Indeed we believe that participation in external quality control or proficiency testing (PT) schemes is not enough to measure the performance of a laboratory.
CLIA regulations establish laboratory standards for quality assurance and quality control, personnel, proficiency testing, and maintenance of records.
Both bioanalytical laboratories participate in the WorldWide Antimalarial Resistance Network (WWARN) quality control and assurance proficiency testing program (http://www.wwarn.org/toolkit/qaqc).org/toolkit/qaqc
Stage 5 is where the assay enters routine use, and here, quality control (QC) monitoring, proficiency testing and batch-to-batch QC issues can be fully explored.
The laboratory participates in the WorldWide Antimalarial Resistance Network WWARNN) quality control and assurance proficiency testing program with satisfactory performance (http://www.wwarn.org/toolkit/qaqc) (31).
The laboratory participates in the WorldWide Antimalarial Resistance Network WWARNN) quality control and assurance proficiency testing program with satisfactory performance (http://www.wwarn.org/toolkit/qaqc).org/toolkit/qaqc
However, the 2007 European Quality Control for Molecular Diagnostics (QCMD) proficiency testing programme showed that CMV DNA detection in DBS was lacking sensitivity in a considerable number of participating laboratories.
In addition, laboratories were advised to maintain the quality control strain for future proficiency tests.
Upon approval of multigene biomarker tests for clinical applications, reference materials would play an integral part in ongoing quality control (QC) procedures and proficiency testing (PT) in clinical laboratories [ 10].
The lack of readily available, patient-derived materials for molecular genetic testing of many heterozygous or rare disorders creates a major impediment for laboratory proficiency and quality control procedures.
Individual laboratories are responsible for meeting the CLIA/CAP quality assurance standards with respect to appropriate sample documentation, assay validation, general proficiency, and quality control measures.
