Update on quality management using EQA and RemoteXpert

Transcription

1 Update on quality management using EQA and RemoteXpert 1. Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Science, and NHLS, South Africa 2. Management Sciences for Health Wendy Stevens, Lesley Scott, National Priority Program, SA Alaine Umubyeyi Nyaruhirira, MSH SA

2 Quality Management for Xpert test Many quality system components have often been lacking in resourcepoor settings in general, and the quality assessment programs for the Xpert MTB/RIF assay have been no exception. There are three components that appear critical for ensuring the quality and accuracy of Xpert MTB/RIF testing: (i) verification of each GeneXpert module (on installation or repair) to ensure that the instrument is fit for purpose before testing and reporting on clinical specimens, (ii) external quality assessment to ensure that the entire testing process (pre analytical, analytical, and post analytical) is managed for quality results, and (iii) continuous performance monitoring (positivity rate, error rate, usage, etc.)

3 Country Experience : Initiating an external quality assurance programme for Xpert MTB/RIF instrument in Ghana (Pilot Phase) Although internationally-approved external quality assurance (EQA) programs have been well-defined for TB laboratory tests such as microscopy, culture, and susceptibility testing, large scale EQA for Xpert MTB/RIF testing has not yet been assessed or endorsed. Consequently, most countries have not initiated EQA for Xpert MTB/RIF. In response to this gap, the Ghana National TB Program (NTP), with support from USAID s TB CARE I project, developed an EQA process for Xpert MTB/RIF using dried culture spots (DCSs) in conjunction with the National Health Laboratory Service (NHLS) (see Figure2).

4 Materials and Methods The use of DCSs allows samples to be shipped without biohazard concerns and at a cost that is less than one tenth the cost of other EQA transportation methods. Sent four DCS panels to each of the hospitals laboratories: MTB-positive Rifampicin-sensitive strain; MTB-positive Rifampicin-insensitive strain; Non-TB mycobacteria; and A negative control. Sent the DCS panels results to the National Health Laboratory Service (NHLS) in South Africa for EQA analysis and validation; The scoring according to the following system: Pass = %, Acceptable = 85-90%, Concern = 70-85%, Unacceptable = 50-69% ; Fail = < 50%; No submission

5 Current TB GeneXpert Quality program using Dried Culture Spots, Verification (Gx installation, maintenance, calibration/module) 2. EQA (3 panels/year, per Gx computer) 1. DCS panel 2. Information 3. SOP 4. Barcodes Inactivated dried TB culture spots tested on a GeneXpert instrument for verification and EQA. Figure 2. Summary of the DCS Submission and reporting Automated result reporting

6 The NTP and TB CARE I piloted this EQA process at four hospitals in Ghana from October 2013 to April To do so, they followed these steps: Intervention Conducted a one-day training on EQA using the DCSs for all laboratory staff at each hospital Helped the hospitals register with an Xpert MTB/RIF online reporting system called Tb GX Monitor (see Figure 2) Uploaded the Xpert MTB/RIF results onto the TB GX Monitor; Facilitate the transport of DCS panels in Accra during the validation phase Training on DCS use for EQA at the Atua Hospital in Ghana

7 Third quarter EQA scores on the DCS panels determined by the four hospital laboratories using Xpert MTB/RIF Results: For three quarters, the NTP and TB CARE I helped the hospitals submit three panels with 32 DCS to NHLS Each quarter, the hospital panels received EQA scores of 100percent showing a high level od staff proficiency in Xpert MTB /RIF testing process

8 Update on quality management of Xpert technology Verification: By the end of 2014, 4,317 verification DCS were performed globally with 97.4% of the modules functioning correctly. Spots now being distributed with new instruments via Cepheid. EQA uptake: Increased from 17 participants (2012) to 295 (2014) i.e. currently 392 devices in 18 countries. Timely submission of EQA panel results fluctuated from %, with incorrect results accounting for 1.2% and 0.6% for device error (including invalid tests), showing overall stable performance of Xpert MTB/Rif.

9 GeneXpert Dashboard (Remote Xpert): National Health Laboratory Service performed beta trial, results under analysis A Web portal that is a device relationship management platform Courtesy Prof Wendy Stevens, NHLS NPP and Cepheid

10 NPP NHLS experience Beta 1 (2014): 6 NHLS sites. Feedback: IT support required for each site installation Training required for functionality and navigation Real time monitoring adds value to program monitoring and identify audit indicators and improvements on work flow. Beta 2 (2015): 17 sites, 25 systems (Gx4 Gx80) Feedback: majority sites performed installation remotely through Xpert reporter (issue with 2 systems/network web connection), user guide great and Cepheid support always available Managed ~ results aligned with NHLS LIS data and improved error reporting (not recorded by LIS which is patient result driven). RemoteXpert instrument performance driven: Improved reporting of errors (temperature concerns, power failures, training alerts, stock management, PC failure/downtime) Web features improved: filtering, trend lines, navigation easier, download direct, set thresholds, administrator can access gxx/user CSV, Some parameters removed: user names, run report times, Ct (available through LIS GIS/Epi spatial transmission hot spots and mycobacterial burden).

11 Conclusions& Recommendations on DCS and Remote Xpert Conclusion: o The NHLS DCS test proved to be an appropriate vehicle for pilot testing the use of EQA for Xpert technology. o Ghana pilot project provide a field-tested model for national scale-up and the NTP endorses the program and expand the process to all new sites through the National TB strategic plan ( ) supported by Global fund. o Verification and 3x/year EQA is not sufficient for overall quality management, and NHLS have been working with Cepheid to evaluate and improve the Remote Xpert. This is a dashboard that collects all data in real time for lab managers to evaluate their instruments performance: - positivity and Rif rates, - error rates, - instrument utility etc. But, it does not retain patient identification information.

12 Recommendations: o The DCS program should be evaluated in a large scale as the uptake shown us a large number of countries involves o The results eventually be used to feed into the global policy guidelines on EQA for Xpert and it endorsement and scale up will reduce the cost. o Verification panel and 3x/year EQA is not sufficient for overall quality management, and NHLS have been working with Cepheid to evaluate and improve the Remote Xpert. o Implementation of Xpert and its massive roll out require quality assessment program. Monitoring of GeneXpert instrument, cartridge performance should be complemented with monitoring of the complete testing process.

13 Acknowledgment TB Care I Team in Ghana Ghana NTP NPP team (NHLS) CDC South Africa Wits University (Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Science )