Xpert MTB/RIF test. Laboratory monitoring & evaluation tool Xpert Pre-handover Checklist
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1 Xpert Pre-handover Checklist Part 1: Contact details Date of installation Facility name/ Laboratory name Contact details facility: Name, phone, GeneXpert laboratory responsible Contact details Laboratory: Name, phone, Partner organisation Contact details partner Organisation Name, phone, Part 2: Equipment details GeneXpert serial number(s) Number of modules Laptop/Desktop Brand of computer Windows version GeneXpert Software version UPS details Antivirus version Printer details Battery/stabiliser details Page 1 of 5
2 Part 3: Site plan Support by partners ending on date Hospital or NTLP to take over (please mark as appropriate) Cartridge supply (Average no. per month) Calibration Technical support: Statistical support Computer support Printer/Ink/Paper Other: Any other outstanding issues? At handover date estimate remaining cartridges and expiry Have all GeneXpert passed calibration in the last month? Attach report; If no explain, and detail what follow up action is being undertaken Has error rate over last 3 months been below 5% Has total unsuccessful test rate been below 10%? Has Cepheid examined last 3 month system log and.gxx files? To the best of your knowledge and using all available tools is the GeneXpert machine in full working order as of hand over date? Is this machine still under original warranty Has any extended warranty been purchased Date of warranty end Date of warranty end Page 2 of 5
3 Was this site previously following NTLP testing algorithm? If no which algorithm was used Was this site previously supplying monthly indicators to the NTLP? If no, what was agreement and can staff produce monthly statistics? Are there any additional training needs to ensure a smooth handover? Have all staff performing testing completed and passed a certified training program for Xpert MTB/RIF testing Have clinical staff completed sensitisation about MTB/RIF testing Are standard NTLP procedures, SOPs, registers and other documents in pace Additional comments: Detail: If no detail: If no detail: If no detail: Page 3 of 5
4 Part 4: Other documents to be supplied at handover Certification document Supplied with machine Verification documents *to be decided how many and what is required System log and last 3 months.gxx files New IQ reports Copy of last 6 months maintenance records Copy of staff training certificates for Xpert MTB/RIF Evidence of clinical sensitisation Provide a letter explaining handover to be sent to Cepheid as evidence of change of owner As per document, how to generate a system log report and How to archive and delete runs As per document how to generate an IQ report Copied from laboratory records, if any missing please explain below Copied from laboratory records, if any missing please explain below Certificates, training schedule, meeting minutes As per document Page 4 of 5
5 Part 5: Completion of GeneXpert Handover Partner signs to declare handover of GeneXpert instrument in full working condition and has no further role apart from that documented above NTP CTRL signs to confirm receipt of GeneXpert machine in full working condition and takes responsibility for full site support, including reagent supply, calibration and technical support Comments Disputes: Further actions: Final handover date: Page 5 of 5
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