Implementation of the COVID-19 laboratory testing certification program (CoLTeP), Zimbabwe, 2021.

The Africa Union (AU) Trusted Travel Initiative was introduced in 2021 to support Africa Union member states enhance their current health screening systems. Trusted Travel offers an online digital platform for the verification and authentication of COVID-19 results based on a collaborative effort across a network of participating COVID-19 testing laboratories. In this paper, we describe the certification process of laboratories to qualify for listing on the AU Trusted Travel platform as approved and recognized COVID-19 testing facilities. A checklist prepared from the ISO15189: 2012, ISO15190: 2020 and World Health Organization Laboratory Safety Manual, 4th edition was used to audit laboratories. Approved auditors completed the audit checklist through reviewing laboratory documents and records, observing laboratory operations whilst asking open-ended questions to clarify documentation seen and observations made. A laboratory was recommended for certification after scoring at least 90%. Between May and September 2021, a total of 26 (19%) of the 134 medical laboratories authorized for SARS-CoV-2 testing had been audited for CoLTeP certification in Zimbabwe. The majority 16 (62%) attained 5 stars rating with 10 (38%) attaining 0-4 stars. Performance was highest in the area of test result and data management (mean score 93%, SD 9.1). The least performance of the laboratories was on the laboratory biosafety and biosecurity (mean score 73%, SD 17.0) and Quality Control and Assurance (mean score 71%, SD 15.0). There is need for laboratories to commit their resources to quality assurance programs and training of laboratory personnel in biosafety and biosecurity as part of continuous quality improvement.

Implementation of COVID-19 Laboratory Testing Certification Program (CoLTeP) in African Region.

Objectives: Coronavirus disease 2019 was declared a global pandemic in March 2020 with correct and early detection of cases using laboratory testing central to the response. Hence, the establishment of quality management systems and monitoring their implementation are critical. This study describes the experience of implementing the COVID-19 Laboratory Testing and Certification Program (CoLTeP) in Africa. Methods: Private and public laboratories conducting SARS-CoV-2 testing using polymerase chain reaction were enrolled and assessed for quality and safety using the CoLTeP checklists. Results: A total of 84 laboratories from 7 countries were assessed between April 2021 to December 2021 with 52% of these from the private sector. Among them, 64% attained 5 stars and were certified. Section 4 had the highest average score of 92% and the lowest of 78% in Section 3. Also, 82% of non-conformities (NCs) were related to sample collection, transportation, and risk assessments. Non-availability, inconsistency in performing, recording, instituting corrective actions for failed internal and external quality controls were among major NCs reported. Conclusions: Laboratories identified for SARS-CoV-2 testing by public and private institutions mostly met the requirements for quality and safe testing as measured by the CoLTeP checklist.

Impact of pre-COVID-19 epidemic preparedness on the trajectory of the pandemic in African countries.

Background: The novel coronavirus disease 2019 (COVID-19), declared a pandemic by the World Health Organization (WHO) in March 2020, has taught us about the importance of epidemic preparedness. Objective: We analysed the pre-COVID-19 preparedness of sub-Saharan African countries and how this may have influenced the trajectory of COVID-19 cases. Methods: The WHO Joint External Evaluation (JEE) tool and the Global Health Security (GHS) Index were used to determine the epidemic preparedness of countries in the WHO African Region. The relationship between pre-COVID-19 preparedness and the reported number of cases per million people was evaluated over the first 120 days of the first reported case in each country, between February 2020 and September 2020. Results: The overall performance of the 42 countries was 40% in the 19 JEE core capacities and 32% in the six GHS Index indicators. At Day 1, the mean number of cases per million population was significantly higher among countries rated as 'prepared' in the JEE legislation, policy and finance (p = 0.03), ports of entry (p = 0.001), and international health regulation coordination, communication and advocacy (p = 0.03) categories. At Day 90, countries rated as 'prepared' in the national laboratory systems (p = 0.05) and real-time surveillance (p = 0.04) JEE categories had statistically significantly fewer cases per million population. Conclusion: This analysis highlights the importance of building capacity for pandemic preparedness in Africa. The WHO African Region was not adequately prepared for the COVID-19 pandemic as measured by the WHO JEE tool and the GHS Index.

Impact of pre-COVID-19 epidemic preparedness on the trajectory of the pandemic in African countries

Background: The novel coronavirus disease 2019 (COVID-19), declared a pandemic by the World Health Organization (WHO) in March 2020, has taught us about the importance of epidemic preparedness. Objective: We analysed the pre-COVID-19 preparedness of sub-Saharan African countries and how this may have influenced the trajectory of COVID-19 cases. Methods: The WHO Joint External Evaluation (JEE) tool and the Global Health Security (GHS) Index were used to determine the epidemic preparedness of countries in the WHO African Region. The relationship between pre-COVID-19 preparedness and the reported number of cases per million people was evaluated over the first 120 days of the first reported case in each country, between February 2020 and September 2020. Results: The overall performance of the 42 countries was 40% in the 19 JEE core capacities and 32% in the six GHS Index indicators. At Day 1, the mean number of cases per million population was significantly higher among countries rated as 'prepared' in the JEE legislation, policy and finance (p = 0.03), ports of entry (p = 0.001), and international health regulation coordination, communication and advocacy (p = 0.03) categories. At Day 90, countries rated as 'prepared' in the national laboratory systems (p = 0.05) and real-time surveillance (p = 0.04) JEE categories had statistically significantly fewer cases per million population. Conclusion: This analysis highlights the importance of building capacity for pandemic preparedness in Africa. The WHO African Region was not adequately prepared for the COVID-19 pandemic as measured by the WHO JEE tool and the GHS Index.

Haematological reference intervals for healthy adults in Bamenda, Cameroon.

BACKGROUND: In the era of evidence-based medicine, haematological reference intervals are essential for the interpretation of data for clinical decision-making, monitoring of treatment and research. It is not uncommon that reference intervals used in most African countries have been obtained from published scientific literature, textbooks, reagent/instrument manuals. OBJECTIVE: The aim of this study was to determine haematological reference intervals of healthy adults in Bamenda, Cameroon. METHODS: This was a cross-sectional study conducted between June and November 2015. Participants were voluntary blood donors at the Blood Bank Service of the Regional Hospital Bamenda aged between 18 and 65 years. The mean, median and standard deviation of the mean were calculated for each haematological parameter. The 95th percentile reference intervals were determined using the 2.5th and 97.5th percentile. The differences between gender for all the parameters were evaluated using the Kruskal-Wallis test. Significance was determined at the 95% confidence level. RESULTS: Out of a total of 340 participants, 202 (59.4%) were men and 138 (40.6%) were women. The median red blood cell, haemoglobin, haematocrit and mean cell haemoglobin concentration were significantly higher in men than women (p < 0.001). The median white blood cell, absolute lymphocytes count, absolute granulocytes and platelet counts for men were significantly lower than those for women (p < 0.011). CONCLUSION: We propose that the present established haematological reference intervals in this study should be used for clinical management of patients and interpretation of laboratory data for research in Bamenda.

Implementation of the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation.

BACKGROUND: The increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis, management and treatment of diseases. In response, the World Health Organization Regional Office for Africa (WHO AFRO) and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program. SLIPTA IMPLEMENTATION PROCESS: WHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1-5 stars were issued. PRELIMINARY RESULTS: By March 2015, 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries, competent in the Portuguese (3), French (12) and English (83) languages, were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62-77). Of these audited laboratories, 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action), which both had mean scores below 50%. CONCLUSION: The WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment, ownership and investment in continuous quality improvement are integral components of the process.

Implementation of the world health organization regional office for africa stepwise laboratory quality improvement process towards accreditation

Background: The increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis; management and treatment of diseases. In response; the World Health Organization Regional Office for Africa (WHO AFRO) and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program.SLIPTA implementation process: WHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1-5 stars were issued. Preliminary results: By March 2015; 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries; competent in the Portuguese (3); French (12) and eng (83) languages; were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62-77). Of these audited laboratories; 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action); which both had mean scores below 50%.Conclusion: The WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment; ownership and investment in continuous quality improvement are integral components of the process

From grass to grace: how SLMTA revolutionised the Bamenda Regional Hospital Laboratory in Cameroon

Background: Public health laboratories form the foundation on which today's clinical laboratory practice in Cameroon is built. The advent of the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme in 2009 empowered the Bamenda Regional Hospital Laboratory (BRHL) to improve its working culture; practices and management. Objectives: To evaluate the results of SLMTA implementation at BRHL and discuss lessons learned.Method: In 2010; the SLMTA programme was rolled out in Cameroon to improve laboratory quality management systems in five laboratories; including BRHL. Three workshops were conducted (the first centralised; the remaining two on-site at each laboratory) and improvement projects were implemented after each workshop with the assistance of mentors. Audits were used in order to evaluate performance and to identify areas for further improvement.Results: BRHL had the lowest score (18%) amongst the cohort at the baseline audit and the highest (81%) at the official Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) audit conducted in August 2013 by the African Society for Laboratory Medicine. Improvements were observed in each of the 12 Quality System Essentials; improvement was especially noteworthy in the areas of facilities and safety; and purchasing and inventory. Staff investment and pride in the quality of laboratory servicesincreased. Conclusion: BRHL's remarkable improvement was achieved with a combination of SLMTA training activities; intensive on-site mentorship and the collective focus of all laboratory staff. The experience at Bamenda Hospital illustrates what can be achieved when a laboratory successfully harnesses the energy of its staff and implements changes to improve the quality of services in a transformation taking them from grass to grace

The impact of SLMTA in improving laboratory quality systems in the Caribbean Region.

BACKGROUND: Past efforts to improve laboratory quality systems and to achieve accreditation for better patient care in the Caribbean Region have been slow. OBJECTIVE: To describe the impact of the Strengthening of Laboratory Management Toward Accreditation (SLMTA) training programme and mentorship amongst five clinical laboratories in the Caribbean after 18 months. METHOD: Five national reference laboratories from four countries participated in the SLMTA programme that incorporated classroom teaching and implementation of improvement projects. Mentors were assigned to the laboratories to guide trainees on their improvement projects and to assist in the development of Quality Management Systems (QMS). Audits were conducted at baseline, six months, exit (at 12 months) and post-SLMTA (at 18 months) using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist to measure changes in implementation of the QMS during the period. At the end of each audit, a comprehensive implementation plan was developed in order to address gaps. RESULTS: Baseline audit scores ranged from 19% to 52%, corresponding to 0 stars on the SLIPTA five-star scale. After 18 months, one laboratory reached four stars, two reached three stars and two reached two stars. There was a corresponding decrease in nonconformities and development of over 100 management and technical standard operating procedures in each of the five laboratories. CONCLUSION: The tremendous improvement in these five Caribbean laboratories shows that SLMTA coupled with mentorship is an effective, user-friendly, flexible and customisable approach to the implementation of laboratory QMS. It is recommended that other laboratories in the region consider using the SLMTA training programme as they engage in quality systems improvement and preparation for accreditation.

The SLMTA programme: Transforming the laboratory landscape in developing countries.

BACKGROUND: Efficient and reliable laboratory services are essential to effective and well-functioning health systems. Laboratory managers play a critical role in ensuring the quality and timeliness of these services. However, few laboratory management programmes focus on the competencies required for the daily operations of a laboratory in resource-limited settings. This report provides a detailed description of an innovative laboratory management training tool called Strengthening Laboratory Management Toward Accreditation (SLMTA) and highlights some challenges, achievements and lessons learned during the first five years of implementation (2009-2013) in developing countries. PROGRAMME: SLMTA is a competency-based programme that uses a series of short courses and work-based learning projects to effect immediate and measurable laboratory improvement, while empowering laboratory managers to implement practical quality management systems to ensure better patient care. A SLMTA training programme spans from 12 to 18 months; after each workshop, participants implement improvement projects supported by regular supervisory visits or on-site mentoring. In order to assess strengths, weaknesses and progress made by the laboratory, audits are conducted using the World Health Organization's Regional Office for Africa (WHO AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist, which is based on International Organization for Standardization (ISO) 15189 requirements. These internal audits are conducted at the beginning and end of the SLMTA training programme. CONCLUSION: Within five years, SLMTA had been implemented in 617 laboratories in 47 countries, transforming the laboratory landscape in developing countries. To our knowledge, SLMTA is the first programme that makes an explicit connection between the performance of specific management behaviours and routines and ISO 15189 requirements. Because of this close relationship, SLMTA is uniquely positioned to help laboratories seek accreditation to ISO 15189.

Training-of-trainers: A strategy to build country capacity for SLMTA expansion and sustainability.

BACKGROUND: The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme uses a training-of-trainers (TOT) model to build capacity for programme scale-up. The TOT strategy is designed to maximise utilisation of its graduates whilst minimising inconsistencies and ensuring high programme quality during global expansion. OBJECTIVES: To describe the SLMTA TOT programme approach. METHODS: The two-week training, led by carefully selected and trained master trainers, enables effective and authentic implementation of the curriculum by its graduates. The teachback methodology used allows participants to practise teaching the curriculum whilst learning its content. A trainer's toolkit provides all the materials necessary for teaching and must be followed faithfully during training. Two surveys were conducted to assess the effectiveness of the TOT strategy: one sent to 316 TOT graduates in 25 countries and the other sent to the programme leaders in 10 countries. RESULTS: By the end of 2013, 433 SLMTA trainers had been trained who, in turn, taught more than 1900 people to implement SLMTA in 617 laboratories in 47 countries. Ninety-seven percent of the 433 TOT graduates and 87% of the 38 master trainers are based in developing countries. Ninety-two per cent of the graduates have been utilised at least once in programme implementation and, as of August 2013, 87% of them were still actively involved in programme activities. Ninety-seven per cent of the graduates stated that the TOT workshop prepared them well for training or other programme tasks. CONCLUSION: The SLMTA TOT strategy is effective in building local capacity for global programme expansion whilst maintaining programme quality.

From grass to grace: How SLMTA revolutionised the Bamenda Regional Hospital Laboratory in Cameroon.

BACKGROUND: Public health laboratories form the foundation on which today's clinical laboratory practice in Cameroon is built. The advent of the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme in 2009 empowered the Bamenda Regional Hospital Laboratory (BRHL) to improve its working culture, practices and management. OBJECTIVES: To evaluate the results of SLMTA implementation at BRHL and discuss lessons learned. METHOD: In 2010, the SLMTA programme was rolled out in Cameroon to improve laboratory quality management systems in five laboratories, including BRHL. Three workshops were conducted (the first centralised, the remaining two on-site at each laboratory) and improvement projects were implemented after each workshop with the assistance of mentors. Audits were used in order to evaluate performance and to identify areas for further improvement. RESULTS: BRHL had the lowest score (18%) amongst the cohort at the baseline audit and the highest (81%) at the official Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) audit conducted in August 2013 by the African Society for Laboratory Medicine. Improvements were observed in each of the 12 Quality System Essentials; improvement was especially noteworthy in the areas of facilities and safety, and purchasing and inventory. Staff investment and pride in the quality of laboratory services increased. CONCLUSION: BRHL's remarkable improvement was achieved with a combination of SLMTA training activities, intensive on-site mentorship and the collective focus of all laboratory staff. The experience at Bamenda Hospital illustrates what can be achieved when a laboratory successfully harnesses the energy of its staff and implements changes to improve the quality of services in a transformation taking them from grass to grace.

Setting up a structured laboratory mentoring programme.

INTRODUCTION: Laboratory mentoring programmes can be an important vehicle to establish and solidify quality management systems and help laboratories achieve accreditation goals. Different mentoring approaches have been used with varying levels of success. The authors provide a guide to implementing a structured laboratory mentorship programme based on their practical field experience. METHOD: The study is based on experience in Lesotho as well as subsequent roll out of a similar approach in the other African countries of Zimbabwe, Mozambique, Swaziland and Cameroon between 2009 and 2011. SUMMARY: We highlight critical elements to consider when setting up a long-term, sustainable and well-structured mentorship programme. These elements include: well-defined goals; sufficient length of mentor engagement on site; standardised approach across laboratories; measurement of progress using standardised tools; well-structured reporting mechanisms; alignment of the programme with overall Ministry of Health plans; and selection and training of the mentors. These elements will differ in application, depending on countries' needs and available resources. A structured approach allows for scalability, comparison across laboratories and countries and an easier approach to budgeting and planning for countries intending to set up similar programmes.

Immunohaematological reference values for HIV-negative healthy adults in Botswana.

BACKGROUND: Clinical laboratories in Botswana have relied entirely on the reference intervals for normal immunohaematological values provided by manufacturers' kits and textbooks. OBJECTIVES: The aim of this study was to determine the means, medians, 2.5th and 97.5th percentile reference intervals, for normal immunohaematological values in healthy adults in Botswana. METHOD: A total of 261 healthy participants comprising 126 men (48%) and 135 (52%) women were enrolled in the southern part of Botswana, and immunological and haematological laboratory parameters were measured. RESULTS: The mean age was 28.8 (95% Confidence Interval [CI] 27.7-29.8) years, with a median of 27 years and a range 18-66 years. The mean haemoglobin level was significantly lower for women (12.4 g/dL; 95% CI 12.1% - 12.7%) than men (15.1 g/dL; 95% CI 14.9% - 15.3%). The women's haemoglobin reference values (9.0 g/dL - 15.0 g/dL) levels were lower than observed in predominantly White populations (12.0 g/dL - 16.0 g/dL), but comparable with regional consensus reference intervals (9.5 g/dL - 15.8 g/dL) recently defined for East and Southern Africa. CONCLUSION: The established values provide an important tool for patient management and could influence decisions on inclusion of participants and adverse events in clinical trials conducted locally.

Impact of mentorship on WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA).

BACKGROUND: The improvment of the quality of testing services in public laboratories is a high priority in many countries. Consequently, initiatives to train laboratory staff on quality management are being implemented, for example, the World Health Organization Regional Headquarters for Africa (WHO-AFRO) Strengthening Laboratory Management Towards Accreditation (SLMTA). Mentorship may be an effective way to augment these efforts. METHODS: Mentorship was implemented at four hospital laboratories in Lesotho, three districts and one central laboratory, between June 2009 and December 2010. The mentorship model that was implemented had the mentor fully embedded within the operations of each of the laboratories. It was delivered in a series of two mentoring engagements of six and four week initial and follow-up visits respectively. In total, each laboratory received 10 weeks mentorship that was separated by 6-8 weeks. Quality improvements were measured at baseline and at intervals during the mentorship using the WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist and scoring system. RESULTS: At the beginning of the mentorship, all laboratories were at the SLIPTA zero star rating. After the initial six weeks of mentorship, two of the three district laboratories had improved from zero to one (out of five) star although the difference between their baseline (107.7) and the end of the six weeks (136.3) average scores was not statistically significant (p = 0.25). After 10 weeks of mentorship there was a significant improvement in average scores (182.3; p = 0.034) with one laboratory achieving WHO-AFRO three out of a possible five star status and the two remaining laboratories achieving a two star status. At Queen Elizabeth II (QE II) Central Laboratory, the average baseline score was 44%, measured using a section-specific checklist. There was a significant improvement by five weeks (57.2%; p = 0.021). CONCLUSION: The mentorship programme in this study resulted in significant measurable improvements towards preparation for the WHO-AFRO SLIPTA process in less than six months. We recommend that mentorship be incorporated into laboratory quality improvement and management training programmes such as SLMTA, in order to accelerate the progress of laboratories towards achieving accreditation.

Strengthening Laboratory Management Towards Accreditation: The Lesotho experience.

INTRODUCTION: The Lesotho Ministry of Health and Social Welfare's (MOHSW) 5-year strategic plan, as well as their national laboratory policy and yearly operational plans, directly addresses issues of accreditation, indicating their commitment to fulfilling their mandate. As such, the MOHSW adopted the World Health Organization Regional Headquarters for Africa's Stepwise Laboratory Quality Improvement Toward Accreditation (WHO-AFRO-SLIPTA) process and subsequently rolled out the Strengthening Laboratory Management Towards Accreditation (SLMTA) programme across the whole country, becoming the first African country to do so. METHODS: SLMTA in Lesotho was implemented in two cohorts. Twelve and nineteen laboratory supervisors and quality officers were enrolled in Cohort 1 and Cohort 2, respectively. These 31 participants represented 18 of the 19 laboratories nationwide. For the purposes of this programme, the Queen Elizabeth II (QE II) Central Laboratory had its seven sections of haematology, blood bank, cytology, blood transfusion, microbiology, tuberculosis laboratory and chemistry assessed as separate sections. Performance was tracked using the WHO-AFRO-SLIPTA checklist, with assessments carried out at baseline and at the end of SLMTA. Two methods were used to implement SLMTA: the traditional 'three workshops' approach and twinning SLMTA with mentorship. The latter, with intensive follow-up visits, was concluded in 9 months and the former in 11 months. A standard data collection tool was used for site visits. RESULTS: Of the 31 participants across both cohorts, 25 (81%) graduated (9 from Cohort 1 and 16 from Cohort 2). At baseline, all but one laboratory attained a rating of zero stars, with the exception attaining one star. At the final assessment, 7 of the 25 laboratories examined at baseline were still at a rating of zero stars, whilst 8 attained one star, 5 attained two stars and 4 attained three stars. None scored above three stars. The highest percentage improvement for any laboratory was 51%, whereas the least improved dropped by 6% when compared to its baseline assessment. The most improved areas were corrective actions (34%) and documents and records (32%). Process improvement demonstrated the least improvement (10%). CONCLUSION: The SLMTA programme had an immediate, measurable and positive impact on laboratories in Lesotho. This success was possible because of the leadership and ownership of the programme by the MOHSW, as well as the coordination of partner support.

Immunohaematological reference values for HIV-negative healthy adults in Botswana.

BACKGROUND: Clinical laboratories in Botswana have relied entirely on the reference intervals for normal immunohaematological values provided by manufacturers' kits and textbooks. OBJECTIVES: The aim of this study was to determine the means, medians, 2.5th and 97.5th percentile reference intervals, for normal immunohaematological values in healthy adults in Botswana. METHOD: A total of 261 healthy participants comprising 126 men (48%) and 135 (52%) women were enrolled in the southern part of Botswana, and immunological and haematological laboratory parameters were measured. RESULTS: The mean age was 28.8 (95% Confidence Interval [CI] 27.7-29.8) years, with a median of 27 years and a range 18-66 years. The mean haemoglobin level was significantly lower for women (12.4 g/dL; 95% CI 12.1% - 12.7%) than men (15.1 g/dL; 95% CI 14.9% - 15.3%). The women's haemoglobin reference values (9.0 g/dL - 15.0 g/dL) levels were lower than observed in predominantly White populations (12.0 g/dL - 16.0 g/dL), but comparable with regional consensus reference intervals (9.5 g/dL - 15.8 g/dL) recently defined for East and Southern Africa. CONCLUSION: The established values provide an important tool for patient management and could influence decisions on inclusion of participants and adverse events in clinical trials conducted locally.

Impact of Mentorship on WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA)

Background: The improvment of the quality of testing services in public laboratories is a high priority in many countries. Consequently; initiatives to train laboratory staff on quality management are being implemented; for example; the World Health Organization Regional Headquarters for Africa (WHO-AFRO) Strengthening Laboratory Management Towards Accreditation (SLMTA). Mentorship may be an effective way to augment these efforts.Methods: Mentorship was implemented at four hospital laboratories in Lesotho; three districts and one central laboratory; between June 2009 and December 2010. The mentorship model that was implemented had the mentor fully embedded within the operations of each of the laboratories. It was delivered in a series of two mentoring engagements of six and four week initial and follow-up visits respectively. In total; each laboratory received 10 weeks mentorship that was separated by 6-8 weeks. Quality improvements were measured at baseline and at intervals during the mentorship using the WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist and scoring system. Results: At the beginning of the mentorship; all laboratories were at the SLIPTA zero star rating. After the initial six weeks of mentorship; two of the three district laboratories had improved from zero to one (out of five) star although the difference between their baseline (107.7) and the end of the six weeks (136.3) average scores was not statistically significant (p = 0.25). After 10 weeks of mentorship there was a significant improvement in average scores (182.3; p = 0.034) with one laboratory achieving WHO-AFRO three out of a possible five star status and the two remaining laboratories achieving a two star status. At Queen Elizabeth II (QE II) Central Laboratory; the average baseline score was 44; measured using a section-specific checklist. There was a significant improvement by five weeks (57.2; p = 0.021). Conclusion: The mentorship programme in this study resulted in significant measurable improvements towards preparation for the WHO-AFRO SLIPTA process in less than six months. We recommend that mentorship be incorporated into laboratory quality improvement and management training programmes such as SLMTA; in order to accelerate the progress of laboratories towards achieving accreditation

Strengthening laboratory management towards accreditation: the Lesotho experience

Introduction: The Lesotho Ministry of Health and Social Welfare's (MOHSW) 5-year strategic plan; as well as their national laboratory policy and yearly operational plans; directly addresses issues of accreditation; indicating their commitment to fulfilling their mandate. As such; the MOHSW adopted the World Health Organization Regional Headquarters for Africa's Stepwise Laboratory Quality Improvement Toward Accreditation (WHO-AFRO-SLIPTA) process and subsequently rolled out the Strengthening Laboratory Management Towards Accreditation (SLMTA) programme across the whole country; becoming the first African country to do so. Methods: SLMTA in Lesotho was implemented in two cohorts. Twelve and nineteen laboratory supervisors and quality officers were enrolled in Cohort 1 and Cohort 2; respectively. These 31 participants represented 18 of the 19 laboratories nationwide. For the purposes of this programme; the Queen Elizabeth II (QE II) Central Laboratory had its seven sections of haematology; blood bank; cytology; blood transfusion; microbiology; tuberculosis laboratory and chemistry assessed as separate sections. Performance was tracked using the WHO-AFRO-SLIPTA checklist; with assessments carried out at baseline and at the end of SLMTA. Two methods were used to implement SLMTA: the traditional 'three workshops' approach and twinning SLMTA with mentorship. The latter; with intensive follow-up visits; was concluded in 9 months and the former in 11 months. A standard data collection tool was used for site visits.Results: Of the 31 participants across both cohorts; 25 (81) graduated (9 from Cohort 1 and 16 from Cohort 2). At baseline; all but one laboratory attained a rating of zero stars; with the exception attaining one star. At the final assessment; 7 of the 25 laboratories examined at baseline were still at a rating of zero stars; whilst 8 attained one star; 5 attained two stars and 4 attained three stars. None scored above three stars. The highest percentage improvement for any laboratory was 51; whereas the least improved dropped by 6 when compared to its baseline assessment.The most improved areas were corrective actions (34) and documents and records (32). Process improvement demonstrated the least improvement (10). Conclusion: The SLMTA programme had an immediate; measurable and positive impact on laboratories in Lesotho. This success was possible because of the leadership and ownership of the programme by the MOHSW; as well as the coordination of partner support

Quantitation of human immunodeficiency virus type 1 viral load in plasma using reverse transcriptase activity assay at a district hospital laboratory in Botswana: a decentralization pilot study.

Roche COBAS Amplicor monitor version 1.5 assay is considered gold standard for viral load monitoring in Botswana. Due to its demand for elaborate infrastructure, viral load testing has been confined to the national HIV reference laboratories. Cavidi ExaVir Load version 2 assay was considered as a potential alternative to decentralize viral load testing to the rural/remote hospital laboratories and thus increase access to therapy. This study compared the performance of ExaVir Load v2 assay at a district hospital laboratory in Serowe and COBAS Amplicor monitor v1.5 assay at the Botswana Harvard HIV Reference Laboratory using quality assessment samples and plasma from HIV-positive individuals. ExaVir Load v2 and COBAS Amplicor monitor v1.5 assays had very good agreement; Kappa statistic 0.951. The COBAS Amplicor monitor v1.5 and ExaVir Load v2 assays detected HIV-1 RNA in 84 and 86 samples but did not detect HIV-1 RNA in 221 and 219 samples, respectively. The two assays detected HIV-1 RNA concordantly in 82 samples and were strongly correlated (r=0.8554, P<0.0001). ExaVir Load v2 assay provided a simple and reliable alternative viral load system that is adaptable to district hospital laboratories. The cost per test is less than RT-PCR. The ExaVir Load v2 systems have since been placed in four more district and primary hospital laboratories.