QMS Tools and Resources | CDC

Public health and clinical laboratories require a foundation of quality to ensure fidelity in the total testing process. Laboratory operations need to be reliable, tests need to be as accurate as possible, and test results must be promptly delivered. Failures at any step within these systems could result in consequences for patient and population health.

Quality Management Systems (QMS) have been described by the International Organization for Standardization (ISO) and the Clinical Laboratory Standards Institute (CLSI) as “coordinated activities to direct and control an organization with regard to quality.” A QMS investigates the entire laboratory system, and many accreditation programs now require clinical laboratories to develop and follow QMS for their NGS-based tests.

Use of trade names is for identification only and does not imply endorsement by the US Department of Health and Human Services.

CDC and APHL adopted the CLSI 12 QSEs as building blocks for developing a QMS for clinical and public health laboratories performing NGS-based tests.