Manufacturers must provide a Certificate of Analysis (CoA) to prove this testing occurred. 2. User (Laboratory) Responsibilities
Medical standards are routinely updated or superseded. Using an unauthorized copy risks using outdated protocols that could jeopardize laboratory accreditation (such as CAP or CLIA compliance). clsi m22a3 pdf link
Even when using 100% exempt commercially prepared media, clinical laboratories cannot completely bypass inspection. Under CLSI M22-A3 guidelines, every laboratory must perform the following actions upon receiving a shipment: Manufacturers must provide a Certificate of Analysis (CoA)
Even when relying on manufacturer certification, laboratories are not exempt from all oversight. Under M22-A3, laboratories must: clsi m22a3 pdf link