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07/09/2018 Analytical Risk Assessment

Analytical Risk Assessment Dr Joaquim Chaves Lab. A. C.;Dr Joaquim (825214)


Av General Norton de Matos 71
ALT (ALAT/GPT) . U/L Lisboa, , 1495
Roche cobas 8000 (125603) Portugal

Risk Analysis QC Strategy


A Risk Management Index (RMI) ≤ 1 indicates Managed Risk. 1:4s QC rule
RMI = 0.005 Single replicate, 2 levels of QC (1 QC’s)
In-Control RMI = 0.001 Evaluated every 300 specimen tests for analyte
     Imprecision RMI = <0.001 False rejection rate = 0.013 %
     Bias RMI = <0.001 Expected Time between False Rejections = 7,894 days.
Out-of-Control RMI = 0.004 QC Rule Statistics
Maximum RMI = 0.018, occurs at Systematic Error (SE) 5.14, it is expected to take 12.1 QC events to detect. Mean SD Reference Mean
Risk Parameters Level 1 27.5 (Lab) 1.21 (Lab) 27.2 (Peer)
Severity of Harm Category: Minor Level 3 182 (Lab) 3.65 (Lab) 185 (Peer)
Acceptable Probability of Harm: 0.001
Performance
Probability of Harm from Erroneous Result: 5.00
Allowable Total Error (TEa) = User Defined 15.1%
Reliability Average Sigma Metric = 5.85
Mean Time Between Failures (MTBF): 20 days
Test Method Statistics
300 Patients per day
Lab Mean Lab SD Lab CV Lab Sigma Peer Mean Peer SD
Mean Patients Between Failure (MPBF): 6000
Level 1 27.5 1.21 4.41 3.14 27.2 1.25
Level 3 182 3.65 2.00 6.94 185 5.85

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07/09/2018 Analytical Risk Assessment

RMI = 0.00
0.018

0.016

0.014

0.012
RMI(SE)

0.01 OC

0.008

0.006
Your RMI
0.004

0.002
Bias
0
SD
-20 -15 -10 -5 0 5 10 15 20
Systematic Error(SE)
Expected # QC Events to Detection, E(QCE)

9000

8000 100

% Unreliable Results
7000
80
6000

5000
60
4000

3000 40

2000
20
1000

0 0
-20 -15 -10 -5 0 5 10 15 20
Systematic Error(SE)
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07/09/2018 Analytical Risk Assessment
MERCHANTABILITY, OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED, IS MADE CONCERNING THE DATA OR INFORMATION PROVIDED HEREIN. IN NO EVENT SHALL BIO-RAD BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES, LOSS OF PROFITS, SPECIAL OR INDIRECT DAMAGES.

©2018 Bio-Rad Laboratories, Inc. Printed: Friday, September 7, 2018, 8:00:20 PM

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