Individualized Quality Control Plans
How to Perform an IQCP in Compliance With CAP Requirements
Individualized Quality Control Plans (IQCPs) were introduced to give clinical laboratories more flexibility in how quality control is designed and maintained. Rather than relying solely on rigid, one-size-fits-all QC rules, IQCP allows laboratories to develop a quality plan that reflects how testing truly occurs in their specific environment. When done well, IQCP supports both regulatory compliance and patient safety. When done poorly, it is a common source of CAP inspection findings.
At RH Laboratory Consulting we frequently help laboratories strengthen or rebuild IQCPs that were cited during inspection—not because IQCP is flawed, but because it is often misunderstood or rushed. Understanding CAP’s expectations is essential for laboratories choosing this option.
IQCP applies only to nonwaived testing and remains optional under CLIA. Laboratories may continue to follow default QC requirements if they prefer. Before implementing an IQCP, it is critical to confirm that the test manufacturer allows its use and that the laboratory director has approved the decision. CAP places significant emphasis on documented director oversight throughout the IQCP process.
An IQCP is built on three required elements: a risk assessment, a quality control plan, and ongoing quality assessment. Each element must be thoughtfully developed, clearly documented, and actively maintained.
The risk assessment forms the foundation of the IQCP. CAP expects laboratories to take a realistic look at where failures could occur across the entire testing process, from specimen collection through result reporting. This includes evaluating risks related to specimens, the test system, reagents, the testing environment, and personnel. The intent is not to list hypothetical risks, but to identify where errors are most likely to occur in your laboratory and how those errors could impact patient care.
While tools such as FMEA or risk matrices are commonly used, CAP does not require a specific format. What inspectors look for is evidence that the assessment is test-specific and reflective of actual laboratory practices. Generic, templated risk assessments that do not clearly connect to the test system or workflow are among the most common deficiencies we see during inspections.
Once risks are identified, the laboratory develops the Quality Control Plan. The QCP explains how the laboratory will mitigate the risks outlined in the assessment. This includes defining QC frequency, calibration and maintenance activities, environmental monitoring, acceptability criteria, and required actions when QC fails. The plan must be practical and aligned with daily operations, as CAP inspectors will compare the written QCP directly to what is occurring at the bench.
Laboratory director approval of the QCP is required and should be clearly documented. Even a well-designed IQCP may be cited if approval cannot be demonstrated during inspection.
Quality Assessment completes the IQCP process and ensures the plan remains effective over time. CAP expects laboratories to monitor indicators such as QC failures, proficiency testing performance, instrument issues, and corrected reports. When trends or issues are identified, follow-up and corrective actions must be documented. Ongoing review shows that the laboratory is actively managing risk rather than treating IQCP as a one-time exercise.
IQCPs must be reviewed at least annually and whenever significant changes occur, including changes in instrumentation, reagents, test volume, environment, or staffing. In our consulting work, outdated IQCPs are one of the most frequent findings, particularly in laboratories that have experienced recent growth or system changes.
When implemented correctly, IQCP allows laboratories to move beyond basic compliance and adopt a more meaningful, risk-based approach to quality control. With intentional assessment, clear documentation, and ongoing oversight, IQCP can strengthen both inspection readiness and confidence in patient results.
If your laboratory is developing a new IQCP, revising an existing plan, or preparing for a CAP inspection, working with an experienced consultant can help ensure your IQCP is both compliant and practical for real-world operations.
