In an industry presentation, Dr Anjali Singh, Medical Advisor Bio-Rad Laboratories India (Pvt) Ltd shared her views about ‘Role of Quality Control in Improvement of Laboratory Testing & Patient Outcomes’. Edited Excerpts:
Quality Control (QC) has been talked about for quite some time now and Bio-Rad has been associated with this product education, hand holding as well as association with major institutes for over two decades now. Dr Anjali Singh, Medical Advisor Bio-Rad Laboratories India (Pvt) Ltd shared the basics of QC.
She talked about how the entire patient impact comes from a number that labs give out in their report and how that number is dependent on multiple factors, for which they work day in and day out.
She also gave an example of an instance when a report has poor quality and how it can lead to inappropriate action for the patient, one can over investigate the patient when they don’t require so many investigations; high costs, harassment involved for a sick patient or the patient can also be over treated or even given a wrong treatment. She also shared how there can be delay in action if the report is to be repeated or done in another lab for confirmation, which can lead to loss of credibility of the laboratory. She added that legal actions can also be taken against the laboratory.
She shared her views on how does a lab ensure good quality results and how can a lab ensure or demonstrate to their patients that their reports are correct? She stated that there are certain materials that help like mimicking the patient’s sample.
We run it before running any patient’s sample, if the results are okay we assume that most likely the patient report is going to be okay. If the results are not okay, patients’ results may be compromised,” said Dr Singh. She further elaborated that by the term mimic, it is meant that it should have a similar matrix to patient samples, should be independent of any one instrument, different from calibrator, cover the clinical decision values, should be easy to use, stable for long periods and have at least 2 levels.
She elaborated that once all these materials are available and they run this QC material. And if the value of this material is as expected the value to be, then it is believed that their instrument is fine and their patient report is correct. If the QC value is not as expected, then patient testing is stopped. “We first investigate the problem, QC is rerun and if the QC is okay then only we run the patients sample.
There are various causes that can lead to wrong reports, such as instrument maintenance; change of instrument part; major repair of instrument; change of reagent lot; recalibration; calibration failure; change of light source; change in incubation temperature (for enzymes only); failure of reagent dispensing system; failure of sampling system and change in environment (temperature/ humidity).
Sometimes, we see the values are close together but they are not the real values, true values and it is impossible to find the true value from IQC because IQC is repeatable,” said Dr Singh.
She also averred that even after using QC there is a possibility that lab reports do not match with other lab reports. “And the question arises that why our lab are reports not matching? There comes the concept of EQAS (External Quality Assurance Scheme), so believe that our report has to be accurate, that is near the value that is expected and it has to be precise that is if we repeat it ten times, it still gives the same outcome,” said Dr Singh.
She shared that if a lab is accredited, the accrediting agencies come and perform regular audits, check if QC was run at required frequency, was corrective action taken in case of QC failure and if any patient tests were done if QC was not ok.
She added that QC is an important step in maintaining quality of patient testing. Both internal and external QC are equally important/ one cannot substitute another. As a clinician, an accredited lab can be believed to be running QC at required frequency.