CLSI M50-P

Clinical and Laboratory Standards Institute document M50-P-Quality Control for Commercial Microbial IdentificationSystems; Proposed 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-P includes guidelines that maybe followed when using an MIS of proven reliability to take a modified QC approach, rather than meeting requirements includedin 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. While thisdocument will serve as a useful resource for a wider audience, it is based on US regulations. It is anticipated that M50-P will beused extensively in the United States and internationally to reduce resources spent on excessive QC testing.

Published:

12/01/2007

ISBN(s):

1562386557

Number of Pages:

36