Quality Control Third Party Controls and Regulatory Standards

Third Party Controls and Regulatory Standards NCCLS • • • Controls should be of

내부 정도관리 (QC material 사용) 1. Xbar- R 관리도 2. 쌍치법 (twin-plot, youden-plot) 3.

QC definition of Terms 9) CVR (Coefficient of variation ratio) * Peer group 과

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Quality Control 김대중

Third Party Controls and Regulatory Standards NCCLS • • • Controls should be of the same matrix as patient sample Controls levels should be at clinically significant levels Controls need to be different from calibrators Laboratories are encouraged to establish their own means and ranges Laboratories are encouraged to participate in an inter-laboratory program

내부 정도관리 (QC material 사용) 1. Xbar- R 관리도 2. 쌍치법 (twin-plot, youden-plot) 3. 누화법(Cu-sum method) 4. 변동 계수법 (C. V method)

QC definition of Terms 9) CVR (Coefficient of variation ratio) * Peer group 과 performance 비교시 * CVR = (실험실 CV)/(Peer group CV), Target CVR = 1 10) SDI (Standard Deviation Index, 표준 편차 지수) * Peer group 과 performance 비교시 이용, Target SDI = 0 * SDI = (실험실 평균 - peer group 평균)/peer group SD 11) VIS (Variance index score, 변동지수 점수법) %Variation =V = ((참여기관보고치-검체의 참값)/100 VI = V/CCV(Chosen coefficient of variation)*100

QC&Troubleshooting

QC&Troubleshooting

Trend R 4 s Rule

10 X tri levels Cal 문제

QC&Troubleshooting

QC&Troubleshooting

The End