Clinical and Laboratory Standards Institute document M50-P-Quality Control for Commercial Microbial Identification
Systems; Proposed Guideline includes a process for streamlined quality control (QC) of commercial microbial identification
systems (MISs) that utilize multiple substrates and/or reagents to identify aerobic or anaerobic bacteria, yeasts, moulds, or yeastlike
algae from culture. It specifies responsibilities of the manufacturer, distributor, and user. M50-P includes guidelines that may
be followed when using an MIS of proven reliability to take a modified QC approach, rather than meeting requirements included
in the Clinical Laboratory Improvement Amendments of 1988 regulations. The streamlined QC approach was developed
following an evaluation of data provided by the American Society for Microbiology for a survey conducted to determine the QC
failure rates of commercial MISs. The data showed a failure rate of less than 0.1% for all commercial MISs surveyed. While this
document will serve as a useful resource for a wider audience, it is based on US regulations. It is anticipated that M50-P will be
used extensively in the United States and internationally to reduce resources spent on excessive QC testing.
| ISBN(s) : | 1562386557 |
| Number of Pages : | 36 |
| Published : | 12/01/2007 |
