Document Type: Original Research

Authors

1 Dept. of Pathology, Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

2 MDS laboratories/Auto lab Systems, Etobiocoke, ON, Canada .

Abstract

  Background and Objective: Improved and modified automation will require the development of smart process control systems that provide on-line decisions to release patients’ test results based on high analytical quality assurance formula. Materials and Methods: We collected patients’ test results from 10840 healthy subjects based on 1.96z as truncation limit for 29 common haematochemical analytes at a regional reference laboratory. Computer simulation studies by EZ rulesTM and EZ runsTM software were performed to generate operating specification charts (OPSpces) that consider truncation limits set at 3() and control limits set at 3and number of patient subgroups which varied from 10 to 480 depending on the ratio that varied from 1.58 to 19.75. Results: On the basis of the test parameters defined and the workload expected in our  regional laboratory, average of patients (AOP) algorithms would be expected to be useful for monitoring run length on analytical systems that test for ALP, ALT, AST, total bilirubin, calcium, creatinine, glucose, hematocrit, hemoglobin, potassium, sodium,  TSH and urea. These tests provide high potential capability indicating low, high and high analytical quality assurance (AQA) with low control observations for applying AOP algorithms to monitor run length. Conclusion: Our investigation revealed that approximately fifty percent of commonly requested haematochemical tests could achieve high capability in order to establish AOP method to maximize analytical run length.  

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