PeriodicalIF":1.2,"publicationDate":"2023-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9982508/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9400527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-30eCollection Date: 2023-01-01DOI: 10.4102/ajlm.v12i1.1964
Abel O Idowu, Yusuf O Omosun, Joseph U Igietseme, Anthony A Azenabor
A novel coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first reported in China in 2019 and later ignited a global pandemic. Contrary to expectations, the effect of the pandemic was not as devastating to Africa and its young population compared to the rest of the world. To provide insight into the possible reasons for the presumed immune sufficiency to coronavirus disease 2019 (COVID-19) in Africa, this review critically examines literature published from 2020 onwards on the dynamics of COVID-19 infection and immunity and how other prevalent infectious diseases in Africa might have influenced the outcome of COVID-19. Studies characterising the immune response in patients with COVID-19 show that the correlates of protection in infected individuals are T-cell responses against the SARS-CoV-2 spike protein and neutralising titres of immunoglobin G and immunoglobin A antibodies. In some other studies, substantial pre-existing T-cell reactivity to SARS-CoV-2 was detected in many people from diverse geographical locations without a history of exposure. Certain studies also suggest that innate immune memory, which offers protection against reinfection with the same or another pathogen, might influence the severity of COVID-19. In addition, an initial analysis of epidemiological data showed that COVID‑19 cases were not severe in some countries that implemented universal Bacillus Calmette-Guerin (BCG) vaccination policies, thus supporting the potential of BCG vaccination to boost innate immunity. The high burden of infectious diseases and the extensive vaccination campaigns previously conducted in Africa could have induced specific and non-specific protective immunity to infectious pathogens in Africans.
一种名为严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)的新型冠状病毒于 2019 年首次在中国报告,随后引发了全球大流行。与预期相反的是,与世界其他地区相比,这次大流行对非洲及其年轻人口的影响并没有那么严重。为了深入了解非洲对冠状病毒病 2019(COVID-19)假定免疫充分的可能原因,本综述对 2020 年以来发表的有关 COVID-19 感染和免疫动态的文献以及非洲其他流行传染病可能如何影响 COVID-19 的结果进行了批判性研究。有关 COVID-19 患者免疫反应特征的研究表明,感染者的保护作用与针对 SARS-CoV-2 尖峰蛋白的 T 细胞反应以及免疫球蛋白 G 和免疫球蛋白 A 抗体的中和滴度有关。在其他一些研究中,来自不同地理位置的许多人在没有接触史的情况下也能检测到对 SARS-CoV-2 的大量预先存在的 T 细胞反应。某些研究还表明,先天性免疫记忆可防止再次感染同一种或另一种病原体,它可能会影响 COVID-19 的严重程度。此外,对流行病学数据的初步分析表明,在一些实施卡介苗(BCG)普遍接种政策的国家,COVID-19 病例并不严重,因此支持卡介苗接种增强先天免疫力的潜力。传染病的高负担和非洲以前开展的广泛疫苗接种运动可能诱发了非洲人对传染病病原体的特异性和非特异性保护性免疫。
{"title":"The COVID-19 pandemic in sub-Saharan Africa: The significance of presumed immune sufficiency.","authors":"Abel O Idowu, Yusuf O Omosun, Joseph U Igietseme, Anthony A Azenabor","doi":"10.4102/ajlm.v12i1.1964","DOIUrl":"10.4102/ajlm.v12i1.1964","url":null,"abstract":"<p><p>A novel coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first reported in China in 2019 and later ignited a global pandemic. Contrary to expectations, the effect of the pandemic was not as devastating to Africa and its young population compared to the rest of the world. To provide insight into the possible reasons for the presumed immune sufficiency to coronavirus disease 2019 (COVID-19) in Africa, this review critically examines literature published from 2020 onwards on the dynamics of COVID-19 infection and immunity and how other prevalent infectious diseases in Africa might have influenced the outcome of COVID-19. Studies characterising the immune response in patients with COVID-19 show that the correlates of protection in infected individuals are T-cell responses against the SARS-CoV-2 spike protein and neutralising titres of immunoglobin G and immunoglobin A antibodies. In some other studies, substantial pre-existing T-cell reactivity to SARS-CoV-2 was detected in many people from diverse geographical locations without a history of exposure. Certain studies also suggest that innate immune memory, which offers protection against reinfection with the same or another pathogen, might influence the severity of COVID-19. In addition, an initial analysis of epidemiological data showed that COVID‑19 cases were not severe in some countries that implemented universal Bacillus Calmette-Guerin (BCG) vaccination policies, thus supporting the potential of BCG vaccination to boost innate immunity. The high burden of infectious diseases and the extensive vaccination campaigns previously conducted in Africa could have induced specific and non-specific protective immunity to infectious pathogens in Africans.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"1964"},"PeriodicalIF":1.1,"publicationDate":"2023-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9900247/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10681655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sanelisiwe T Duze, Teena Thomas, Tshegofatso Pelego, Sabelle Jallow, Olga Perovic, Adriano Duse
This study evaluated the performance of the Xpert Carba-R assay for detecting the five common carbapenemases in carbapenemase-producing organisms in Johannesburg, South Africa between April 2021 and September 2021. The assay demonstrated 98% sensitivity and 97% specificity. It was also able to detect all the carbapenemases in double carbapenemase producers, as well as carbapenemases in non-fermenter organisms. The Xpert Carba-R assay, therefore, allows the rapid (< 1 h) and accurate identification of the common carbapenemases in pure bacterial cultures and rectal swabs. This assay can aid in the timeous institution of appropriate treatment and infection prevention and control measures.
{"title":"Evaluation of Xpert Carba-R for detecting carbapenemase-producing organisms in South Africa.","authors":"Sanelisiwe T Duze, Teena Thomas, Tshegofatso Pelego, Sabelle Jallow, Olga Perovic, Adriano Duse","doi":"10.4102/ajlm.v12i1.1898","DOIUrl":"https://doi.org/10.4102/ajlm.v12i1.1898","url":null,"abstract":"<p><p>This study evaluated the performance of the Xpert Carba-R assay for detecting the five common carbapenemases in carbapenemase-producing organisms in Johannesburg, South Africa between April 2021 and September 2021. The assay demonstrated 98% sensitivity and 97% specificity. It was also able to detect all the carbapenemases in double carbapenemase producers, as well as carbapenemases in non-fermenter organisms. The Xpert Carba-R assay, therefore, allows the rapid (< 1 h) and accurate identification of the common carbapenemases in pure bacterial cultures and rectal swabs. This assay can aid in the timeous institution of appropriate treatment and infection prevention and control measures.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"1898"},"PeriodicalIF":1.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9900380/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10681660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Passoret Vounba, Severin Loul, Ludovic F Tamadea, Joël F D Siawaya
[This corrects the article DOI: 10.4102/ajlm.v11i1.1570.].
[这更正了文章DOI: 10.4102/ ajlc .v11i1.1570.]。
{"title":"Corrigendum: Microbiology laboratories involved in disease and antimicrobial resistance surveillance: Strengths and challenges of the central African states.","authors":"Passoret Vounba, Severin Loul, Ludovic F Tamadea, Joël F D Siawaya","doi":"10.4102/ajlm.v12i1.1913","DOIUrl":"https://doi.org/10.4102/ajlm.v12i1.1913","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.4102/ajlm.v11i1.1570.].</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"1913"},"PeriodicalIF":1.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10244814/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9601427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Immaculate S Dlamini, Verena Gounden, Nareshni Moodley
Background: Inappropriate testing remains a high healthcare cost driver. Tumour marker tests are more expensive than routine chemistry testing. Implementing test demand management systems like electronic gatekeeping (EGK) has reportedly decreased test requests.
Objective: This study aimed to describe the appropriateness of tumour marker tests, carcinoembryonic antigen, alpha foetal protein, prostate-specific antigen, carbohydrate antigen 19-9, cancer antigen 15-3, cancer antigen 125, and human chorionic gonadotropin, and determine the effectiveness of the EGK used in the public health sector in KwaZulu-Natal, South Africa.
Methods: Tumour marker test data for the KwaZulu-Natal province were extracted from the National Health Laboratory Service Central Data Warehouse for 01 January 2017 - 30 June 2017 (pre-EGK) and 01 January 2018 - 30 June 2018 (post-EGK implementation). Questionnaires were sent to the clinicians in the regional hospitals ordering the most tumour marker tests to assess ordering practices. In addition, we assessed monthly rejection reports to determine the effect of the EGK.
Results: The EGK minimally reduced tumour marker requests or associated costs (1.4% average EGK rejection rate). An overall 18% increase in the tumour marker tests occurred in 2018. The data suggest inappropriate tumour marker test utilisation, particularly for screening.
Conclusion: The introduction of EGK as a test demand management had little impact on tumour marker test requests and costs. Continuous education and reiteration of indications for tumour marker test use are required.
What this study adds: This study demonstrates the ineffectiveness of EGK in tumour marker orders, and provides some insight as to why these markers are being ordered, which is important in trying to decrease inappropriate ordering of these tests.
{"title":"Evaluation of tumour marker utilisation and impact of electronic gatekeeping in the province of KwaZulu-Natal, South Africa.","authors":"Immaculate S Dlamini, Verena Gounden, Nareshni Moodley","doi":"10.4102/ajlm.v12i1.2027","DOIUrl":"https://doi.org/10.4102/ajlm.v12i1.2027","url":null,"abstract":"<p><strong>Background: </strong>Inappropriate testing remains a high healthcare cost driver. Tumour marker tests are more expensive than routine chemistry testing. Implementing test demand management systems like electronic gatekeeping (EGK) has reportedly decreased test requests.</p><p><strong>Objective: </strong>This study aimed to describe the appropriateness of tumour marker tests, carcinoembryonic antigen, alpha foetal protein, prostate-specific antigen, carbohydrate antigen 19-9, cancer antigen 15-3, cancer antigen 125, and human chorionic gonadotropin, and determine the effectiveness of the EGK used in the public health sector in KwaZulu-Natal, South Africa.</p><p><strong>Methods: </strong>Tumour marker test data for the KwaZulu-Natal province were extracted from the National Health Laboratory Service Central Data Warehouse for 01 January 2017 - 30 June 2017 (pre-EGK) and 01 January 2018 - 30 June 2018 (post-EGK implementation). Questionnaires were sent to the clinicians in the regional hospitals ordering the most tumour marker tests to assess ordering practices. In addition, we assessed monthly rejection reports to determine the effect of the EGK.</p><p><strong>Results: </strong>The EGK minimally reduced tumour marker requests or associated costs (1.4% average EGK rejection rate). An overall 18% increase in the tumour marker tests occurred in 2018. The data suggest inappropriate tumour marker test utilisation, particularly for screening.</p><p><strong>Conclusion: </strong>The introduction of EGK as a test demand management had little impact on tumour marker test requests and costs. Continuous education and reiteration of indications for tumour marker test use are required.</p><p><strong>What this study adds: </strong>This study demonstrates the ineffectiveness of EGK in tumour marker orders, and provides some insight as to why these markers are being ordered, which is important in trying to decrease inappropriate ordering of these tests.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"2027"},"PeriodicalIF":1.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10331048/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10191220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Despite the tremendous progress made in advancing laboratory medicine in low- and middle-income countries (LMICs), inadequate quality management systems (QMSs) remain a problem and barrier to provision of reliable laboratory services in resource-limited settings. Therefore, it is useful to study the experience of medical laboratories in LMICs that have successfully implemented QMS.
Aim: This review identified key success factors (KSFs) for medical laboratories in LMICs implementing QMS in accordance with the International Organization for Standardization standard 15189 as a pathway to improving laboratory quality.
Methods: Applying Preferred Reporting Items for Systematic Reviews procedures, we conducted a targeted search of studies from LMICs published between 2012 and 2022 to identify KSFs. Thirty-two out of 952 references retrieved were considered relevant and included in this review. Grounded theory was used to extract key features of the included studies to derive KSFs.
Results: Ten KSFs for medical laboratories striving to implement QMS were identified and described. These KSFs were integrated to create a model of success for laboratory QMS implementation. The model consists of three underlying factors, namely preparing for change, resource availability, and effective project management, each comprising three separate KSFs. Institutional commitment was identified as the core of the model and is integral to ensuring the quality of laboratory services.
Conclusion: Laboratories planning to implement a QMS can benefit from understanding the KSFs demonstrated in this study as this would help them to identify the necessary changes to implement and set realistic expectations about the outcomes of QMS implementation.
{"title":"Key success factors for the implementation of quality management systems in developing countries.","authors":"Iryna Tanasiichuk, Olha Karaman, Larysa Natrus","doi":"10.4102/ajlm.v12i1.2058","DOIUrl":"https://doi.org/10.4102/ajlm.v12i1.2058","url":null,"abstract":"<p><strong>Background: </strong>Despite the tremendous progress made in advancing laboratory medicine in low- and middle-income countries (LMICs), inadequate quality management systems (QMSs) remain a problem and barrier to provision of reliable laboratory services in resource-limited settings. Therefore, it is useful to study the experience of medical laboratories in LMICs that have successfully implemented QMS.</p><p><strong>Aim: </strong>This review identified key success factors (KSFs) for medical laboratories in LMICs implementing QMS in accordance with the International Organization for Standardization standard 15189 as a pathway to improving laboratory quality.</p><p><strong>Methods: </strong>Applying Preferred Reporting Items for Systematic Reviews procedures, we conducted a targeted search of studies from LMICs published between 2012 and 2022 to identify KSFs. Thirty-two out of 952 references retrieved were considered relevant and included in this review. Grounded theory was used to extract key features of the included studies to derive KSFs.</p><p><strong>Results: </strong>Ten KSFs for medical laboratories striving to implement QMS were identified and described. These KSFs were integrated to create a model of success for laboratory QMS implementation. The model consists of three underlying factors, namely preparing for change, resource availability, and effective project management, each comprising three separate KSFs. Institutional commitment was identified as the core of the model and is integral to ensuring the quality of laboratory services.</p><p><strong>Conclusion: </strong>Laboratories planning to implement a QMS can benefit from understanding the KSFs demonstrated in this study as this would help them to identify the necessary changes to implement and set realistic expectations about the outcomes of QMS implementation.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"2058"},"PeriodicalIF":1.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9900284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10674754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: The Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) helps prepare laboratories in low- and middle-income countries to achieve international accreditation aligned with the ISO 15189:2012 standards. Accreditation by the Joint Commission International (JCI) is among the highest sought by hospitals worldwide. While the readiness of laboratories with a five-star SLIPTA score to undergo ISO 15189:2012 accreditation was recently assessed, the compliance of the SLIPTA checklist with JCI is still unknown.
Objective: The study evaluated the SLIPTA checklist's utility in assessing laboratories to meet the JCI standards.
Methods: We conducted a detailed gap analysis between SLIPTA and JCI laboratory standards from January 2021 to January 2022. We cross-matched the JCI standard requirements to SLIPTA clauses and categorised each standard into 'met', 'partially met', and 'not met'. We highlighted similarities, discrepancies, and improvement areas.
Results: A total of 109 JCI standards were included. The SLIPTA checklist completely met 61 standards, partially met four, but did not meet 44. The unmet JCI standards focused on the quality planning, control, and improvement sections. Healthcare organisation management and quality control processes, including selecting an accredited reference laboratory, collecting quality management data, creating of post-analytical policies and procedures, and validating monitoring systems, constitute the basis of this preparation.
Conclusion: The SLIPTA checklist covers major quality management system elements of the JCI standards for laboratories. However, some components should be addressed to assure readiness for JCI accreditation.
What this study adds: This study identified additional areas not covered by the SLIPTA checklist that are required for JCI accreditation.
{"title":"Using the SLIPTA checklist to assess laboratory readiness for Joint Commission International accreditation.","authors":"Abdul K El Karaaoui, Nada Assaf","doi":"10.4102/ajlm.v12i1.2044","DOIUrl":"https://doi.org/10.4102/ajlm.v12i1.2044","url":null,"abstract":"<p><strong>Background: </strong>The Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) helps prepare laboratories in low- and middle-income countries to achieve international accreditation aligned with the ISO 15189:2012 standards. Accreditation by the Joint Commission International (JCI) is among the highest sought by hospitals worldwide. While the readiness of laboratories with a five-star SLIPTA score to undergo ISO 15189:2012 accreditation was recently assessed, the compliance of the SLIPTA checklist with JCI is still unknown.</p><p><strong>Objective: </strong>The study evaluated the SLIPTA checklist's utility in assessing laboratories to meet the JCI standards.</p><p><strong>Methods: </strong>We conducted a detailed gap analysis between SLIPTA and JCI laboratory standards from January 2021 to January 2022. We cross-matched the JCI standard requirements to SLIPTA clauses and categorised each standard into 'met', 'partially met', and 'not met'. We highlighted similarities, discrepancies, and improvement areas.</p><p><strong>Results: </strong>A total of 109 JCI standards were included. The SLIPTA checklist completely met 61 standards, partially met four, but did not meet 44. The unmet JCI standards focused on the quality planning, control, and improvement sections. Healthcare organisation management and quality control processes, including selecting an accredited reference laboratory, collecting quality management data, creating of post-analytical policies and procedures, and validating monitoring systems, constitute the basis of this preparation.</p><p><strong>Conclusion: </strong>The SLIPTA checklist covers major quality management system elements of the JCI standards for laboratories. However, some components should be addressed to assure readiness for JCI accreditation.</p><p><strong>What this study adds: </strong>This study identified additional areas not covered by the SLIPTA checklist that are required for JCI accreditation.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"2044"},"PeriodicalIF":1.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10091060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9371287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jenipher G Mwakyabala, Conjester I Mtemisika, Stacy Mshana, Adam A Mwakyoma, Vitus Silago
Healthcare-associated infections (HCAIs) caused by extended spectrum β-lactamase-producing Gram-negative bacteria (ESBL-GNB) increase morbidity and mortality. This cross-sectional study characterised ESBL genes (blaCTX-M, blaTEM and blaSHV) among 30 ceftriaxone-resistant GNB causing HCAIs between January 2022 and July 2022 by multiplex polymerase chain reaction assay at the zonal referral hospital in Mwanza, Tanzania. Twenty-five (83.3%) had at least one ESBL gene, of which 23/25 (92.0%) carried the blaCTX-M gene. Seventy-two percent (18/25) of the GNB-ESBL isolates carried more than one ESBL gene, of which the majority (88.8%; n = 16/25) carried the blaCTX-M and blaTEM genes. Extended spectrum β-lactamase genes, particularly blaCTX-M, are common among ceftriaxone-resistant GNB causing HCAIs.
What this study adds: This study revealed the distribution of genes (blaCTX-M, blaTEM and blaSHV) coding for ESBL production among ceftriaxone resistant GNB causing HCAIs However, all ESBL producing GNB were susceptible towards ceftriaxone-sulbactam indicating that ceftriaxone-sulbactam may be empirically prescribed for treating patients with HCAIs.
{"title":"Characterisation of genes encoding for extended spectrum β-lactamase in Gram-negative bacteria causing healthcare-associated infections in Mwanza, Tanzania.","authors":"Jenipher G Mwakyabala, Conjester I Mtemisika, Stacy Mshana, Adam A Mwakyoma, Vitus Silago","doi":"10.4102/ajlm.v12i1.2107","DOIUrl":"https://doi.org/10.4102/ajlm.v12i1.2107","url":null,"abstract":"<p><p>Healthcare-associated infections (HCAIs) caused by extended spectrum β-lactamase-producing Gram-negative bacteria (ESBL-GNB) increase morbidity and mortality. This cross-sectional study characterised ESBL genes (<i>bla</i> <sub>CTX-M</sub>, <i>bla</i> <sub>TEM</sub> and <i>bla</i> <sub>SHV</sub>) among 30 ceftriaxone-resistant GNB causing HCAIs between January 2022 and July 2022 by multiplex polymerase chain reaction assay at the zonal referral hospital in Mwanza, Tanzania. Twenty-five (83.3%) had at least one ESBL gene, of which 23/25 (92.0%) carried the <i>bla</i> <sub>CTX-M</sub> gene. Seventy-two percent (18/25) of the GNB-ESBL isolates carried more than one ESBL gene, of which the majority (88.8%; <i>n</i> = 16/25) carried the <i>bla</i> <sub>CTX-M</sub> and <i>bla</i> <sub>TEM</sub> genes. Extended spectrum β-lactamase genes, particularly <i>bla</i> <sub>CTX-M</sub>, are common among ceftriaxone-resistant GNB causing HCAIs.</p><p><strong>What this study adds: </strong>This study revealed the distribution of genes (<i>bla</i> <sub>CTX-M</sub>, <i>bla</i> <sub>TEM</sub> and <i>bla</i> <sub>SHV</sub>) coding for ESBL production among ceftriaxone resistant GNB causing HCAIs However, all ESBL producing GNB were susceptible towards ceftriaxone-sulbactam indicating that ceftriaxone-sulbactam may be empirically prescribed for treating patients with HCAIs.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"2107"},"PeriodicalIF":1.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10157427/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9485164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Symon F Nayupe, Patrick Mbulaje, Steven Munharo, Parth Patel, Don E Lucero-Prisno
Medical practice has evolved over the past years from symptom-based clinical diagnoses to evidence-based diagnoses demanding clinical laboratory investigations. Clinical experts at the Mayo Clinic in the United States estimated that almost 70% of patient management decisions rely on laboratory diagnostic information.1,2 In sub-Saharan Africa, the need for quality diagnostic services is apparent; nevertheless, access to quality and reliable laboratory services in the region has been a big challenge.3
{"title":"Medical laboratory practice in Malawi - Current status.","authors":"Symon F Nayupe, Patrick Mbulaje, Steven Munharo, Parth Patel, Don E Lucero-Prisno","doi":"10.4102/ajlm.v12i1.1921","DOIUrl":"https://doi.org/10.4102/ajlm.v12i1.1921","url":null,"abstract":"Medical practice has evolved over the past years from symptom-based clinical diagnoses to evidence-based diagnoses demanding clinical laboratory investigations. Clinical experts at the Mayo Clinic in the United States estimated that almost 70% of patient management decisions rely on laboratory diagnostic information.1,2 In sub-Saharan Africa, the need for quality diagnostic services is apparent; nevertheless, access to quality and reliable laboratory services in the region has been a big challenge.3","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"12 1","pages":"1921"},"PeriodicalIF":1.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9900340/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10681657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}