Application and efficacy of patient-based real-time quality control in intralaboratory comparison of various hematology analyzers / 中华检验医学杂志

Objective:To evaluate the application value of patient-based real-time quality control (PBRTQC) algorithms in intralaboratory comparison between various hematology analyzers.Method:From April 1 st 2020 to March 31 th 2021, data of white blood cell (WBC) counts and daily comparison results of fresh venous blood, measured by five hematology analyzers, were collected at the Department of Laboratory Medicine in Hebei Children′s Hospital. First, the professional intelligent PBRTQC software system was applied to conduct the parameter setting, program establishment, and performance verification. Three concentration ranges of WBC were selected, low concentration (2.5-4.5)×10 9/L, medium concentration (6.0-8.0)×10 9/L and high concentration (12.0-14.0)×10 9/L for the comparison. Next, WBC counts were calculated with both of the EWMA and median methods, the results were then analyzed by PBRTQC using the module of"intralaboratory comparison of hematology analyzers". Finally, bias of intralaboratory comparison among various hematology analyzers analyzed by means of EWMA and daily comparison results of fresh venous blood were compared. Based on the standard of WS/T 406-2012,allowable error ±7.50% in WBC counts was set as the relative bias standard among different instruments. Results:(1) A total of 38 313 sample results were included, there were 70 warning results out of these samples based on the EWMA quality control method established on the data of patients with white blood cell count in our laboratory, with an early warning rate of 0.183‰, a probability of error detection of 100%, and a probability of false loss of control of 0. EWMA quality control efficiency met the quality objectives. (2) In the comparison monitoring of the results of 5 blood cell analyzers at high concentrations, the coincidence rate between EWMA and median method were both 100% (46/46) in weekly and monthly comparison, and EWMA could maintain a relatively stable monitoring efficiency in daily comparison. (3) In the selected natural month, the consistency rate between EWMA method and fresh blood comparison method was 95.24% (20/21).Conclusion:PBRTQC can be used as a valuable supplementary tool of IQC to continuously and effectively monitor the consistency of data derived from intralaboratory hematology analyzers with different bands and types, which can not only reduce the risk of quality and operating costs, but also improve the efficiency of laboratory management.

Establishment principles and research progress on patient based real time quality control / 中华检验医学杂志

Patient based real time quality control (PBRTQC) is a quality control method that uses the test results of clinical specimens from patients to monitor the analysis performance of the test process in real time and continuously. Although the International Federation of Clinical Chemistry and Laboratory Medicine PBRTQC working group had recommended that this method should be popularized in clinical practice in 2020, there is still certain lagging in cognition, research and application of PBRTQC in domestic clinical laboratories. This paper highlights the research progress, operation categories, clinical application value, domestic standard guidelines, PBRTQC procedure establishment, performance verification, implementation principles, application status and prospects of PBRTQC, so as to promote the recognition, acceptance, reference and wide application of PBRTQC in domestic clinical laboratories.

Theories and perspectives of patient-based real-time quality control system in the laboratory / 中华检验医学杂志

Taking advantage of current advancements of the laboratory information system, patient-based real-time quality control (PBRTQC) has become a hot research topic with the potential of significantly improving the quality of clinical laboratories. PBRTQC has several advantages over conventional internal quality control, including the merit of continuous error detection, low maintenance cost, and no fear of loss of quality control due to commutability issue. This review summarized the recent research progress in PBRTQC. The review described the fundamental theories of PBRTQC and explained how to implement PBRTQC in clinical laboratories in detail. The review also provided prospective view on how to solve the current problems and what are the future research directions of PBRTQC.