Individualized Quality Control Plan (IQCP)

Background

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 laboratories the opportunity to tailor an individualized quality control plan (IQCP) for their unique testing environment and patients. The IQCP option offers the laboratory flexibility for meeting regulatory QC requirements appropriate for the testing performed.

IQCP is an all-inclusive approach to assuring quality. It includes many practices that a laboratory already uses to ensure quality testing beyond requiring that a certain number of QC materials be tested at a designated frequency. IQCP applies to all nonwaived testing performed, including existing and new test systems. All CLIA specialties and subspecialties except Pathology are eligible for IQCP.

Educational Materials

CLIA Individualized Quality Control Plan Introduction

This brochure provides introductory information explaining the CLIA alternative QC option, IQCP.

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure11.pdf

CLIA IQCP, Considerations When Deciding to Develop an IQCP

This brochure provides information on what your laboratory needs to know before making the decision whether to develop and implement an IQCP. It describes scenarios and includes a flow-chart to assist in the decision-making process.

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure12.pdf

CLIA IQCP, What is an IQCP?

This brochure provides information on designing an IQCP. It explains the three parts of an IQCP, the five components of a risk assessment, considerations for creating a QC plan, and useful documents for identifying and selecting quality monitors for a quality assessment.

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure13.pdf

Developing an IQCP - A Step-By-Step Guide

This workbook is designed to assist in developing an IQCP for one or more test systems. Using an example scenario, the workbook guides 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.

IQCP Workbook LINK