PRE-EQC: A Proficiency Testing Program for Pre-Analytical and Analytical Monitoring Using Pooled Samples without Preservatives

Abstract

Aim: External Quality Assurance (EQA) is basic requirement of a medical laboratory to assess the quality assurance and achieve the accreditation. The available EQA schemes evaluate the analytical performances of the laboratory but neither evaluate pre analytical factors nor mimic actual laboratory process. PRE-EQC has combined both performances in single scheme and assisting the participant laboratories to take appropriate corrective action and interpretations. Design: Pre-Analytical monitoring evaluates transport condition, correlation of the stability of samples and temperature, storage condition and environment of the laboratory of the participants and its effect on the results. A sample is specially prepared to estimate haemolysis, lipemic and icteric index. Clinical Biochemistry: Serum, fluoride and biological fluid (CSF exempted) samples are pooled from the routine collection of specimens. Pooled fractions are homogenized in a rotary shaker for 10 minutes. The clear samples are poured in individual double pack primary containers, which are placed between two gel packs in a “biohazard” labelled plastic bag. Temperature is recorded, kept in insulated thermocol box and sent to the destination. Urine Routine & Microalbumin, Creatinine Examination: Urine sample is stabilized using preservative. Methods: The process of sample pool to result submission has been completed within 6 days as samples are without preservative. Stability mimicking the transport, homogeneity and validation of assigned values were done. Statistical Calculations: As per ISO 13528:2015. Results and Discussion: The SD of the assigned values showed better performance than existing schemes and within the range of CLIA recommended SD. Conclusion: The PRE-EQC sample from direct and microalbumin from direct specimen has achieved good reproducibility than lyophilized material.