Clsi: M22a3 Pdf Link

Aligns laboratory practices with major accreditation bodies like the College of American Pathologists (CAP) and the Joint Commission.

Nevertheless, many laboratories may choose to follow CLIA quality assurance regulations directly. For laboratories that elect to use an IQCP for media listed as exempt in M22-A3, the CAP explicitly allows laboratories to "accept quality control performed by the media manufacturer in lieu of performing its own end user quality control".

Having the official PDF document allows laboratory directors and managers to: Properly categorize new inventory as exempt or non-exempt. clsi m22a3 pdf link

, the Centers for Medicare & Medicaid Services (CMS) changed the regulatory landscape for media quality control in the United States. CMS no longer recognizes the "exempt" and "nonexempt" categories established in M22-A3 for the purposes of quality control. Instead, clinical laboratories subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) must either:

The guidelines simplified the basic protocols for maintaining QC organisms. Having the official PDF document allows laboratory directors

Even when relying on manufacturer certification, laboratories are not exempt from all oversight. Under M22-A3, laboratories must:

These media require routine quality control testing by the user laboratory. major medical center

Audit manufacturer quality certificates against CLSI requirements.

If your laboratory is affiliated with a university, major medical center, or research hospital, check with your institutional medical library. Many academic libraries maintain active subscriptions to CLSI databases, allowing personnel to download the official PDF for internal use at no additional cost. Conclusion

Implementing the M22A3 standard provides a multitude of benefits for clinical microbiology laboratories:

Quality Control for Commercially Prepared Microbiological Culture Media Whether you are looking for the official CLSI M22-A3 PDF