The IQCP (or Individualized Quality Control Plan) suffers from the appearance of being a string of extremely boring words constructed by a committee of extremely boring people. This hides the fact that it is important for all clinical laboratories. Use it to your advantage.
Why Do I Need an IQCP?
The understand the reason behind IQCP (Individualized Quality Control Plan) we need to look at what Quality Control looks like without it.
It is required that every non-CLIA-waived test must be QCed at least once per day in which that test is run. So let’s say you have a MRSA PCR test on the BD benchtop system. You would need to run QC every single day that a test is run. As one might expect, this would be a large drain on resources for a lab, especially a small one. It would require reagent, quality control materials, and personnel hours to do this. Every. Single. Day.
One way around this massive waste of resources is to set up an Individualized Quality Control Plan (IQCP). The IQCP is a way to gauge the risk of spacing out your QC to a more reasonable period of time. For instance, in our MRSA PCR example above, you may want to run it once per month instead of every day. So, you would need to design an IQCP for that.
Keep in mind, this may not be possible or recommended for some analytes such as those on a chemistry analyzer that can be quite unstable. And most hematology and coagulation systems should be QCed every 8 hours.
The Individualized Quality Control Plan (IQCP) is a flexible approach to quality control (QC) in clinical laboratories, introduced by the Centers for Medicare & Medicaid Services (CMS) to ensure accurate and reliable test results. IQCP is particularly useful for tests where traditional QC methods may not be feasible or where a more tailored approach to quality management is needed.
What Are the Parts of an IQCP?
The three main elements of IQCP are:
Risk Assessment (RA):
Risk Assessment is the first and most crucial element of IQCP. It involves a systematic process of identifying and evaluating potential risks that could affect the accuracy and reliability of test results. During this phase, laboratories examine all aspects of their testing process, including pre-analytical, analytical, and post-analytical phases. This assessment considers factors such as the test methods used, the environment in which testing occurs, personnel qualifications and training, specimen types, and equipment and reagents used. The goal of the Risk Assessment is to identify all potential sources of error or failure in the testing process and determine the likelihood and impact of each risk. This comprehensive evaluation helps laboratories pinpoint specific areas that may require enhanced QC measures or process improvements.
Quality Control Plan (QCP):
The Quality Control Plan is developed based on the findings from the Risk Assessment. The QCP outlines specific quality control procedures and practices that a laboratory will implement to mitigate identified risks. This plan is individualized to the laboratory's specific needs, taking into account the unique characteristics of the test methods and the laboratory environment. The QCP specifies the types and frequencies of QC measures, such as the use of control materials, calibration checks, and proficiency testing. It also includes criteria for acceptable performance, corrective actions to be taken when QC criteria are not met, and documentation requirements. The goal of the QCP is to ensure that any identified risks are effectively managed, and the laboratory consistently produces accurate and reliable test results.
In other words, this is where you say you are running QC once per 7 days or once per 30 days. Just remember to backup what you are claiming is safe with data. So, for a 30-day IQCP, include 30 days of QC being run every day to show that it is consistent.
Quality Assessment (QA):
Quality Assessment is the ongoing process of monitoring and evaluating the effectiveness of the IQCP. This element involves regular review and analysis of QC data, as well as periodic re-evaluation of the Risk Assessment and QCP. Laboratories continuously collect data on QC performance, error rates, and test result accuracy to determine whether the implemented QC measures are adequately controlling the risks. If deficiencies or unexpected outcomes are identified, the laboratory may need to revise the QCP or implement additional measures. QA also includes reviewing staff competency, equipment maintenance records, and adherence to standard operating procedures. The continuous nature of QA ensures that the IQCP remains relevant and effective over time and that the laboratory can promptly respond to any changes in the testing environment or procedures.
Now What?
Now the QC must be monitored according to your plan. So, if your plan says you’re going to monitor it by reviewing QC, proficiency testing, and personnel annually, then produce reports yearly reviewing these. Have your Laboratory Medical Director sign these.
Remember, if you have tests are used less frequently than once per month, it may be advantageous to only perform QC when you have a patient or proficiency sample.
Helpful hints:
Ask the manufacturer of a test if they have any materials for an IQCP. Often, they have a risk assessment that you can adapt. Just remember to create all three elements.
Here Is What You Are After. An Example Template of an IQCP!
Now you have all the tools you need to build an IQCP fit for your lab. Don't say I never gave you nothin'.
Comments