Imagine a medical laboratory that performs blood glucose testing using a glucose analyser. The laboratory’s intended purpose is to accurately measure blood glucose levels in patient samples to assist in diagnosing and managing diabetes. As part of their quality control procedures, they need to select appropriate internal quality control (IQC) material.
“The laboratory shall select Internal quality control material that is fit for its intended purpose.”
In this context, here’s how this principle applies:
- Intended Purpose: The intended purpose of the IQC material is to serve as a control sample that mimics patient samples and allows the laboratory to monitor the performance of its blood glucose testing method. The IQC material should exhibit similar characteristics as patient samples and cover the range of glucose concentrations that the laboratory typically encounters.
- Selection Criteria: To ensure the IQC material is fit for its intended purpose, the laboratory needs to consider factors such as concentration range, stability, matrix compatibility (similarity to patient samples in terms of composition), and expected frequency of use.
For instance, if the laboratory’s blood glucose analyser is used to measure a wide range of glucose concentrations (from very low to very high), the selected IQC material should ideally cover this entire range. If the material is stable over time, it can be used for a longer period before needing replacement. Additionally, the matrix of the IQC material (its composition and properties) should closely resemble that of actual patient blood samples to provide accurate control.
- Accuracy Monitoring: The IQC material should provide accurate and reliable results when tested on the blood glucose analyser. It’s used to verify that the analyser is producing accurate results within acceptable limits. Any deviations from expected values can signal issues with the analyser’s performance, reagents, or other factors.
- Frequency of Use: Depending on the laboratory’s testing volume and workflow, the frequency of using IQC material might vary. Some laboratories use IQC material with every run, while others use it at regular intervals. The selected IQC material should be practical and economical to use based on the laboratory’s needs.
- Documentation and Traceability: The laboratory should maintain records of the IQC material selected, its properties, concentrations, and any relevant documentation provided by the manufacturer. This ensures traceability and accountability in case of quality control audits.
In summary, selecting IQC material that is fit for its intended purpose involves choosing a control sample that aligns with the characteristics of patient samples and the testing method’s requirements. It ensures that the laboratory can effectively monitor the accuracy and reliability of its test results, which is crucial for patient diagnosis and treatment decisions.
About the author
Dr. Sambhu Chakraborty is a distinguished consultant in quality accreditation for laboratories and hospitals. With a leadership portfolio that includes directorial roles in two laboratory organizations and a consulting firm, as well as chairmanship in a prominent laboratory organization, Dr. Chakraborty is a respected voice in the field. For further engagement or inquiries, Dr. Chakraborty can be contacted through email at director@iaqmconsultants.com and info@sambhuchakraborty.com. Additional resourcesand contact information are available on his websites, https://www.quality-pathshala.com and https://www.sambhuchakraborty.com, or via WhatsApp at +919830051583
Great blog!
So when we receive an IQC material, what is the Acceptance and Rejection criteria?
Thanks