QC in the Laboratory

1393

: :" " FDA - - .

:" " FDA - - .. . : !Carraro P. Plebani M. Errors in a Stat Laboratory: Types and frequencies 10 years Later. Clin Chem 2007:53:1338 - 1342 4 Padova : 10 - : 62% - : 23% : 15%Carraro P. Plebani M. Errors in a Stat Laboratory: Types and frequencies 10 years Later. Clin Chem 2007:53:1338 - 134251,746 393 160 46 24 52%Carraro P. Plebani M. Errors in a Stat Laboratory: Types and frequencies 10 years Later. Clin Chem 2007:53:1338 - 1342

Q-Probe Quality IndicatorsNevalian D. et al. Evaluating laboratory performance on quality indicators with the six sigma scale. Arch. Pathol Lab Med 2000;124:516-519SM 4.00 4.15 4.25 3.85 4.80 : 2010 2005C. Cobbaeret et al. / Chlinca Chemica Acta 414 (2012) 234-2409

: R. Jansen et al. / Chlinca Chemica Acta ****(2013) ****10

D: 139011 : 204 HPLC-ACI-MS RIA CLIA: 8% 22% 44% D !: . : 12 ... = ! ! : Residual Risk : :17 : ! : 18 : :ISO: . :ISO 15189: . .! : :: : ...

ISO 15189: : :

5.5.1.1: .5.5.1.2: . :

1963 10% ( )A study of accuracy and precision of clinical laboratory determinations in 170 Canadian laboratories. Clin Chem 1963;9:217-2331968 Medical significance of laboratory results. Am J Clin Path 1968;50:671-6761974 : Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin Chem 1974;20:825-33 CAP-19761976 Aspen Conference on Analytical Goals in Clinical Chemistry

Clinical Chemistry 1999;45:321-3

1999:1- 2- : - (Biological Variation) - 3- :- - 4- :- - (EQA)5- (State of the art)- EQA - : ! :1- 2- : - (Biological Variation) - 3- :- - 4- :- - (EQA)5- (State of the art)- EQA - A1C 1) : 10% : 0.1% 25 Allowable Total Error; TEa ATE : ! 26: ( ): .27:

TEa 10% 80 28 = 80 ATE = 10%80 10% = 872 88 = 120 ATE = 10% 120 10% = 12108 132 PT = 20 ATE = 15%20 15% = 3 17 23 29 CLIAClinical Laboratory Improvement AmendmentsALT: 20%ALB: 10%ALP: 30%Glucose: 6 mg/dL or 10% (each one higher)Hb/HCT: 6%30 CLIAhttp://www.westgard.com/clia.htmEuropean Recommendations for Biologic Goals for Imprecision and Inaccuracyhttp://www.westgard.com/biodatabase1.htmRCPA Quality requirementshttp://www.westgard.com/rcpa-australasian-quality-requirements.htmRililbak German Guidelines for Quality???31 TEa TEa 32 : : 6.7% (67000 ) 3 : 3.4 6 : 5% (50000 ) !

33 :

TEa TEa : 95% . FDA :99% TEa 20%35 :TEa95%! ISO 15189: : :

5.5.1.1: .37 :TEa95%!: .

38 :

39 95% .

40 :

41SOP :

: : CSF :- -

42 TestUnitsReference IntervalDecision LevelsELECTROLYTES12345Camg/dL9.0-10.67.011.013.5MgmEq/L1.2-2.41.22.05.0Crtisolug/dL7-205101525Cholmg/dL TEa

2) TSH:B = 10%CV = 3%TE = 16%TEa = 20%; TE < TEa

:

74B + 2CV < TEa: 3) PT:B = 5%CV =6%TEa = 15%

2) Na:B = 1%CV = 0.2%TEa = 3%

CV = 0:Bmax = TEa

B = 0:CVmax = 1/2TEa

75

+TEa-TEaB = 0CVmax = TEaBmax = TEaCV = 0

CV = 0B = 0! Six metricsTEa = 30%Bias = 10%CV = 4

SM = 5ALP

6- / / ! Six metrics

3sigma7sigma

Six metrics

3sigma7sigma

Six metrics

3sigma7sigma: : : 19- 17- 14 : 12

:4 3 2 : Six metricsTE = B + 2CV

SM = (TEa B) / CV

}TE TE SM

81(SM)+ TEa- TEaTESMSM (DPM) (DPM) 236000 (3.6%)274000 (27.4%) 3270067000 4636000 50.623360.0023.4 Six metrics Six metricsTEa = 30%Bias = 10%CV = 4

SM = 5ALP

TEa = 30%Bias = 10%CV = 4 %TE = 18% SM = 5ALP

Six metricsTEa = 30%1)Bias = 1%CV = 8.5 SM = 3.42)Bias = 10%CV = 3 SM = 6.7

ALP

126.73.4 :TAE < ATE

:SM > 2

86 :TEa95%!87 SOP !! :: : ......

87ISO 15189: : .

5.5.1.1: .5.5.1.2: . 493.1256 CLIA : .

8889 : SQC : 95% TEa 5% .

: 5% TEa .9091+ TEa- TEa

SM = 4 SM = 3

2 : 92+ TEa- TEa

SM = 5 SM = 2.5 SM = 2 : TETETE9293- TEa

"" SM2Msafe+ TEa94+ TEa- TEa

"" SM2Msafe! ( ) 4 1:2s/1:3s/2:2s/R4s/4:1s/8x : TSHTEa = 20%95 (SM)3.812.126.531.7548.55

: TSHTEa = 20%96 (SM)3.812.126.531.7548.55

20% +20% - TSH8.5 1.75 6.5 2.1 3.8 : TSHTEa = 20%97 (SM) 3.812.126.531.754 !8.55

: / 98 :

1) 100% Ped = 100%

2) 0% Pfr = 0%

99! :

Ped 90%

Pfr 5%

100101 Power Function Graph

:

:

102103

CLSI C24-A3. Statistical Quality Control for Quantitative Measurement Procedures. 2006

104SM3456CLSI C24-A3.

1053456

106 : : 106107 : 90% HI-Ped Mod-Ped Low-Ped 50 - 90%< 50%Ped ? (AQCS)108Hi-Ped 90%Mod-Ped 50% Low-Ped