Roadmap to GeneXpert implementation

GeneXpert implementation roadmap

Policy & planning phase

Country consultation

• MOH appoints NTP/NTRL focal person for Xpert MTB/RIF implementation

and technical partner consultant engaged, if needed

• Technical Working Group convened and chaired by MOH to lead

guidelines/strategic plan development and implementation process

• Review Country Lab Strategic Plan and TB diagnostic guidelines and

strategic plan

• Prepare or revise Xpert MTB/RIF implementation plan (3-5 year and annual

plan)

• Site selection and phased implementation plan

Pre-installation phase

Pre-installation checklist

Installation & training phase (1)

Training

(User & Clinical)

Training:

• Conduct Xpert MTB/RIF training of trainers

• Conduct Xpert MTB/RIF User (laboratory) training

• Conduct Xpert MTB/RIF Clinician training

• Conduct Xpert MTB/RIF advanced user/supervisor

training

Competency

assessments

Installation

Installation checklist

Installation & training phase (2)

Package I (provided)

• GeneXpert country specific installation checklist

• GeneXpert installation accompanying documents

• GeneXpert Manual

• Xpert MTB/RIF SOP

• Xpert MSDS

• Xpert maintenance SOP

• Xpert maintenance records

• Xpert sputum sample collection SOP

• Xpert MTB/RIF WHO reporting codes

• Xpert patient ID recording codes

• Xpert error records and Corrective Action Log

• Xpert monthly indicator reporting form

• Xpert Calibration Log

• Xpert error code list

• Xpert User training package

• Xpert Clinical training package

• Sputum rejection criteria

• PPE donning instructions

Package II (In-country tools)

• TB suspect screening tool

• Sputum testing national testing algorithm

• Sputum sample testing request form for Xpert

• Laboratory sample register

• Results reporting procedures

• Sample TAT records

• Patient tracing procedure

• Patient initiation onto treatment procedures

• RIF detected reporting to NTLP procedures

• Stock ordering protocols

• Stock cards

• Incidence occurrence records

• Waste management procedure

• Sample collection for culture

• Sputum transport procedure

• Spill management procedure

• Temperature monitoring records

Installation

Early implementation phase (1)

Competency

assessments

• Conduct regular on-site supervision visits according to agreed schedule using standardized checklists

• Mentor supervisors/advanced users in troubleshooting, on-site supervision and training

• Establish monthly reporting and review of laboratory quality indicators

• Enroll Xpert sites in EQA programme

• Establish regular maintenance, calibration and servicing of instruments

• Establish supplies management system

• Early implementation programme evaluation

• Handover of partner-supported sites to MOH for routine implementation

Training

(Focal point & RTLC)

Checklists Program evaluation Handover

Early implementation phase (2)

Quarterly

checklist

Supervision

checklist

Comprehensive

checklist

Pre-handover

checklist

Routine testing phase (1)

• Conduct regular on-site supervision visits according to agreed schedule using standardized

checklists

• Conduct routine monthly reporting and review of laboratory quality indicators

• Xpert sites participate in EQA programme

• Conduct regular maintenance, calibration and servicing of instruments

• Routine programme monitoring and evaluation

• Follow-up training and re-training as required

Training

(User, clinical, Focal point

& RTLC)

Checklists Competency

assessments

Routine testing phase (2)

Comprehensive checklist Supervision checklist Quarterly checklist

This presentation was developed by FIND. The work was supported by

Cooperative Agreement Number 3U2GPS002746 from the Centers for

Disease Control and Prevention (CDC). Its contents are solely the

responsibility of FIND, and do not necessarily represent the official views of

the CDC.

Acknowledgements