Quality Standard

Standardization efforts in laboratory medicine take priority

It is estimated that 60 to 70 percent of all decisions regarding a patient’s diagnosis, monitoring, treatment, hospital admission, and discharge are made on the results of the tests of medical laboratory. Therefore, the contributions of clinical laboratory screening and diagnostic tests to health care quality and outcomes are substantial.

Consequently, standardization efforts in laboratory medicine take priority which focused on the assignment of appropriate calibrator values that ensures comparability of test results, independence of the type of routine reagent – calibrator – control – analyzer combination that is used.

Routine medical laboratories seeking accreditation of measurement procedures must comply with the Quality Assurance Program which is promoted and developed by The International Organization for Standardization (ISO) and The Clinical and Laboratory Standards Institute (CLSI).

Quality Assurance Program in the medical laboratory is a system designed to increase the probability that each result reported is valid and can be used with confidence by the physician making a diagnostic or therapeutic decision. It includes Internal Quality Control (IQC) and External Quality Assurance (EQA).

Internal Quality Control (IQC) helps to daily monitor the device by testing a control material with a known value and limits. Tells you immediately whether the device is reliable to test patients.

External Quality Assurance (EQA) allows sites to check the quality of their results in comparison with other sites by testing an identical sample with an unknown value. As a Haemostasis specialized company, Stago offers an international EQA programs My Qualiris QC comprehensive range Qualiris, an international EQA programs My Qualiris QC, with large option including routine panel, specialties, new innovative parameters exclusivities (i.e. FM & Edoxaban) and the Diagnostic Challenge, an educational tool for training.

Particularly for the haemostasis testing, STAGO offers a new service My Expert QC for ONLY Stago customers using Stago’s Instruments, Reagents and IQC. It is a web portal available 24/7 for any PC, real-time comparison of IQC results with worldwide large peer groups. Graphic solutions for statistical exploitation of IQC results, performance comparison, visualization of trends, and troubleshooting.