ABSTRACT
Objective To improve the quality of clinical biochemistry laboratory by quality indicators of pre-analytical,analytical,post-analytical phase and the whole process.Methods Analytical Phase:The Sigma values of items were calculated,applying the equation Sigma =(TEa％-Bias％)/CV％.Total allowable error (TEa) is from analyticalal specification defined in WS/T403-2012 of China,Bias％ is from the evaluation results of National Center for Clinical Laboratory (NCCL) trueness verification PT series and CV％ is from internal quality control data during the last 6 months in our lab.Normalized Sigma metrics plot was made to evaluate the analysis performance and the quality control strategies were designed accordingly.The quality goal indexes (QGI) were also calculated to propose improvement measures for items below 6 Sigma.Quality indicators of pre-,post-analytical and whole analytical phase,such as quality of specimen,critical value notification,critical value notification in time,TAT of hs-cTnT,TAT of emergency biochemical items,rewrite of laboratory reports and unacceptable performance in EQA-PT were measured in Sigma metrics too.The Sigma metrics changes before and after taking improvement measures were compared to conform the effectiveness.Results The average Sigma value of 17 biochemical tests was 5.29,of which 8 items (UA,K,ALP,CK,AMY,AST,TG,Na) achieved excellent to world class level (≥ 5 Sigma),6 items (LDH,Cre,TC,ALT,Mg,Glu) achieved marginal to good level (5 ＞ Sigma ≥ 3),BUN performed poorly (3 ＞ Sigma ≥ 2),Ca,TP performed unacceptably (Sigma ＜ 2) with serious quality defects.The Sigma values of unacceptable specimen,critical value notification,critical value notification in time,unacceptable turn around time (TAT) of hs-cTnT,unacceptable turn around time (TAT) of emergency biochemical items,rewrite of laboratory reports,unacceptable performance in EQA-PT were 4.17,3.60,2.75,1.72,3.27,4.52,3.33 respectively,rising to 4.30,4.30,2.90,2.45,3.75,4.80,3.60 accordingly after improvement.Conclusions Sigma metrics is potentially an ideal approach for clinical biochemistry laboratories management,which is helpful to find out problems,put forward improvement measures,and confirm the effectiveness,so as to achieve the purpose of continuous quality improvement.
ABSTRACT
Objective To explore the situation of respiratory virus co-infection with EV71 and CA16 in patients with hand,foot and mouse disease(HFMD) ,and analyze the influence of co-infection on clinical aspects.Methods From June to October of 2010,there were 348 patients enrolled in the study,with 248 hospitalization cases and 100 mild outpatients.All the patients were diagnosed as HFMD in Beijing You-an Hospital.The viral RNA from the pharynx swab samples were extracted and reversely transcribed by RT-PCR.All the samples were detected with the EV71 and CA16 by real-time fluorescence quantitative PCR.Twelve kinds of respiratory viruses were detected by a commercial multiplex-PCR method.The PCR products were confirmed by electrophoresis.Chi square test was used in the data analysis.Results Of the 348 HFMD patients,36 subjects were detected as positive for respiratory virus co-infection.In the 248 hospitalization cases,111 cases were positive for EV71 or CA16,with eight cases identified with respiratory virus co-infection(7.2%); the other 137 cases were negative for EV71 and CA16,with eleven cases identified with respiratory virus co-infection(7.4%).There was not significant difference between respiratory virus co-infection and the identification of EV71 /CA16(x2 = 0.059,P ＞ 0.05).In the 100 mild outpatients positive for EV71 or CA16,seventeen cases were identified with respiratory virus co-infection(17%).The rate of respiratory virus co-infection in the mild outpatients was much higher than in the severe hospitalization patients(x2 = 4.830,P＜ 0.05).Among the 111 EV71(+) or CA16(+) inpatients,there were 101 cases diagnosed as severe cases(91.0%); similarly,there were 132 cases diagnosed as severe cases(96.4%) among the 137 EV71(-) CA16(-) cases.There was not difference between the identification of EV71/ CA 16 and illness of HFMD(x2 = 3.099,P ＞ 0.05).The leading respiratory virus being identified were HRV A/B,PIV3 and FLU A in the 348 HFMD patients.Conclusions Co-infection with respiratory virus exists in the HFMD patients. However,the respiratory virus infection has no significant influence to the state of HFMD illness.