Step 8.1 – Review and revise request for examination and reporting forms
Step 8.2 – Review and revise laboratory and clinical registers
Step 8.1 – Review and revise request for examination and reporting forms
It may be necessary to revise the country’s current test requisition form (i.e. specimen examination request form) to accommodate a new diagnostic test. Countries should determine whether an update of the examination forms is needed, considering the cost and time required for such a revision. If a system is not already in place, countries should establish a numbering system to identify repeat samples from the same person, to monitor the proportion and performance of repeat tests.
Given that patient data (e.g. treatment status) are critical for the correct interpretation of test results, programmes should ensure that the test request form captures such information. In many countries, request forms already contain fields for such data; however, sometimes data may either not be entered in some of these fields or entered inconsistently. Refresher training for clinical and laboratory staff should be conducted, to ensure that forms are filled out correctly and completed properly.
The forms used for reporting test results must balance the need to convey the test information while also conveying the information that is essential to allow a clinician to interpret the results and act promptly on them. An easy-to-read format is important because there is likely to be a wide range of expertise among the clinicians interpreting test results. Also, to avoid confusion, results should only be reported for medicines that are being used in-country and align with national guidelines. For example, WHO recommends against the use of AMK, except for people with XDR-TB; hence, AMK results should only be reported when relevant for clinical decisions.
An easy-to-read format is particularly important for targeted NGS tests because these tests generate a large amount of data. At a minimum, the reporting form should capture the unique patient identifier; also, for each drug analysed, the report form and database should include information on the genes analysed, any mutations detected, and the corresponding confidence grading and resistance profile for each drug. It is recommended that quality criteria (e.g. at least 10 successful reads per base across the gene of interest) be met for results to be reported.
A global consortium previously led a consensus process to standardize language for reporting of NGS-based DST results and generate a generic reporting form for MTBC NGS-based DST results (40). The consensus forms are intended to be used to report NGS-based DST results to clinicians for use in patient-care decisions, but may also be useful guides for developing forms for reporting information for a DR-TB surveillance system.
Step 8.2 – Review and revise laboratory and clinical registers
Current laboratory and clinical registers that are based on the WHO reporting framework (15) may need to be modified to record the results of the diagnostic test being implemented. Forms for laboratory records may also need to be modified. Countries should implement a standardized approach for recording test results in laboratory and clinical registers, and should use that approach consistently across all testing and clinical sites. Countries with electronic laboratory information management systems may need to include news tests in the software package.