What is the minimum frequency for performing assay controls consistent with CLIA regulations?
However, for certain tests, i.e., blood gases, hematology and coagulation tests, etc., CLIA requires additional QC: Blood gases require, at a minimum, one control sample every 8 hours of testing and a calibrator or control in each run unless the instrument “autocals” at least every 30 minutes.
How do you use IQCP?
WHAT ARE THE 3 STEPS OF THE IQCP? The IQCP process includes: Risk Assessment, Quality Control Plan (QCP), and Quality Assessment (QA). An IQCP must address the potential failures and errors identified in the entire testing process: preanalytic, analytic and postanalytic phases of testing. WHAT ARE WE ALREADY DOING?
What is a QC test?
Quality control involves testing units and determining if they are within the specifications for the final product. The purpose of the testing is to determine any needs for corrective actions in the manufacturing process. Good quality control helps companies meet consumer demands for better products.
How often should QC be done?
It is widely accepted that laboratories should perform QC at least every day of patient testing.
What is waived testing in a lab?
Waived testing is laboratory testing that employs specific test methods designated under the Clinical Laboratory Improvement Amendments (CLIA) of the Food and Drug Administration (FDA) as “waived.” Waived testing is designated by CLIA as simple tests that carry a low risk for an incorrect result.
What is iqcp and how does it work?
IQCP permits the laboratory to customize its QC plan according to test method and use, environment, and personnel competency while providing for equivalent quality testing.
Do I need an iqcp for my reagents or tests?
For some microbiology reagents or tests, quality control requirements have not changed and the use of an IQCP is not needed because the QC required is already compliant with regulatory requirements. Refer to the checklist requirements listed for the complete requirements.
Where can I find the iqcp procedure?
The IQCP procedure is located in the guidance for §493.1256 (d) found in the State Operations Manual, Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (PDF). Refer to the downloads and the related links sections below for the State Operations Manual and additional educational information.
What are some individualized quality control plan iqcp examples?
Individualized Quality Control Plan IQCP Examples Individualized Quality Control Plan IQCP Examples Susan E. Sharp, Ph.D., ABMM, FAAM Director, Airport Way Regional Laboratory Director, Regional Microbiology and Molecular Infectious Diseases Laboratories Kaiser Permanente Department of Pathology