1. Governance | 9/15 (60%) | 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 (e.g. those at risk of multidrug-resistant TB, HIV/TB or paediatric TB) | The national algorithm incorporates universal access to WRDs for all patients and all persons being evaluated for TB | Improvements not dependent by ASAP-GxNet Following network analysis country planned to move to universal use of Xpert MTB/RIF in 2020 |
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 Country planned to move to integrated specimen referral system |
2. Coverage | 5/9 (56%) | 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 Revised every year (or when needed) | Improvement projects on “development of a document for identification of network needs” Training on the use of “ASAP-GxNet assumption tool” |
3. Installation roadmap | 4/9 (44%) | 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 training on the use of ASAP-GxNet matrix needs tool |
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 |
3. Installation roadmap, continued | 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 |
4. Maintenance | 6/9 (67%) | 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 Training on calibration plan and strategy |
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 ad hoc back-up plan takes place during equipment failure | 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 |
5. Data management | 4/9 (44%) | 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 Connectivity system implementation on-going |
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 Training through the ASAP-GxNet programme |
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 Training 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 |
6. Supply chain management | 9/15 (60%) | 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 Improvement projects to develop a back-up plan for GeneXpert machine troubleshooting |
7. Workforce | 2/6 (33%) | 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 |
8. Quality | 2/6 (33%) | 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 |
9. Quality indicators | 2/12 (17%) | 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 |
9. Quality indicators, continued | 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) |
10. Network Management | 31/45 (69%) | 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 |