Developing an IQCP : a step-by-step guide
Corporate Authors:Centers for Disease Control and Prevention (U.S.). Center for Surveillance, Epidemiology, and Laboratory Services. Division of Laboratory Systems. ; Centers for Medicare & Medicaid Services (U.S.) ;
Description:The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a laboratory to have quality control (QC) procedures to monitor the accuracy and precision of the complete testing process. A QC option is now available that provides you the opportunity to tailor an individualized quality control plan (IQCP) for your unique testing environment and your patients. The IQCP option offers your laboratory flexibility for meeting regulatory QC requirements appropriate for the testing you perform and when you add a new test.
IQCP is an all-inclusive approach to assuring quality. It includes many practices that your laboratory already uses to ensure quality testing beyond requiring that a certain number of QC materials be tested at a designated frequency. IQCP can be applied to all nonwaived testing performed, including existing and new test systems. All CLIA specialties and subspecialites except Pathology are eligible for IQCP.
This workbook is designed to assist in developing an IQCP for one or more test systems. Using an example scenario, the workbook will guide you through a step-by-step process to develop an IQCP that can be sustained and modified, as needed, over time. You will evaluate your current quality activities and develop an IQCP worksheet which, when completed, can serve as your IQCP document. The approach outlined in this workbook is not mandatory or the only format for documentation, but is one example that can be used. You are free to develop your own format that meets the needs of your laboratory.
At the completion of this workbook you will have performed a Risk Assessment, created a Quality Control Plan, and conducted a Quality Assessment for the test system being evaluated for an IQCP.
At head of title: IQCP: Individualized Quality Control Plan.
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