Module 8: Recording and reporting. Global Laboratory Initiative – Xpert MTB/RIF Training Package. Contents of this module. Record keeping Reporting of Xpert MTB/RIF results Entry of data into the Laboratory Register Consequences of inaccurate recording and reporting .
Module 8: Recording and reporting Global Laboratory Initiative – Xpert MTB/RIF Training Package
Contents of this module Record keeping Reporting of Xpert MTB/RIF results Entry of data into the Laboratory Register Consequences of inaccurate recording and reporting
Learning Objectives 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
To be customized according to country policy on retaining records Laboratory Record Keeping 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 by country. Add your local request form, and demonstrate to participants how to correctly complete the form. Laboratory Request Form: example Adapt according to NTP guidelines in your country
Laboratory Request Form: content Adapt according to NTP guidelines in your country 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
To be customized by country. Add your local report form, and demonstrate to participants how to correctly complete the form. Laboratory Report Form Adapt according to NTP guidelines in your country Report forms include microscopy and/or Xpert MTB/RIF results (and if applicable, culture and DST results)
Laboratory Register content Adapt according to NTP guidelines in your country 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
Laboratory Register (example) Adapt according to NTP guidelines in your country 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: * *
Accurate recording and reporting 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
Summary 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
Assessment 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?
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.