This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
This Medical Product Alert relates to the recent circulation of two confirmed falsified versions of Quinine
Sulphate circulating in Cameroon and the Democratic Republic of the Congo, containing zero active
pharmaceutical ingredient
The aim of the Annual Inspection Report is to present findings of public sector health establishments inspected by the OHSC to monitor compliance with the National Core Standards (NCS) during the 2016/2017 financial year in South Africa.
The NCS define fundamentals for quality of care based on six ...dimensions of quality: Acceptability,Safety, Reliability, Equity, Accessibility, and Efficiency.
The NCS structured assessment tools were used to collect data during inspections across the seven domains namely: Patient Rights; Patient Safety, Clinical Governance and Clinical Care; Clinical Support Services; Public Health; Leadership and Governance; Operational Management and Facilities and Infrastructure. A total of 851 routine inspections were conducted with 201 of these facilities re-inspected. Inspection data was captured on District Health Information System (DHIS) data entry forms and exported for analysis to Statistical Analysis Software (SAS) version 9.4.
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Transforming the Quality of Health Care in Ethiopia
A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens and for the examination of sputum smears by direct microscopy. This edition incl...udes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.
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The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information... on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
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Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis.
Accessed in November 2017.
Three Years After Enactment of the Drug Quality and Security Act
Antibiotics 2022, 11(3), 329; https://doi.org/10.3390/antibiotics11030329.
The authors found that the most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate ...deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.
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Thesis presented in partial fulfilment of the requirements for the degree of Master of Nursing Science in the Faculty of Health Sciences at Stellenbosch University.
The mobile clinic health care services fulfil an essential role in delivering primary health care to the dwellers in the rural commun...ities of the Western Cape. However, occupational health and safety, as well as quality assurance are issues that need to be addressed urgently. It is thus recommended that policy makers take cognizance of the specific needs of every individual mobile clinic team.
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This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
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The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the M...UL_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
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The WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS) was launched in 2015 to foster AMR surveillance and inform strategies to contain AMR. The system started with surveillance of AMR in bacteria causing common human infections and has expanded its scope to include surveillance... of antimicrobial consumption (AMC), invasive fungal infections, and a One Health surveillance model relevant to human health. To meet future challenges, it is in continuous evolution to enhance the quality and representativeness of data to inform the AMR burden accurately. As of the end of 2022, 127 countries, territories and areas participate in GLASS.
The fifth GLASS report, produced in collaboration with Member States, summarizes 2020 data on AMR rates in common bacteria from countries, territories, and areas. The report brings new features, including analyses of population testing coverage or AMR trends. For the first time, the report presents 2020 data on AMC at the national level. A new interactive dashboard allow users to explore AMR and AMC global data, country profiles and download the data.
This report marks the end of the early implementation phase of GLASS. In addition to presenting data collected through the latest data call, this report provides a summary of five years of national AMR surveillance data contributed to GLASS from its initiation, presents AMR findings in the context of progress of country participation in GLASS and in global AMR surveillance coverage and laboratory quality assurance systems at (sub)national level.
Patterns of antimicrobial consumption are presented by country with a particular focus on antibacterials. The report also presents the antimicrobial consumption according to the WHO AWaRe antibiotic classification, for penicillins and cephalosporines. From a One Health perspective, the report presents antimicrobial consumption data in the human sector expressed in tons to allow a comparison with antimicrobial consumption from other sectors (not included in this report).
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What are the FP and CAC competencies?
Through the clear articulation of the family planning and comprehensive abortion care (FP and CAC) competencies for the primary health care workforce, the aim is to advance improvements in FP and CAC service delivery by aligning health worker education approach...es with population health needs and health system demands.
This document, which describes these competencies in detail, is intended to:
be a foundational tool to be adopted and adapted by educators and regulators for FP and CAC providers (students) with a pre-service training pathway of at least 12 months;
describe competencies that are relevant to current and future health practice;
enable widespread use of the competencies not only for curriculum development for pre-service education, but also for in-service education, regulation, qualifications, quality assurance, personal development, performance evaluation, recruitment, management and career progression;
focus on the core functions of FP and CAC providers within broader efforts towards achieving universal health coverage
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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HIV testing programmes need to ensure that all clients who test for HIV are provided with correct diagnoses. The accuracy of HIV testing is critical to prevent misdiagnosis, as the consequences of giving an incorrect test result can be serious for clients, HIV testing services, HIV programmes and pu...blic health.
With the evolution of global HIV epidemiology, HIV testing approaches must also evolve to maintain accuracy and efficiency in population-level diagnosis. Reports suggest that misdiagnosis of HIV status may occur when suboptimal testing algorithms and out-of-date testing strategies are used. As a result of changing epidemiology and declining HIV positivity in testing, WHO recommends all countries use a standard three-test strategy to ensure a PPV of at least 99%, minimizing false-positive misdiagnosis. The WHO-recommended HIV testing strategy, along with quality assurance measures such as retesting to verify a positive diagnosis prior to initiation of HIV treatment, is cost-effective as it prevents misdiagnosis and unnecessary initiation of costly lifelong treatment.
This implementation guide provides practical advice on switching to a three-test strategy and instituting other measures that can help national HIV programmes deliver high-quality, accurate HIV testing services and ensure that misdiagnosis is minimized.
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