One of the targets of this phase is to write SOPs for all the tests performed in the laboratory. Therefore, you first have to identify all tests so you get to know which SOPs need to be written.
Activities related to Phase 1 - Documents and Records
All the test procedures should be documented. As already explained in the Equipment QSE, it is most efficient to already follow the SOP outline and put everything in an SOP format, even though the document control system has not yet been established (and version numbers etc. are not yet used). Follow the outline provided in the infosheet for all analysis SOPs.
The TB CAP Laboratory Toolbox provides several generic analysis SOPs. These SOPs were written for the most common tests performed in TB laboratories. IMPORTANT: when these SOPs are adapted to the local situation, be sure to follow the outline given in the Infosheet analysis SOP, so that the outline of all analysis SOPs within the laboratory is equal. Include for every test the critical/alert intervals for the test results. Also include a Tasks and responsibilities matrix, something not present in the TB CAP Laboratory Toolbox templates.
The TB CAP Laboratory Toolbox provides generic SOPs for the following tests:
- Ziehl-Neelsen staining
- Auramine staining
- Specimen processing for culture
- Drug susceptibility testing, proportion method
- Identification of Mycobacterium tuberculosis
- Niacin test
- Catalase test
- Nitrate reduction test
- Growth on PNB medium
Make sure that these SOPs are read by all relevant personnel members.
Another important element that should be included in each SOP are workforms for every test or procedure: these are forms that are used while carrying out a certain test. On these forms all the important data are captured such as lot numbers of reagents used, the amounts of reagents used, sample IDs, calculations, results, etc. These forms serve as interim reports and from these the final reports will be filled out. The African Centre for Integrated Laboratory Testing (ACILT) has generously provided several of these forms as example.
These forms are mainly meant to be able to check correct performance. They serve as a guide to the technician to keep track of his/her work. Besides: if erroneous results are detected one can look back in these forms where the analysis went wrong and what may have been the cause.