What specific (e.g., CAP, CLIA) is auditing your laboratory?
Includes new recommendations for QC of media used to recover difficult-to-grow pathogens. Laboratory Inspection Requirements clsi m22a3 pdf
The standard established a practical cutoff for quality. It expanded the acceptable manufacturing failure rate from 0.3% to . This means that in the manufacturing process, a certain low level of failure was considered acceptable, which informed why some media were considered reliable enough for the "exempt" list. What specific (e
The laboratory must maintain documentation showing that the manufacturer is compliant with CLSI M22-A3 standards and has provided a Certificate of Quality Control for that specific lot. It expanded the acceptable manufacturing failure rate from 0
Provide a accessible for every batch. Laboratory End-User Obligations
Exempt media are highly stable formulations that historically show extremely low failure rates when prepared by reputable commercial manufacturers.