Assessing operational readiness: Regulatory landscape and compliance in zimbabwe for medical devices and in vitro diagnostic medical devices.

The regulation of medical devices and In Vitro Diagnostic (IVD) medical devices have lagged significantly, especially in low- and middle-income countries. Disparities in regulating medical and IVD medical devices in Africa are below the global average. This may translate to poor access to quality-assured medical and IVD devices, resulting in undesirable health outcomes. Operational readiness to regulate medical and IVD devices at the Medicines Control Authority of Zimbabwe (MCAZ) was assessed. The aim was to determine the strengths and gaps and propose an action plan that can be monitored and evaluated to assess progress over time. We used the World Health Organization (WHO) Global Benchmarking Tool for medical devices and IVDs methodology to evaluate regulatory oversight of these products. Purposive sampling was used for data collection using researcher-administered global benchmarking tool factsheets and document reviews to evaluate the implementation of the regulatory functions. The regulatory functions assessed were the National Regulatory System, Registration and Market Authorization, Vigilance, Market Surveillance and Control, Licensing Establishment, Regulatory Inspection, Laboratory Testing, and Clinical Trials Oversight. The MCAZ attained maturity level 1, with a regulatory system score of 79%, registration and market authorization 44%, vigilance 27%, market surveillance and control 40%, licensing establishment 62%, regulatory inspection 68%, laboratory testing 88%, and clinical trials 18%. Condoms and gloves were the only regulated medical devices in Zimbabwe. IVDs were not regulated by the MCAZ. This review showed that the regulatory system is not robust, fit for purpose, responsive, transparent, or proportionate to the risk classification of medical devices and IVDs. It is crucial to amend the Medicines and Allied Substance Control Act to incorporate the definition and classification of medical devices and IVDs, regulatory authority establishment, licensing and registration, quality management system, conformity assessment, post-market surveillance, labeling and instructions for use, capacity building and training, and international harmonization

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

Genexpert MTB/RIF diagnostic and tuberculosis treatment initiation delays in Namibia

BACKGROUND : Early diagnosis and treatment of drug resistant tuberculosis are crucial in the control of the disease and treatment success. In Namibia, there is a gap in empirical data on the diagnosis and treatment initiation delay time since the roll-out of the GeneXpert MTB/RIF (Xpert) assay in 2017. This study aimed to determine Xpert pre-diagnosis and turnaround time at Namibian Institute of Pathology (NIP) as well as rifampicin resistant tuberculosis (RR-TB) treatment initiation delay on patients admitted at Katutura Intermediate Hospital TB clinic. METHODS : This was retrospective descriptive cross-sectional study which was conducted from 1 July 2018 to 31 March 2019. A total of seventy two participants comprising of twenty five RR-TB and forty seven non RR-TB patients were enrolled using consecutive sampling method. Laboratory information system (LIS) was utilized to determine Xpert median pre-analytical delay and turnaround time. Patients’ records and LIS were used to calculate median treatment initiation delay time post Xpert diagnosis. Data on continuous variables was summarized as median and interquartile range. RESULTS : The median pre-diagnostic, diagnostic and treatment initiation delay time were 7.5 (IQR: 0-14), 1 (IQR: 0-3) and 10 (IQR: 1-32) days respectively for RR-TB. For drug susceptible TB, the median pre-diagnostic, diagnostic and treatment initiation delay time were 5 (IQR: 1-8), 1 (IQR: 0-3) and 3 (IQR: 0-12) days respectively. Overall, median health system delay time was 21 (IQR: 2-32) days for RR-TB patients and 12 (IQR: 1-12) days for non RR-TB patients. CONCLUSION : Treatment initiation to appropriate second line regimes was long for many patients and may be attributable to poor interpretation of discordant results and increased number of RR-TB patients for treatment since Xpert adoption. Unnecessary referrals due to shortages of pulmonologists, cumbersome baseline investigations and outdated guidelines and policies could be the determinants of health system delay time. Interventions targeted at addressing identified factors should be implemented. Further studies should explore the actual treatment gap among RR-TB patients and further risk factors for delayed treatment.https://www.wjahr.comam2020School of Health Systems and Public Health (SHSPH

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

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

Navigating regulatory landscape: A qualitative exploration of medical devices and in vitro diagnostic medical devices oversight in Zimbabwe through key stakeholder perspectives.

Medical devices and In Vitro Diagnostics (IVDs) are vital for public health and accessible healthcare. Still, there is an imbalance in high-quality products in Low and Middle-Income Countries (LMICs). Zimbabwe's regulatory framework for medical devices and IVDs is unclear, leading to ineffective compliance and surveillance. As a result, there are knowledge gaps regarding pre-market and post-market regulatory elements to ensure the safety, quality and performance of medical devices and IVDs used in Zimbabwe. Our study aimed to explore the current status of medical devices and IVD regulations in Zimbabwe. Semi-structured interviews were conducted with 12 regulators from the Medicines Control Authority of Zimbabwe (MCAZ) National Microbiology Reference Laboratory (NMRL), Medical Laboratory and Clinical Scientists Council (MLCScCZ) to understand the current status of medical devices and IVD regulations in Zimbabwe. Three participants completed a questionnaire to understand the regulatory landscape in Zimbabwe. Three key informant interviews were conducted with three regulators from the South African Health Products Regulatory Authority (SAHPRA), Tanzanian Medicines and Medical Devices Authority (TMDA), and World Health Organization Regulatory Systems Strengthening (WHO RSS) to learn best practices to create a roadmap for Zimbabwe. We analyzed qualitative data using a thematic analysis. The findings reveal significant deficiencies and gaps in the legal framework for regulating medical devices and IVDs, highlighting the need for a legal framework and the absence of more comprehensive regulations. Regulatory entities face capacity limitations, especially in regulating medical devices and IVDs. Conformity assessment processes, medical devices, IVD classification criteria, and post-market surveillance also represent challenges, highlighting the need for a well-defined framework and regulatory procedures. The Zimbabwean regulatory system pathway is reactive, prompting several regulatory initiatives to address needs. Despite facing challenges, there is recognition of the importance of collaboration among regulatory authorities, emphasizing a shared commitment to improving and strengthening medical devices and IVD regulations for improved patient safety. By advocating for a proactive, comprehensive, and legally sound approach, indicating the potential for collaboration and synergy, this study provides a foundation for well-informed policy recommendations to guide enhancements and build a framework for a resilient, efficient, and transparent regulatory environment in the Zimbabwe and African regions as a whole

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

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

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

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