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Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research.

ABSTRACT: Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of GCLP at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

SUBMITTER: Gumba H

PROVIDER: S-EPMC6305232 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundLimited health research capacities (HRC) undermine a country's ability to identify and adequately respond to local health needs. Although numerous interventions to strengthen HRC have been conducted in Africa, there is a need to share the lessons learnt by funding organizations, institutes and researchers. The aim of this report is to identify best practices in HRC strengthening by describing a training programme conducted between 2016 and 2017 at the Saint Joseph's Catholic Hospital (SJCH) in Monrovia (Liberia).MethodsA call for trainees was launched at the SJCH, the Liberia Medicines and Health Products Regulatory Authority (LMHRA), the Ministry of Health and Social Welfare, the Mother Pattern College of Health Sciences (MPCHS) and community members. Selected trainees participated in four workshops on Good Clinical Laboratory Practice (GCLP), standard operating procedures (SOP) and scientific communication, as well as in a 5-months eLearning mentoring programme. After the training, a collectively-designed research project on malaria was conducted.ResultsTwenty-one of the 28 trainees (14 from the SJCH, 3 from LMHRA, one from MPCHS, and 10 community representatives) completed the programme satisfactorily. Pre- and post-training questionnaires completed by 9 of the trainees showed a 14% increase in the percentage of correct answers. Trainees participated in a mixed-methods cross-sectional study of Plasmodium falciparum infection among pregnant women at the SJCH. Selected trainees disseminated activities and research outcomes in three international meetings and three scientific publications.ConclusionThis training-through-research programme successfully involved SJCH staff and community members in a practical research exercise on malaria during pregnancy. The challenge is to ensure that the SJCH remains active in research. Harmonization of effectiveness indicators for HRC initiatives would strengthen the case for investing in such efforts.

Project description:BackgroundCancer-related fatigue (CRF) is a key concern for people living with cancer and can impair physical functioning and activities of daily living. Evidence-based guidelines for CRF are available, yet inconsistently implemented globally. This study aimed to identify barriers and enablers to applying a cancer fatigue guideline and to derive implementation strategies.MethodsA mixed-method study explored the feasibility of implementing the CRF guideline developed by the Canadian Association for Psychosocial Oncology (CAPO). Health professionals, managers and consumers from different practice settings participated in a modified Delphi study with two survey rounds. A reference group informed the design of the study including the surveys. The first round focused on guideline characteristics, compatibility with current practice and experience, and behaviour change. The second survey built upon and triangulated the first round.ResultsForty-five health practitioners and managers, and 68 cancer survivors completed the surveys. More than 75% of participants endorsed the CAPO cancer related fatigue guidelines. Some respondents perceived a lack of resources for accessible and expert fatigue management services. Further barriers to guideline implementation included complexity, limited practical details for some elements, and lack of clinical tools such as assessment tools or patient education materials. Recommendations to enhance guideline applicability centred around four main themes: (1) balancing the level of detail in the CAPO guideline with ease of use, (2) defining roles of different professional disciplines in CRF management, (3) how best to integrate CRF management into policy and practice, (4) how best to ensure a consumer-focused approach to CRF management.ConclusionsTranslating current knowledge on optimal management of CRF into clinical practice can be enhanced by the adoption of valid guidelines. This study indicates that it is feasible to adopt the CAPO guidelines. Clinical application may be further enhanced with guideline adaptation, professional education and integration with existing practices.

Project description:Background: Strengthening capacity for public health research is essential to the generation of high-quality, reliable scientific data. This study focuses on a research capacity strengthening project supporting seven test facilities in Africa conducting studies on mosquito vector control products towards Good Laboratory Practice (GLP) certification. It captures the primary effects of the project on each facility's research capacity, the secondary effects at the individual and institutional level, and the ripple effects that extend beyond the research system. The relationships between effects at different levels are identified and compared to an existing framework for the evaluation of research capacity strengthening initiatives. Methods: To capture the views of individuals engaged in the project at all levels within each facility, a maximum-variation purposive sampling strategy was used. This allowed triangulation between different data sources. Semi-structured interviews were conducted with individuals in three facilities and a combination of email and remote video-call interviews were conducted with individuals at two further facilities. Results: We found that, despite a focus of the GLP certification project at the institutional level, the project had effects also at individual (including enhanced motivation, furtherment of careers) and national/international levels (including development of regional expertise). In addition, we detected ripple effects of the project which extended beyond the research system. Conclusion: This study shows that research capacity strengthening interventions that are focussed on institutional level goals require actions also at individual and national/international levels. The effects of engagement at all three levels can be amplified by collaborative actions at the national/international level. These findings show that research capacity strengthening projects must develop plans that address and evaluate impact at all three levels. Capturing the ripple effects of investment in research capacity strengthening should also be planned for from the beginning of projects to support further engagement of all stakeholders.

Project description:Background: With increasing insecticide resistance in malaria-endemic countries there is an urgent need for safe and effective novel vector control products. To improve the capacity of facilities that test insecticides in sub-Saharan Africa, a programme is supporting seven facilities towards Good Laboratory Practice (GLP) certification, the globally recognized standard for quality management system (QMS) for the conduct of non-clinical and environmental studies. The World Health Organization (WHO) GLP Handbook provides guidance on a stepwise approach to implement a GLP compliant QMS. This study assesses auditor GLP checklists and timings outlined in the WHO GLP Handbook in the real-life context of a Tanzanian insecticide-testing facility, evaluating their implementation in this context. Methods and Principle Findings: We conducted document review and semi-structured interviews with staff at all levels of the test facility to explore factors that influenced progress towards GLP certification. We found that while auditor GLP checklists underemphasised computer systems, they were otherwise broadly applicable. Factors that delayed time to completion of GLP certification included the need for extensive infrastructure improvements, the availability of regional expertise related to GLP, the capacity of national and regional external systems and services to meet GLP compliance requirements, and training development required for Standard Operating Procedure implementation. Conclusion: The standards required for full GLP compliance are rigorous, with an expected completion timeline to implementation of 24 months. This study shows that in low and middle-income countries this timeline may be unrealistic due to challenges related to infrastructure development and lack of regional capacity and expertise. We recommend a comprehensive gap analysis when starting a project, including these areas which are beyond those recommended by the WHO GLP Handbook. These challenges can be successfully overcome and the experience in Tanzania provides key lessons for other facilities seeking GLP certification or the development of similar QMS.

Project description:BackgroundEvery week, radiotherapy centers face the complex task of scheduling hundreds of treatment sessions amongst the available linear accelerators. With the increase in cancer patient numbers, manually creating a feasible and efficient schedule has shown to be a difficult, time-consuming task. Although operations research models have been increasingly reported upon to optimize patient care logistics, there is almost no scientific evidence of implementation in practice.MethodsA mathematical operations research model was adapted to generate radiotherapy treatment schedules in two Dutch centers. The model was iteratively adjusted to fulfill the technical and medical constraints of each center until a valid model was attained. Patient data was collected for the planning horizon of one week, and the feasibility of the obtained schedules was verified by the staff of each center. The resulting optimized solutions are compared with the ones manually developed in practice.ResultsThe weekly schedule was improved in both centers by decreasing the average standard deviation between sessions' starting times from 103.0 to 50.4 minutes (51%) in one center, and the number of gaps in the schedule from 18 to 5 (72%) in the other. The number of patients requiring linac switching between sessions has also decreased from 71 to 0 patients in one center, and from 43 to 2 in the other. The automated process required 5 minutes and 1.5 hours of computation time to find an optimal weekly patient schedule, respectively, as opposed to approximately 1.5 days when performed manually for both centers.ConclusionsThe practical application of a theoretical operations research model for radiotherapy treatment scheduling has provided radiotherapy planners a feasible, high-quality schedule in an automated way. Iterative model adaptations performed in small steps, early engagement of stakeholders, and constant communication proved to facilitate the implementation of operations research models into clinical practice.

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Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research.

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