In a medical laboratory, internal quality control (IQC) is the process of monitoring and ensuring the reliability and accuracy of test results within the laboratory’s own operations. This involves using control materials that mimic patient samples to assess the performance of the laboratory’s examination methods, reagents, and equipment.
One important aspect of IQC is the ability to detect variations that can affect the accuracy and reliability of test results. Lot-to-lot reagent variation refers to changes in the properties of reagents (chemicals used in tests) from one batch or lot to another. Similarly, lot-to-lot calibrator variation refers to changes in the calibration materials used to set the measurement scale of a test.
When conducting IQC, it’s important to be able to differentiate between variations caused by the examination method itself and those caused by changes in reagents or calibrators. To achieve this differentiation, the laboratory should avoid introducing multiple changes simultaneously. This is the concept explained in the statement you provided:
“The laboratory procedure should avoid lot change in IQC material on the same day/run as either lot-to-lot reagent or calibrator change, or both.”
Here’s why this is important:
- Isolating Variables: By avoiding simultaneous changes in IQC materials (the control samples), reagents, and calibrators, the laboratory can isolate the effect of each variable. This means that if there’s a change in the test results, the laboratory can more confidently attribute it to the specific change being investigated (e.g., reagent or calibrator change) rather than being confused by multiple changes happening at once
- Accurate Assessment: If the laboratory were to make changes to both the IQC material and the reagents/calibrators on the same day or run, any differences observed in test results might be due to either factor, making it challenging to pinpoint the source of variation accurately.
- Identifying Root Cause: Accurately identifying the source of variation is crucial for troubleshooting and corrective actions. If a problem arises, the laboratory needs to know whether it’s related to the examination method, reagents, or calibrators to take appropriate corrective measures.
To sum up, the statement emphasizes that to effectively monitor and manage variations in a medical laboratory’s test results, it’s important to separate changes in IQC materials from changes in reagents and calibrators. By avoiding simultaneous changes, the laboratory can better understand the impact of individual variables on the accuracy of its test results, allowing for more effective quality control procedures.
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
Very good