According to RDC 302:2005 of ANVISA, the External Quality Control – EQC (or Proficiency Test) is defined as the ANALYTICAL SYSTEM PERFORMANCE EVALUATION THROUGH PROFICIENCY TESTS and the clinical laboratory should perform EQC for ALL EXAMS PERFORMED IN THEIR ROUTINE.
The legislation also states that EXTERNAL QUALITY CONTROL SAMPLES SHOULD BE ANALYZED THE SAME WAY AS THE PATIENT SAMPLES.
That is, the objective of the External Quality Control is to verify the REAL PERFORMANCE OF THE LABORATORY using the control samples of the PRO-EX as a result SAMPLING of the patient samples of the laboratory, as happens in routine work.
Therefore, if the results of the PRO-EX are correct and their performance is excellent, the results of their patients will also be.
But generally, the processing of control samples differs from that given to patient samples. Many laboratories, aiming to achieve a high percentage of correct answers in the Monthly Evaluation, open new kits, calibrate the equipment, perform the tests in duplicate/triplicate and for the virtual samples, several professionals of the team analyze the images and discuss the result. Sometimes the technician in charge contacts a colleague from another lab to check if the results match!
Do you process patients' samples this way, too? In duplicate, with a new kit and calibrating the equipment? The answer, of course, is NO!
Thus, if the EXTERNAL QUALITY CONTROL SAMPLES SHOULD BE ANALYZED THE SAME AS THE SAMPLES OF THE PATIENTS, the laboratory described above is not meeting this mandatory requirement by law.
If you treat your control samples differently from patient samples, we regret to inform you, but your laboratory is not aware of its actual performance and cannot guarantee excellence in your patient's results, even if you get 100% success in the PRO-EX!
So, we invite you to proceed properly from now on by treating the PRO-EX kit in the same way you treat patients!
Once the PRO-EX arrives in your laboratory (as if it were the patient arriving at the reception), register the kit in your Laboratory Computer System - LCS, with the Batch identification (e.g. PRO-EX Lot 385), including all the examinations provided in the PNCQ worksheets and generating the usual work maps, labels, deadlines for releasing results and reports, thus conferring the necessary traceability of all processes related to control sample, as with patients. There is no collection, but a reconstitution of the lyophilized material with Reagent Water, which must be done according to the instructions in the worksheets. The PRO-EX control sample must enter the laboratory routine in sequential order and processed only once! The criteria for results evaluation, repetition, etc., should be the same as those applied to patient samples.
In this way, your laboratory will get a real evaluation of your performance and, consequently, you will achieve the necessary safety in releasing the results of all your patients.
With these clarifications, we expect you to proceed as indicated with the PRO-EX kit next month and upon receipt of the Monthly Assessment:
· If your hit percentage indicates excellent performance, great! It means you can safely release your patient's results.
· If your hit percentage indicates otherwise, it means that adjustments need to be made in your routine. And if you need help, contact us!
Check out more QUALITY TIPS soon!