What Is an IQCP?

The IQCP (Individualized Quality Control Plan) for a clinical laboratory is a tailored approach to quality control (QC) that ensures accurate and reliable test results in diagnostic testing. It is a framework required by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). The IQCP allows laboratories to customize their quality control practices, considering their specific testing procedures, equipment, environment, and risks (1). This means that instead of relying on standardized QC procedures that might not be ideal for every setting, laboratories can design a quality control system that fits their unique circumstances and needs. It is intended to address the specific challenges each laboratory faces in maintaining the integrity of test results.

How Would I Benefit from Having an IQCP?

A point-of-care (POC) laboratory customer, such as a doctor’s office or clinic using portable testing devices, would benefit from an IQCP ensuring that their testing processes are accurate, reliable, and compliant with regulatory standards. POC testing often occurs outside the central laboratory, sometimes in non-traditional environments like a patient’s bedside or remote settings. This can introduce additional variables, such as operator skill, environmental factors, or equipment conditions that may affect test results (2). An IQCP enables POC laboratories to establish and monitor their quality control measures based on these factors, ensuring that the diagnostic results produced are valid and reproducible, even in such challenging environments.

In addition to ensuring accuracy, an IQCP helps point-of-care (POC) laboratories meet regulatory compliance requirements. By implementing an IQCP, a laboratory can demonstrate its commitment to quality assurance and reduce the risk of errors in diagnostic testing. This is essential for maintaining patient safety, meeting accreditation standards, and avoiding costly fines or penalties (3). For point-of-care laboratories, where rapid and accurate results are critical, an IQCP ensures that the tests performed meet the necessary clinical and regulatory expectations while addressing the specific constraints and challenges of the point-of-care setting.

How Do I Get Started Building My IQCP?

For customers that are new to in-house testing or who have not previously had an IQCP in place resources are available to help build a good IQCP. The Center for Disease Control published an IQCP Workbook, which is a step-by-step guide for building your IQCP. There are also resources on the Individualized Quality Control Plan page of the CMS website. If you are working with a manufacturer or distribution rep to bring new testing solutions into your clinical practice, they may also have resources to support you when building your IQCP.

If you would like to speak with a SEKISUI Diagnostics rep to learn about our testing solutions contact us here.

References

1. Centers for Medicare and Medicaid. Centers for Medicare and Medicaid - Individualized Quality Control Plan (IQCP). Centers for Medicare and Medicaid. [Online] https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/quality-control.
2. Center for Disease Control. CLIA Individualized Quality Control Plan Considerations When Deciding To Develop An IQCP. Center for Disease Control. [Online] 2014. https://www.cdc.gov/lab-quality/docs/IQCP-considerations-developing.pdf.
3. —. Individualized Quality Control Plan. Center for Disease Control. [Online] 2024. https://www.cdc.gov/lab-quality/php/iqcp/index.html.