" Exactitud en Tiempo Real"

“Just Accurate Results”

PROGRAMA DE EVALUACION EXTERNA DE LA CALIDAD

QC PROCESS ®

LABORATORIO NOMBRE DEL LAB FOR-QCP-003

VERSION 4.0

FECHA MES Y AÑO Nov-10

DEPARTAMENTO NOMBRE DEL DEPTO

RESPONSABLE NOMBRE DEL RESPONSABLE

E-MAIL CORREO ELECTRONICO

DOMICILIO

TELEFONO

ELABORO APROBO
FECHA DE IMPRESION
ING. JUAN ANTONIO ROSALES 07/17/2023 DR. ARTURO M TERRES S
DIRECTOR DE OPERACION DIRECTOR GENERAL
12 1 0 12 2 A 12 3
11 11 11
10 A 10 10
9 9 N 9
8 8 8
7 N 7 7 A
6 6 B 6
5 y = mx + b 5 y = mx + b 5 y = mx + b
4 B m = 1.0 4 m = 1.0 4 N m = 1.0
3 b = 0.0 3 b = 3.0 3 b = -2.0
2 r = 1.0 2 r = 1.0 2 r = 1.0
1 1 1 B
1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12

1 VE VO 2 VE VO 3 VE VO
A 9 9 A 9 12 A 9 7
N 6 6 N 6 9 N 6 4
B 3 3 B 3 6 B 3 1
X Y X Y X Y

12 4 12 5 A 12 6
11 11 11 y = mx + b
10 10 10 m = 0.83
9 A 9 N 9 b = -1.67
8 N 8 8 r = 0.99
7 7 7
6 6 6 A
5 y = mx + b 5 B y = mx + b 5
4 m = 1.17 4 m = 1.17 4
3 b = -0.67 3 b = 1.67 3 N
2 B r = 0.85 2 r = 0.99 2
1 1 1 B
1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12

4 VE VO 5 VE VO 6 VE VO
A 9 9 A 9 12 A 9 6
N 6 8 N 6 9 N 6 3
B 3 2 B 3 5 B 3 1
X Y X Y X Y

12 7 12 8 12 9
11 A 11 11 y = mx + b
10 10 10 m = 1.17
9 9 A 9 b = -1.67 A
8 8 N 8 r = 0.99
7 7 7
6 B N 6 6
5 y = mx + b 5 B y = mx + b 5 N
4 m = 0.83 4 m = 1.00 4
3 b = 2.67 3 b = 2.00 3
2 r = 0.75 2 r = 1.00 2 B
1 1 1
1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12

7 VE VO 8 VE VO 9 VE VO
A 9 11 A 9 11 A 9 9
N 6 6 N 6 8 N 6 5
B 3 6 B 3 5 B 3 2
X Y X Y X Y

12 10 12 11 12 12 A
11 11 11
10 10 10
9 N 9 9
8 A 8 8
7 7 A 7 N
6 6 6
5 y = mx + b 5 B N y = mx + b 5 y = mx + b
4 m = 0.67 4 m = 0.50 4 m = 1.83
3 B b = 2.33 3 b = 2.67 3 b = -4.67
2 r = 0.43 2 r = 0.96 2 r = 1.00
1 1 1 B
1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12

10 VE VO 11 VE VO 12 VE VO
A 9 7 A 9 7 A 9 12
N 6 9 N 6 6 N 6 6
B 3 3 B 3 4 B 3 1
X Y X Y X Y
 QC PROCESS
EVALUACION DE LA EXACTITUD

PRUEBA MIN MAX UNIDADES

RANGO ANALITICO TP 5.0 30.0 SEG PRECISION CVR 1.07
CONCLUSION
EXACTITUD BIAS 12.5%
RESULTADOS DELTA BIAS RECOMENDACIÓN RECALIBRAR TRES PUNTOS PARA CORREGIR BIAS %
CICLO LABORATORIO V. ASIGNADO SEG %
38 25.7 22.2 -3.5 14% BIAS %
39 11.4 10.8 -0.6 5%
18%
40 25.2 21.3 -3.9 15%
41 11.5 10.7 -0.8 7% 16%
42 27.6 22.9 -4.7 17%
43 27.3 23.5 -3.8 14% 14%
44 12.1 11.0 -1.1 9%
12%
45 26.5 24.0 -2.5 9%
46 11.1 10.7 -0.4 3% 10%
47 27.4 23.2 -4.2 15%
48 12.3 10.7 -1.6 13% 8%
49 12.3 10.7 -1.6 13%
6%

MAX 27.6 24.0 -3.6 13% 4%

MEDIA 19.2 16.8 -2.4 12.5%
MIN 11.1 10.7 -0.4 3% 2%

0%
RANGO 16.5 13.3 -3.2
1 2 3 4 5 6 7 8 9 10 11 12
DS 7.8 6.3 -1.4
CV 40.5% 37.7% -2.8%
ESPERADO OBSERVADO
CVR 1.07 CV RELATIVO : LAB / GPO.CONTROL
40.0
CEF. CORR ( R2) 1.00
PENDIENTE (M) 1.24 35.0
INTERSECCION (B) -2.00
DELTA BIAS 30.0
ESPERADO OBSERVADO SEG %
Y = MX + B 5.0 4.2 0.8 -15.9% 25.0
2.77777777777778 7.8 7.6 0.1 -1.7%
10.6 11.1 -0.5 5.1%
20.0
13.3 14.5 -1.2 9.0%
16.1 18.0 -1.9 11.6%
15.0
18.9 21.4 -2.5 13.4%
21.7 24.9 -3.2 14.8%
24.4 28.3 -3.9 15.8% 10.0
27.2 31.8 -4.5 16.7%
30.0 35.2 -5.2 17.3% 5.0

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 QC PROCESS
EVALUACION DE LA EXACTITUD

PRUEBA MIN MAX UNIDADES

RANGO ANALITICO LEUCOCITOS 1.0 50.0 mil/uL PRECISION CVR 1.36
CONCLUSION
EXACTITUD BIAS -16.4%
RESULTADOS DELTA BIAS RECOMENDACIÓN RECALIBRAR TRES PUNTOS PARA CORREGIR BIAS %
CICLO LABORATORIO V. ASIGNADO mil/uL %
1 18.4 20.1 1.8 -10% BIAS %
2 12.9 16.9 4.0 -31%
40%
3 3.8 6.8 3.0 -79%
4 26.3 20.1 -6.2 24%
5 13.6 16.8 3.2 -24% 20%
6 2.5 3.4 0.9 -36%
7 16.2 20.1 3.9 -24% 0%
8 12.4 16.6 4.2 -34% 1 2 3 4 5 6 7 8 9 10 11 12
9 2.5 3.4 0.9 -35%
-20%
10 18.1 17.0 -1.1 6%
11 3.8 6.8 3.0 -80%
12 2.3 3.3 1.0 -42% -40%

MAX 26.3 20.1 -6.2 24% -60%

MEDIA 10.8 12.6 1.8 -16.4%
MIN 2.3 3.3 1.0 -42% -80%

RANGO 24.0 16.8 -7.2

-100%
DS 8.3 7.2 -1.2
CV 77.0% 56.8% -20.2%
ESPERADO OBSERVADO
CVR 1.36 CV RELATIVO : LAB / GPO.CONTROL
80.0
CEF. CORR ( R2) 0.95
PENDIENTE (M) 1.41 70.0
INTERSECCION (B) -3.72
DELTA BIAS 60.0
ESPERADO OBSERVADO mil/uL %
Y = MX + B 1.0 -2.3 3.3 -331.5% 50.0
5.44444444444444 6.4 5.3 1.1 -17.2%
11.9 13.0 -1.1 9.3% 40.0
17.3 20.6 -3.3 19.1%
22.8 28.3 -5.5 24.3% 30.0
28.2 36.0 -7.7 27.4%
33.7 43.6 -9.9 29.5% 20.0
39.1 51.3 -12.2 31.1%
44.6 58.9 -14.4 32.2% 10.0
50.0 66.6 -16.6 33.1%
0.0
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 QC PROCESS
EVALUACION DE LA EXACTITUD

PRUEBA MIN MAX UNIDADES

RANGO ANALITICO PRECISION CVR #DIV/0!
CONCLUSION
EXACTITUD BIAS #DIV/0!
RESULTADOS DELTA BIAS RECOMENDACIÓN RECALIBRAR TRES PUNTOS PARA CORREGIR BIAS %
CICLO LABORATORIO V. ASIGNADO 0 %
0.0 #DIV/0! BIAS %
0.0 #DIV/0!
1200%
0.0 #DIV/0!
0.0 #DIV/0!
0.0 #DIV/0! 1000%
0.0 #DIV/0!
0.0 #DIV/0!
800%
0.0 #DIV/0!
0.0 #DIV/0!
0.0 #DIV/0! 600%
0.0 #DIV/0!
0.0 #DIV/0!
400%

MAX 0.0 0.0 0.0 #DIV/0!

MEDIA #DIV/0! #DIV/0! #DIV/0! #DIV/0! 200%
MIN 0.0 0.0 0.0 #DIV/0!
0%
RANGO 0.0 0.0 0.0
1 2 3 4 5 6 7 8 9 10 11 12
DS #DIV/0! #DIV/0! #DIV/0!
CV #DIV/0! #DIV/0! #DIV/0!
ESPERADO OBSERVADO
CVR #DIV/0! CV RELATIVO : LAB / GPO.CONTROL
1.0
CEF. CORR ( R2) #DIV/0!
0.9
PENDIENTE (M) #DIV/0!
INTERSECCION (B) #DIV/0! 0.8
DELTA BIAS
ESPERADO OBSERVADO 0 % 0.7
Y = MX + B 0.0 #DIV/0! #DIV/0! #DIV/0!
0 0.0 #DIV/0! #DIV/0! #DIV/0! 0.6
0.0 #DIV/0! #DIV/0! #DIV/0!
0.5
0.0 #DIV/0! #DIV/0! #DIV/0!
0.0 #DIV/0! #DIV/0! #DIV/0! 0.4
0.0 #DIV/0! #DIV/0! #DIV/0!
0.0 #DIV/0! #DIV/0! #DIV/0! 0.3
0.0 #DIV/0! #DIV/0! #DIV/0!
0.0 #DIV/0! #DIV/0! #DIV/0! 0.2

0.0 #DIV/0! #DIV/0! #DIV/0!

0.1

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