Function evaluation of the autoanalyser internal quality control of the Kehua Polaris c2000 automatic biochemical analyser

Evaluation of the Kehua Polaris c2000 autoanalyser quality control system

  • Yiyi Wang Shanghai Shuguang Hospital Affiliated with Shanghai University of TCM
  • Lei Shi Shanghai Shuguang Hospital Affiliated with Shanghai University of TCM
  • Jue Zhang Shanghai Shuguang Hospital Affiliated with Shanghai University of TCM
  • Chen Chen Shanghai Shuguang Hospital Affiliated with Shanghai University of TCM
Ključne reči: Polaris c2000 automatski biohemijski analizator, klinička biohemijska detekcija, unutrašnja kontrola kvaliteta, vreme preokreta

Sažetak


Cilj sadašnje studije je (1) procena autoanaliserskog modula kontrole kvaliteta (QC) modula Kehua Polaris c2000 automatskog modularizovanog biohemijskog analizatora i (2) provera uticaja automatske implementacije internog QC (IQC) testiranja na određenu vremensku tačku na rezultate IQC-a i vremena preokreta (TAT). Metode: Pet uzastopnih dana korišćene su tri različite metode za sprovođenje IQC-a. 1. metod: Interni QC je izvršen u 8:00 svakog dana. 2. metod: QC proizvodi su stavljeni u instrument kalibraciju QC ploče u popodnevnim časovima, a instrument je postavljen da automatski meri proizvode u 7:00 sledećeg dana. 3. metod: QC proizvodi su stavljeni u QC ploču za kalibraciju instrumenta, a instrument je postavljen za automatsko merenje u 7:30 svakog dana. Sva tri metoda su upoređivana i ocenjivana. Efekat IQC-a na TAT je praćen pomoću 2. Rezultati: Nije bilo statističkih razlika u IQC rezultatima između metoda 2 i 1. Međutim, u nekim stavkama su postojale statističke razlike između rezultata metoda 3 i 1; tako se mogu usvojiti IQC rezultati metoda 2. Implementacija metoda 2 za IQC može pomoći u postizanju značajne TAT uštede od 35,23 min tokom procesa automatskog ponovnog testiranja nakon što IQC ukaže na van kontrole situaciju. Ovo vreme smanjenje je veoma dragoceno za poboljšanje efikasnosti i pojednostavšavanje toka posla za testiranje. Zaključak: Korišćenje autoanaliser QC modula sistema automatske biohemijske analize Kehua Polaris c2000 za izvođenje IQC testova nema uticaja na rezultate IQC testova i može spasiti TAT, kao i automatski ispraviti većinu van kontrole pojavljivanja.

 

 

Reference

[1] Liu SM, Zhou Q, Ma XY. Discussion on Internal Quality Control in Medical Laboratory[C]. Compilation of papers of the second China Clinical Microbiology Conference and Microbiology and immunology Sanjiang Forum. 2011:233-234.


[2] Cong YL, Qin XL. An Introduction to the Clinical Laboratory, [M]. Beijing: China Medical Science and Technology Press, 2004:1-10.


[3] China National Accreditation Council, CNAS-CL02 Accreditation Criteria for the Quality and Competence of Medical Laboratories (ISO15189:02) [S], Beijing: China Standard Press, 2012.


[4] Han Zn, Lin RW, Luo MK. Research on the Effect of Quality Control Management Applied to Blood Samples Tested. Modern Diagnosis and Treatment, 2014,11 (2): 2411-2412.


[5] Chen JF. Methods and measures of quality control management during the whole process of blood sample test. Contemporary Medicine, 2014,27 (21): 25-26.


[6] Tang NA. Performance verification of the Roche cobas c702 automatic biochemical analyzer. Laboratory Medicine and Clinic, 2019,37 (4): 632-634.


[7] Ji XC. Methods and measures of quality control management during the whole process of blood sample test.t.  Guide of China Medicine, 2017 (7): 163-164.


[8] He W. Analysis of the whole-process quality control measures of biochemical inspection. Gansu Science and Technology, 2017,5 (2): 53-55.


[9] Zhao ZJ, Guo YF. Clinical Application Evaluation of Mindray BS-400 Automatic Biochemical Analyzer. China Medical Herald, 2008,29 (35): 77-78.


[10] Qiu YF, Tong HC, Xie XX. Quality Control Analysis of Automatic Biochemical Analyzer Before and After Detection. Inspection and Quarantine Journal, 2019,29 (04): 102-103.


[11] Zhao L, Liu XL, Sui J. Analysis of Quality Control Measures for Clinical Biochemicaltest. Chinese Health industry, 2015 (18): 1-3.


[12] Ju DY, Yang C, Zhang LL. Biochemical inspection of internal quality control and method analysis. Chinese Health Industry, 2019,16 (30): 152-153.


[13] Xu S, Huang XD, Li XH. Study on the function of the quality control mode of clinical biochemistry examination in the laboratory information management system. Clinical Journal of Chinese Medicine. 201624:142-143.


[14] Xu HQ, Liu YP, Fu WL, Huang JF, Huang Q. Development and application of auto biochemistry analyzer made in China. Chinese Medical Equipment Journal, 2017,38 (09): 112-115.


[15] James O.Westgard, Hassan Bayat, Sten A. Westgard, Planning Risk-Based SQC Schedules for Bracketed Operation of Continuous Production Analyzers. Clin Chem,64:2,289.

Objavljeno
2024/06/16
Rubrika
Original paper