| Literature DB >> 33263036 |
Riccardo Alagna1, T Léon Sawadogo2, Elisa Tagliani1, Adjima Combary2, Daniela Maria Cirillo1.
Abstract
GeneXpert scale-up is a historic step in the process of tuberculosis (TB) elimination. However, the global roll-out of the test has highlighted gaps that have limited its impact on the TB care cascade. Here we report the description of an innovative GeneXpert network strengthening tool called Applying a Standardized Approach to Strengthen Performances of GeneXpert Networks (ASAP-GxNet) and highlight results and challenges during implementation of the pilot in Burkina Faso. ASAP-GxNet is a 6-month competency-based programme involving an innovative GeneXpert assessment tool as well as a series of short courses and projects designed to qualitatively improve the network while strengthening the capacity of the national GeneXpert focal point to oversee the network. Progress of the GeneXpert network is measured before and at the end of the programme and is rated using a star system (0 to 4 stars). In Burkina Faso, implementation of the ASAP-GxNet programme resulted in improved management of the national GeneXpert network with a 21% increase in points from the start to the end of the programme. To our knowledge, ASAP-GxNet is the first programme to give an overall picture of the quality of GeneXpert networks and to investigate performance in terms of management behaviour. ASAP-GxNet has been developed to help national TB programmes coordinate efforts and needs and highlights the expected achievements of the GeneXpert network.Entities:
Year: 2020 PMID: 33263036 PMCID: PMC7682669 DOI: 10.1183/23120541.00283-2020
Source DB: PubMed Journal: ERJ Open Res ISSN: 2312-0541
FIGURE 1Applying a Standardized Approach to Strengthen Performances of GeneXpert Networks (ASAP-GxNet) implementation process. M&E: montoring and evaluation.
Areas, core capacities and components evaluated by the standardised assessment tool
| 1. Governance | Governance, national policies and plan, financing, algorithm, specimen referral system | 15 | |
| 2. Coverage | GeneXpert integration, current GeneXpert coverage, future GeneXpert coverage | 9 | |
| 3. Installation roadmap | Pre-installation, installation, post-installation | 9 | |
| 4. Maintenance | Warranty; calibration, service interruption | 9 | |
| 5. Data management | Sample data management, data analysis, reporting | 9 | |
| 6. Supply chain management | Forecast, procurement, distribution, stock management, service interruption | 15 | |
| 7. Workforce | Network management, training | 6 | |
| 8. Quality assurance | Quality assurance, external quality assurance | 6 | |
| 9. Quality indicators | Diagnostic cascade quality indicators, performance quality indicators | 12 | |
| 10. Management | National policies and plan, algorithm, financing, coverage, pre-installation, installation, post-installation, warranty, calibration, data management, forecast, procurement, stock management, training, quality | 45 | |
| 135 |
GeneXpert network “Star rating”: “0 stars” (0–27 points, <20%); “1 star” (28–54 points, 20–40%); “2 stars” (55–81 points, 40–60%); “3 stars” (82–108 points, 60–80%); “4 stars” (109–135 points, 80–100%).
FIGURE 2Standardised assessment tool structure and colour-coded visualisation of core capacities results. a) Structure of standardised assessment tool with questions defining components and core capacities. b) Colour-coded visualisation of core capacities: Black “0 point”, Red “1 point”, Yellow “2 points”, Green “3 points”.
FIGURE 3Performance of various core capacities, as measured by the Applying a Standardized Approach to Strengthen Performances of GeneXpert Networks (ASAP-GxNet) assessment tool from baseline to exit audit.
Selection of questions with improved results from baseline to exit assessment and related actions
| 9/15 | 11/15 (91%) | Financing | Is there any instrument to estimate costs related to instrument purchase and implementation? | No tool available | Tool available and used Budget aligned with operational plan | Training on the use of ASAP-GxNet financing tool | |
| Are costs for cartridge procurement estimated? | Detailed cost estimation is available but not aligned with operational plan | Detailed cost estimation is available and aligned with operational plan | Training on cartridges quantification | ||||
| Algorithm | Does the algorithm address the laboratory goals of the End TB strategy to increase access to rapid and accurate detection of TB and to reach universal access to DST? | The national algorithm incorporates the use of WHO-approved rapid diagnostics (WRDs) for all patients in all high-priority groups ( | The national algorithm incorporates universal access to WRDs for all patients and all persons being evaluated for TB | Improvements not dependent by ASAP-GxNet | |||
| Specimen referral system | Is there a national TB specimen referral and transportation strategy? | There is a TB specimen referral and transportation strategy approved | There is an integrated specimen referral and transportation strategy approved | Improvements not dependent by ASAP-GxNet | |||
| 5/9 | 6/9 (67%) | Current GeneXpert coverage | Is an evidence-based method used to estimate the future needs of GeneXpert instruments? | Estimation is based on detailed evidence | Estimation is based on detailed evidence | Improvement projects on “development of a document for identification of network needs” | |
| 4/9 | 6/9 (67%) | Pre-installation | Is the selection of new GeneXpert sites based on standardised criteria? | New sites are selected by geographical reasons only | A documented list of criteria, including geographical, epidemiological and infrastructural information, is described in the Xpert implementation plan and used to select new sites | Improvement projects on “development of a document for identification of network needs” and | |
| Is a standardised checklist available and used to evaluate the site prior to installation? | A standardised checklist is available and used but not detailed | A standardised checklist is available and used to evaluate the site prior installation. In line with FIND checklist template | Improvement project to revise and update national document | ||||
| Installation | Is a standardised checklist available and used to evaluate the instrument installation? | A standardised checklist is available and used but not detailed | A standardised checklist is available and used to evaluate the site prior installation. In line with FIND checklist template | Improvement project to revise and update national document | |||
| Post-installation | Is a standardised checklist available and used to evaluate GeneXpert sites? | A standardised checklist is available and used but not detailed | A standardised checklist is available and used to evaluate the site. In line with FIND checklist template | Improvement project to revise and update national document | |||
| 6/9 | 7/9 (78%) | Warranty | Is there a mechanism in place to monitor GeneXpert instrument repairs at testing sites? | Yes, but the current mechanism is not functional | Yes, but it functions well only at some testing sites | Improvement project on implementation of Xpert tracking tool | |
| Calibration | Are all GeneXpert instruments calibrated every year? | Some GeneXpert instruments are calibrated every year with delay | All GeneXpert instruments are calibrated in due time | Improvement project on implementation of Xpert tracking tool | |||
| Service interruption | Is a back-up plan (including SOPs) available in case of service interruption due to equipment failure for handling specimens during these times, identification of referral laboratory for testing and referral procedures? | Only | Back-up plan (including SOPs) is available but not applied for handling specimens during service interruption due to equipment failure | Improvement project to develop a back-up plan for all GeneXpert sites | |||
| 4/9 | 7/9 (78%) | Sample data management | Is there any connectivity system for Xpert MTB/RIF(-ULTRA) testing in place? | No connectivity system available | Connectivity system is in place, but it only partially covers the network | Improvement project to select connectivity system supplier | |
| Data analysis | Are there adequately trained personnel, software and/or tool that receives laboratory data from all levels, analyses the data and generates reports? | There are trained personnel but not adequate software or tools to analyse and report Xpert MTB/RIF-(ULTRA) data | There are trained personnel, adequate software or tools to analyse data. Complete reports are generated on regular basis | Improvement project to implement ASAP-GxNet quarterly report data collection | |||
| Are statistical data collected, analysed and used for decision-making purposes and shared within NTP? | Only a few Xpert MTB/RIF-(ULTRA) indicators are collected and analysed | A comprehensive list of Xpert MTB/RIF-(ULTRA) indicators are collected and analysed and effectively used for decision-making purposes | Improvement project to implement quality indicators | ||||
| Reporting | Is there an electronic system that enables reporting of diagnostic data to local and national programme? | Electronic reporting for GeneXpert network improvement purposes is functional in reference laboratories only | Electronic reporting for GeneXpert network improvement purposes is functional at all levels and analysed for a limited range of purposes | Improvement project to implement ASAP-GxNet quarterly report data collection | |||
| 9/15 | 12/15 (80%) | Forecast | Is forecast of Xpert MTB/RIF-(ULTRA) needs done based on past and projected consumption? | No system and methodology are used | Past and projected consumption is used to forecast Xpert MTB/RIF-(ULTRA) needs. Forecasts are revised on a yearly basis | Training on cartridges forecast | |
| Service interruption | Have testing facilities provided uninterrupted GeneXpert testing services, with no disruption due to cartridge stockouts (or since last assessment)? | Some testing facilities (more than half of total number) have faced at least one instance in the last year of testing service interruption due to cartridge stockouts | Some testing facilities (less than half of total number) have faced at least one instance in the last year of testing service interruption due cartridge stockouts | Not dependent by ASAP-GxNet training | |||
| 2/6 | 4/6 (67%) | Network management | Does the national GeneXpert focal point have adequate managerial knowledge and skills (plan, organise, lead and control) to oversee the GeneXpert network? | The focal point has adequate knowledge of the network but limited capacity to plan and organise different tasks of the network | The focal point has adequate knowledge and skills to oversee the network | Training through the ASAP-GxNet programme | |
| Does the national GeneXpert focal point have a list of daily/monthly/annual routine work tasks? | No list of routine work tasks is available | A comprehensive list of daily/monthly/annual routine work tasks is available and performed in due time | Training through the ASAP-GxNet programme | ||||
| Does the GeneXpert focal point use and update the Xpert tracking or similar tool to optimise network management? | No | The Xpert tracking or similar tool is used, data exploited and regularly updated | Improvement project on implementation of Xpert tracking tool | ||||
| 2/6 | 2/6 (33%) | Quality assurance | Is a standardised checklist available and used to evaluate GeneXpert sites? | A standardised checklist is available and used but not complete | A standardised checklist is available and used to evaluate the site. In line with FIND checklist template | Improvement project to revise and update national document | |
| 2/12 | 7/12 (58%) | Diagnostic cascade quality indicator | End TB Strategy laboratory target indicator 1 | No data available | Data available target not achieved | Improvement project on implementation of Xpert tracking tool and data collection/analysis tool | |
| End TB Strategy laboratory target indicator 2 | Target achievable in a reasonable time frame | ||||||
| End TB Strategy laboratory target indicator 3 | |||||||
| End TB Strategy laboratory target indicator 4 | Data available, target not achieved | ||||||
| End TB Strategy laboratory target indicator 7 | Target achievable in a reasonable time frame | ||||||
| End TB Strategy laboratory target indicator 8 | Data available, target not achieved | ||||||
| Testing quality indicators | Data completeness | All data available, full analysis | |||||
| Error rate | Media rate below the target. One or more sites with rate above the target | ||||||
| Invalid rate | |||||||
| No result rate | Media rate below the target. No site with rate above the target | ||||||
| Specimens with a result reported within 24 h | Results reported in 24 h in some sites | ||||||
| Media of maximum Xpert testing capacity per month | Number of tests slightly below the maximum Xpert testing capacity (2–3 tests per day) | ||||||
| 31/45 | 41/45 (91%) | National policies and plan | Does the GeneXpert focal point revise the Xpert implementation plan every year? | Not done (due to reasons directly linked or not to GeneXpert focal point capacities) | Planned | Training through the ASAP-GxNet programme | |
| Algorithm | Does the GeneXpert focal point monitor, through data GeneXpert sites, the adherence of national diagnostic algorithm? | Yes, done and actions are taken for those sites not adherent | |||||
| Installation | Have you developed and/or updated a standardised training (1-day) materials? | Yes done | |||||
| Data management | Are information from GeneXpert sites routinely updated on Xpert tracking tool? | Yes done | |||||
| Are periodic data from GeneXpert sites routinely collected and analysed? | Yes done | ||||||
| Quality | Does the GeneXpert focal point periodically analyse quality indicators and results for all GeneXpert sites? | Yes done |
ASP-GxNet: Approach to Strengthen Performances of GeneXpert Networks; TB: tuberculosis; DST: drug-susceptibility testing; WHO: World Health Organization; FIND: The Foundation for Innovative New Diagnostics; SOPs: Standard Operating Procedures; NTP: national TB programme.