Global laboratory initiative tool for a stepwise process towards tuberculosis laboratory accreditation [Correspondence]

Datema, Tjeerd; Oskam, Linda; Engelberts, Mirjam F. M.; Beers, Stella M. van; Shinnick, Thomas M.; Baker, Martin; Ridderhof, John C.; Scholten, J; Deun, Armand Van; Gilpin, Christopher; Klatser, Paul

doi:10.5588/ijtld.11.0701

Cited by 10 publications

(7 citation statements)

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“…This scoping study developed an unbiased and comprehensive way of identifying potential NTD reference laboratories in the five WHO regions – Americas, Eastern Mediterranean, Europe, South-East Asia and Western Pacific. As there was no pre-existing definition of an ‘NTD reference laboratory’, we extracted information from published literature 13– 17 about the laboratory characteristics needed to fulfil diagnostic, research, supervision, training, quality, and networking requirements of a national or regional reference laboratory for NTDs, and verified them with NTD control programme specialists. These characteristics were:…”

Section: Methodsmentioning

confidence: 99%

Establishing an international laboratory network for neglected tropical diseases: Understanding existing capacity in five WHO regions

et al. 2018

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Background. Limited laboratory capacity is a significant bottleneck in meeting global targets for the control and elimination of neglected tropical diseases (NTD). Laboratories are essential for providing clinical data and monitoring data about the status and changes in NTD prevalence, and for detecting early drug resistance. Currently NTD laboratory networks are informal and specialist laboratory expertise is not well publicised, making it difficult to share global expertise and provide training, supervision, and quality assurance for NTD diagnosis and research. This study aimed to identify laboratories within five World Health Organisation regions (South-East Asia, Eastern Mediterranean, Americas, Western Pacific and Europe) that provide NTD services and could be regarded as national or regional reference laboratories, and to conduct a survey to document their networks and capacity to support NTD programmes. Methods. Potential NTD reference laboratories were identified through systematic searches, snowball sampling and key informants. Results. Thirty-two laboratories responded to the survey. The laboratories covered 17 different NTDs and their main regional and national roles were to provide technical support and training, research, test validation and standard setting. Two thirds of the laboratories were based in academic institutions and almost half had less than 11 staff. Although greater than 90 per cent of the laboratories had adequate technical skills to function as an NTD reference laboratory, almost all laboratories lacked systems for external verification that their results met international standards. Conclusions. This study highlights that although many laboratories believed they could act as a reference laboratory, only a few had all the characteristics required to fulfil this role as they fell short in the standard and quality assurance of laboratory processes. Networks of high quality laboratories are essential for the control and elimination of disease and this study presents a critical first step in the development of such networks for NTDs.

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Section: Methodsmentioning

confidence: 99%

Establishing an international laboratory network for neglected tropical diseases: Understanding existing capacity in five WHO regions

et al. 2018

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show abstract

“…This scoping study developed an unbiased and comprehensive way of identifying potential NTD reference laboratories in the five WHO regions -Americas, Eastern Mediterranean, Europe, South-East Asia and Western Pacific. As there was no preexisting definition of an 'NTD reference laboratory', we extracted information from published literature [13][14][15][16][17] about the laboratory characteristics needed to fulfil diagnostic, research, supervision, training, quality, and networking requirements of a national or regional reference laboratory for NTDs, and verified them with NTD control programme specialists. These characteristics were:…”

Section: Methodsmentioning

confidence: 99%

Establishing an international laboratory network for neglected tropical diseases: Understanding existing capacity in five WHO regions

et al. 2018

View full text Add to dashboard Cite

Background. Limited laboratory capacity is a significant bottleneck in meeting global targets for the control and elimination of neglected tropical diseases (NTD). Laboratories are essential for providing clinical data and monitoring data about the status and changes in NTD prevalence, and for detecting early drug resistance. Currently NTD laboratory networks are informal and specialist laboratory expertise is not well publicised, making it difficult to share global expertise and provide training, supervision, and quality assurance for NTD diagnosis and research. This study aimed to identify laboratories within five World Health Organisation regions (South-East Asia, Eastern Mediterranean, Americas, Western Pacific and Europe) that provide NTD services and could be regarded as national or regional reference laboratories, and to conduct a survey to document their networks and capacity to support NTD programmes. Methods. Potential NTD reference laboratories were identified through systematic searches, snowball sampling and key informants. Results. Thirty-two laboratories responded to the survey. The laboratories covered 25 different NTDs and their main regional and national roles were to provide technical support and training, research, test validation and standard setting. Two thirds of the laboratories were based in academic institutions and almost half had less than 11 staff. Although greater than 90 per cent of the laboratories had adequate technical skills to function as an NTD reference laboratory, almost all laboratories lacked systems for external verification that their results met international standards. Conclusions. This study highlights that although many laboratories believed they could act as a reference laboratory, only a few had all the characteristics required to fulfil this role as they fell short in the standard and quality assurance of laboratory processes. Networks of high quality laboratories are essential for the control and elimination of disease and this study presents a critical first step in the development of such networks for NTDs.

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“…From this information we were able to generate a list of all the components that were necessary for an optimal laboratory system in the domain of NTDs and used this to inform the design of our tools. Specifically, the following documents guided the development of our assessment and monitoring tools; the Global Laboratory Initiative Stepwise Process towards TB Laboratory Accreditation [13] and adapted for NTD laboratories, the EFQM excellence model [14] , the SIDA evaluation model of HEPNet [15] and the UNDP Measuring Capacity document [16] . Using all the components in the list of optimal capacities we developed a questionnaire for laboratory managers, a semi-structured interview guide for use with laboratory stakeholders, a capacity gap checklist for use with the laboratory manager and laboratory staff, and a checklist for ISO 15189 to be used for on-site observations (see Table 2 ).…”

Section: Methodsmentioning

confidence: 99%

“…The ISO checklist is completed with the laboratory manager and safety and quality officers to identify specific gaps to overcome in the short term, and what is required in the longer term to achieve ISO 15189 accreditation. This checklist is derived from the WHO laboratory quality management system training toolkit [17] and the Global Laboratory Initiative (GLI) Stepwise Process towards TB Laboratory Accreditation [13] . The GLI process is specifically targeted at tuberculosis reference laboratories so some of the specific content required changing to be relevant to NTDs.…”

Section: Methodsmentioning

confidence: 99%

A Systematic Approach to Capacity Strengthening of Laboratory Systems for Control of Neglected Tropical Diseases in Ghana, Kenya, Malawi and Sri Lanka

et al. 2014

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BackgroundThe lack of capacity in laboratory systems is a major barrier to achieving the aims of the London Declaration (2012) on neglected tropical diseases (NTDs). To counter this, capacity strengthening initiatives have been carried out in NTD laboratories worldwide. Many of these initiatives focus on individuals' skills or institutional processes and structures ignoring the crucial interactions between the laboratory and the wider national and international context. Furthermore, rigorous methods to assess these initiatives once they have been implemented are scarce. To address these gaps we developed a set of assessment and monitoring tools that can be used to determine the capacities required and achieved by laboratory systems at the individual, organizational, and national/international levels to support the control of NTDs.Methodology and principal findingsWe developed a set of qualitative and quantitative assessment and monitoring tools based on published evidence on optimal laboratory capacity. We implemented the tools with laboratory managers in Ghana, Malawi, Kenya, and Sri Lanka. Using the tools enabled us to identify strengths and gaps in the laboratory systems from the following perspectives: laboratory quality benchmarked against ISO 15189 standards, the potential for the laboratories to provide support to national and regional NTD control programmes, and the laboratory's position within relevant national and international networks and collaborations.ConclusionWe have developed a set of mixed methods assessment and monitoring tools based on evidence derived from the components needed to strengthen the capacity of laboratory systems to control NTDs. Our tools help to systematically assess and monitor individual, organizational, and wider system level capacity of laboratory systems for NTD control and can be applied in different country contexts.

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Global laboratory initiative tool for a stepwise process towards tuberculosis laboratory accreditation [Correspondence]

Cited by 10 publications

References 0 publications

Establishing an international laboratory network for neglected tropical diseases: Understanding existing capacity in five WHO regions

Establishing an international laboratory network for neglected tropical diseases: Understanding existing capacity in five WHO regions

Establishing an international laboratory network for neglected tropical diseases: Understanding existing capacity in five WHO regions

A Systematic Approach to Capacity Strengthening of Laboratory Systems for Control of Neglected Tropical Diseases in Ghana, Kenya, Malawi and Sri Lanka

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