The How, What and When of Quality Control in laboratory
In the realms of clinical chemistry and hematology, precision and accuracy are paramount. Whether one is conducting diagnostic tests, analyzing blood samples, or assessing the chemical composition of substances, the results obtained play a critical role in patient care and various scientific endeavors. This is where quality control steps in, ensuring that the data generated is not only reliable but also consistent over time.
How to Implement Quality Control
Implementing quality control in biochemistry and hematology involves a series of systematic steps. It begins with the selection of appropriate control materials. These materials should mimic the characteristics of patient samples as closely as possible. Next, establish a documented quality control plan that outlines the frequency of testing, expected ranges, and actions to take when results fall outside these limits.
Regular calibration of instruments is a fundamental component of quality control. Instruments drift over time, and calibrations ensure they remain accurate. Quality control samples should be run alongside patient samples, allowing for the identification of any discrepancies. Repetition of testing and recalibration may be necessary when such discrepancies are identified.
It’s important to maintain a thorough record of quality control data. This includes documenting the dates of testing, the names of individuals performing the tests, and the results obtained. This record-keeping is vital for identifying trends and for audits or inspections.
What to Control
Quality control encompasses two primary aspects: precision and accuracy.
Both precision and accuracy are essential to ensure reliable data.
In biochemistry, quality control measures should address factors like reagent stability, contamination, and instrument performance. In hematology, control measures focus on maintaining the accuracy of cell counts, identifying abnormal cell populations, and ensuring the reliability of hemoglobin and hematocrit measurements.
Ensuring accuracy
Accreditation from both CAP and NABL (ISO 15189) serves as a seal of approval for clinical laboratories, affirming their capability to consistently uphold global quality standards in clinical testing and interpretation at all their facilities. The CAP laboratory accreditation program holds international recognition, empowering laboratories to attain the utmost standards of excellence, ultimately enhancing the quality of patient healthcare.
Patient well-being and care, as well as the quality of laboratory services, remain paramount. NABL, as the sole government-authorized laboratory accreditation body in India, aligns its processes with ISO 15189:2012 standards, further endorsing the commitment to upholding quality and precision.
When to Perform Quality Control
The timing of quality control tests varies based on the specific instruments and the complexity of the tests being performed. However, there are general guidelines that can be followed. Routine daily quality control is essential, ensuring that instruments are in optimal working condition before testing patient samples.
Additionally, control samples should be analyzed whenever there is a change in reagents, new lots of control material, or when instruments undergo major servicing or maintenance. This helps validate the performance of the instruments and the reagents being used.
For long-term quality control, trend analysis is a valuable tool. By comparing historical data, labs can identify shifts or trends in results, even if they fall within the established control limits. This allows for proactive measures to be taken to maintain the quality of results over time.
- Quality control is the linchpin of reliability and consistency in chemistry and hematology. By following established protocols and ensuring precision and accuracy, healthcare professionals and scientists can be confident in the results they generate. In the field of laboratory service, where accuracy is a matter of life and death, quality control is not just a good practice; it’s a necessity.
