Test your IQCP IQ
By Jim Poggi, Principal, Tested Insights
This month, we are going to take a deep dive into Individualized Quality Control Program, or IQCP. I am going to abbreviate it to “IQC” for the balance of this column for simplicity. As moderate complexity labs develop experience and confidence in their analytical system, some look for opportunities to perform quality control, not just for their testing systems but across their entire lab under carefully controlled and managed parameters.
There are leading manufacturers of lab equipment that provide specific programs for our customers to develop and successfully implement an IQC program. These manufacturer programs typically include guidance documents, software and/or on-site consultation to provide assistance as needed to make the IQC program a success.
This column is not intended to provide a specific listing of manufacturers and instrument systems which provide IQC support. Rather, it is intended to familiarize you with the basics of IQC so you understand the fundamentals well enough to seek out expert assistance from your lab instrument manufacturer. In addition to manufacturer support, there are a number of excellent third party resources available to you and your customers including several reference materials from the Centers for Disease Control and Prevention (CDC), who offers a primer on IQC, a guide to understand the needed steps to implement a program and also a guide book to walk the customer step by step through the analytical process and evaluation of the lab’s readiness and risk assessment to implement an IQC program.
When you encounter a customer with questions about IQC, your best option is to contact your trusted lab instrument manufacturer, learn more about the IQC options and support they offer to be prepared for customer discussions regarding this option along with their instrument manufacturer. Customers considering an IQC program are typically motivated by the desire to use the most up-to-date approach to daily QC (typically recommend in the instructions for use of most lab instruments) while also recognizing and controlling all sources of error and variability in their lab to assure the highest quality of lab results.
In my opinion, the most fundamental benefit to a lab considering an IQC program is the thoughtful analysis of its current performance and a system-by-system risk analysis, including pre-analytical steps, the analytical process, personnel standards and performance and finally result reporting. Whether an individual lab eventually decides to implement IQC or not, the results of this comprehensive analysis will result in a lab that preforms at a higher level of efficiency and confidence. Arguably, this process also helps the lab to identify any weaknesses in its overall system performance, correct them and provide exceptional patient results.
What is IQC?
IQC is known as an “Individualized Quality Control” Plan. It is recognized under CLIA as an acceptable adjunct to the quality control recommendations of your lab equipment manufacturer, utilizing a carefully conducted planning and implementation protocol to assure result quality by implementing such a program. There are three key elements of developing and implementing an IQC program: Risk analysis, QC plan, and quality assessment.
Risk analysis
A proper analysis, often with the active assistance of your trusted lab instrument manufacturer, looks at each element of the lab’s performance, understands its strengths and needs for improvement, and uses the risk assessment to shore up areas of the lab where a greater level of control will lead to better results. The baseline analysis requires a complete in-depth understanding of the instructions for use for each of your lab instruments. This risk analysis typically begins by breaking down the lab’s performance into its three major components: pre-analytical, analytical and post analytical/result reporting.
Each system is analyzed to assure it is properly managed. As an example, in the pre-analytical system assessment, is room temperature controlled in accordance with lab instrument manufacturers’ requirements? Are samples stored at the appropriate temperature and analyzed during the window required by the manufacturer’s instructions for use? In the analytical system assessment, is instrument maintenance performed at the right intervals? Have reagents been used and lots managed according to manufacturer directions? Has lot to lot performance been consistent?
Testing personnel qualifications, training and assessment and conformance to the lab’s policies and procedures are also part of understanding and assessing the analytical process and its performance. While not specifically called out in some of the IQC protocols I have reviewed, an assessment of result reporting is also important. Are results reviewed according to the lab’s policies and by the appropriate personnel? How are quality control result issues rectified before reporting patient results? Is test result information maintained under HIPAA requirements and are results readily available to clinicians and patients in a convenient easy to understand format, such as the patient portal?
The QC plan
The quality control plan looks at the variables and sources of potential error identified in the risk analysis and builds policies, protocols and systems to address them and create a comprehensive quality program across the entire laboratory. The QC plan becomes the systematic backbone intended to create an assurance that lab test results are of the highest possible quality. It will address environmental issues, such as temperature control in the lab and quality of physical space for the testing performed. It needs to address maintenance of the large analytical instruments but also the pre-analytical equipment. Maintenance of rockers, rotators, centrifuges, refrigerators and freezers are all considered in the quality control plan. Personnel qualification, duties, responsibilities, periodic assessment and training and key elements of the plan as well. Finally, instrument quality control procedures, including acceptable QC variability, steps required to be taken when QC appears out of control, and result reporting are all considered in the quality control plan.
In essence, the QC plan is the lab’s overall policies, procedures and document of how it is managed under CLIA for optimal result quality. A lab with highly motivated and qualified staff may well develop a QC plan with limited assistance from the lab instrument manufacturer or other outside sources, but the best plans typically include input from a variety of sources. As an aid to documenting the quality control system and plan, there are several excellent software programs that highlight each needed policy and procedure required for high level lab performance and provide a simple and easy platform to create, review, and maintain this information for ready access to lab personnel at all times.
Quality assessment
The final element of a well designed and implemented IQC program is the creation of a feedback loop to answer the questions. Did the risk analysis uncover the key gaps in our quality program? Did the new Quality Control program successfully address those issues and are they resolved?
An important additional question needs to be “Have we uncovered any new issues that need to be addressed?” If so, we will need to revise our QC program and run the feedback loop over again.
As you can see, the three elements of the IQC program work together. There is analysis as the first step. Corrective action is the second step. Assuring that the corrective action has resolved the issues uncovered in the analytical phase is the third step.
In a perfect world, no IQC program would be static. It would be subject to review and revision from time to time as circumstances change or as the lab personnel determine that there are new issues to consider or even new solutions (such as new supplier recommendations or new software solutions) that can improve processes and documentation of the quality system.
The key to a well-functioning lab is change management. Be involved with your key lab manufacturers and your lab customers and work together to offer solutions to optimize their lab organization and results. Discussing IQC options first with your key lab manufacturers and then selecting the right customers to offer IQC as a solution will help you maintain your credibility as their preferred lab consultant.