2. Module 8: Recording and reporting Global Laboratory Initiative – Xpert MTB/RIF Training Package

3. Global Laboratory Initiative Xpert MTB/RIF Training Package -2--2-  Record keeping  Reporting of Xpert MTB/RIF results  Entry of data into the Laboratory Register  Consequences of inaccurate recording and reporting

4. Global Laboratory Initiative Xpert MTB/RIF Training Package -3--3- At the end of this module, you will be able to:  Describe essential elements of recording and reporting Xpert MTB/RIF results  Report Xpert MTB/RIF results on the Laboratory Request Form  Record Xpert MTB/RIF results correctly in the Laboratory Register

5. Global Laboratory Initiative Xpert MTB/RIF Training Package -4--4-  Laboratory Request Form (Request for examination of biological specimen for TB)  Laboratory Report Forms  Laboratory Registers (may vary depending on diagnostics available in laboratory) Retain all laboratory records according to National policy To be customized according to country policy on retaining records

6. Global Laboratory Initiative Xpert MTB/RIF Training Package -5--5- To be customized by country. Add your local request form, and demonstrate to participants how to correctly complete the form. Adapt according to NTP guidelines in your country

7. Global Laboratory Initiative Xpert MTB/RIF Training Package -6--6-  Name of treatment unit  Date of request  Patient's information ( i.e., name, sex, age, address, and patient/suspect register number)  Number of specimens and specimen type sent for testing  Date of collection of specimen(s)  Reason for examination (e.g., diagnosis or follow-up)  Signature of person requesting examination Adapt according to NTP guidelines in your country

8. Global Laboratory Initiative Xpert MTB/RIF Training Package -7--7-  Report forms include microscopy and/or Xpert MTB/RIF results (and if applicable, culture and DST results) To be customized by country. Add your local report form, and demonstrate to participants how to correctly complete the form. Adapt according to NTP guidelines in your country

9. Global Laboratory Initiative Xpert MTB/RIF Training Package -8--8-  Date specimen received and collected  Laboratory Serial Number  Type of specimen  Patient's information (i.e., name, sex, age, address and register number)  Reason for examination (e.g., diagnosis or follow-up)  Microscopy results (and results of culture and/or DST, if applicable)  Xpert MTB/RIF results ◦ Add a new column, or record in the column “Comments” ◦ Similar to microscopy, use red or other colored pen for positive and resistant results  Name and signature of person performing test Adapt according to NTP guidelines in your country

10. Global Laboratory Initiative Xpert MTB/RIF Training Package -9--9-  As a temporary measure, NTPs may use the existing laboratory register by recording Xpert MTB/RIF results in the “comments” column  The format of the laboratory register should be modified to include a specific column for Xpert MTB/RIF results  Example: * * Adapt according to NTP guidelines in your country

11. Global Laboratory Initiative Xpert MTB/RIF Training Package -10- Accurate recording and reporting of results is absolutely critical: False-negatives mean that the results that were reported as negative were truly positive  Patients with TB may not be treated resulting in on-going disease, disease transmission, or death. False-positives mean that the results that were reported as positive were truly negative  Patients are treated unnecessarily or treatment may continue longer than necessary  Medications will be wasted  Patient has a different underlying condition that requires treatment

12. Global Laboratory Initiative Xpert MTB/RIF Training Package -11-  Main laboratory record keeping consists of: Laboratory Request Form, Laboratory Report Form, Laboratory Register  WHO provides a standardised reporting framework for TB, which should be customized by the countries  Accurate recording and reporting is absolutely critical to avoid inaccurate/false results

13. Global Laboratory Initiative Xpert MTB/RIF Training Package -12-  What are the key elements required for accurate record keeping?  What essential data must be entered into the Laboratory Register?  What is a false-negative result and false-positive result?  What are the consequences of a false-positive result being reported?

14. Acknowledgements The Xpert MTB/RIF Training Package has been developed by a consortium of GLI partners, including FIND, KNCV, US CDC, USAID, TB CARE I and WHO, with funding from USAID. The modules are based on materials originally developed by FIND, KNCV and Cepheid.