CLSI M50-A (R.2018) PDF

CLSI M50-A (R.2018) – Quality Control for Commercial Microbial Identification Systems; Approved Guideline, M50AE

Clinical and Laboratory Standards Institute document M50-A–Quality Control for Commercial Microbial IdentificationSystems; Approved Guideline includes a process for streamlined quality control (QC) of commercial microbial identificationsystems (MISs) that utilize multiple substrates and/or reagents to identify aerobic or anaerobic bacteria, yeasts, moulds, or yeastlikealgae from culture. It specifies responsibilities of the manufacturer, distributor, and user. M50-A includes guidelines thatmay be followed when using an MIS of proven reliability to take a modified QC approach, rather than meeting requirementsincluded in the Clinical Laboratory Improvement Amendments of 1988 regulations. The streamlined QC approach was developedfollowing an evaluation of data provided by the American Society for Microbiology for a survey conducted to determine the QCfailure rates of commercial MISs. The data showed a failure rate of less than 0.1% for all commercial MISs surveyed. Thisdocument is based on United States (US) regulations and will also serve as a useful resource for a wider audience. It isanticipated that M50-A will be used extensively in the United States and internationally to reduce resources spent on excessiveQC testing.