CLSI M67—Verification of Laboratory Automation in Microbiology describes recommendations for verification and implementation of various modules associated with microbiology laboratory automation (MLA) systems in medical microbiology laboratories. Guidance is provided on modules for specimen processing, plate transport and incubation, and plate imaging, as well as software components associated with digital plate reading and image analysis, along with issues to consider when implementing MLA in stages or all at once. Guidance is also provided on postverification quality assurance for MLA, including facilities and safety management, management of downtimes, verification after changes, proficiency testing and alternative assessments, and personnel management.

CLSI M67 provides recommendations and best practices for the verification and implementation of microbiology laboratory automation (MLA) in medical microbiology laboratories. MLA as described in CLSI M67 includes the various modules associated with MLA systems that can be fully integrated or independently used, including specimen processing modules (SPM), plate transport and incubation modules (PTIM), and plate imaging modules (PIM). Additionally, software components associated with digital plate reading (DPR) and image analysis algorithms (IAA) are included. Guidance is provided on issues to consider when implementing MLA, including the decision to implement in stages or all at once, the number and type of specimens to select for verification, the incorporation of partial or full MLA into existing processes in the laboratory, and recommendations for QC of MLA and postexamination management.
 

The target audiences for CLSI M67 are medical microbiologists directing, managing, supervising, and/or performing cultures for the recovery and identification of pathogens from clinical specimens submitted for diagnosis at medical laboratories (eg, hospital laboratories, reference laboratories). CLSI M67 provides recommendations for:
• Elements to consider for implementation
• Selection of samples to process with MLA, including Gram stain smear preparation
• Verification testing, including suggested number of samples, medium types, reference methods, discrepant results analysis, and acceptance criteria
• Verification of automated interpretation software
• Verification of results transmission from the MLA to the LIS
• Postverification QA, including managing instrument downtimes

CLSI M67 does not provide recommendations for:
• Verification of automation in the medical microbiology laboratory other than sample processing, incubation, and imaging
• MLA selection and preparation of colonies for downstream applications (out of scope)
• General verification of organism identification and antimicrobial susceptibility testing (AST) (refer to CLSI M521)
• Development of artificial intelligence algorithms or applications