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Quality Control Report: Uric Acid & Glucose

This document summarizes the results of quality control tests for uric acid conducted from March 1-30. It shows the test name, reagents, method, instrument, mean values, standard deviations and control limits calculated over 30 days. Charts are also included plotting the daily values and mean over time to monitor the quality control testing.

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0% found this document useful (0 votes)
4 views11 pages

Quality Control Report: Uric Acid & Glucose

This document summarizes the results of quality control tests for uric acid conducted from March 1-30. It shows the test name, reagents, method, instrument, mean values, standard deviations and control limits calculated over 30 days. Charts are also included plotting the daily values and mean over time to monitor the quality control testing.

Uploaded by

Richa
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd

QUALITY CONTROL INTERN

TEST NAME URIC ACID BIORAD Level.....


REAGENT MULTIGENT ABBOT NO. LOT 14171
METHOD GOD PAP Mean SD CV

INSTRUMENT ARCHITECT ci8200 1.88 0.05 2.72

NO Nilai Kontrol (Periode Pendahuluan) Nilai Kontrol Nilai dari Peri


Running creatinin creatinin Mean SD LCL 1 SD
1 1-Mar-17 1.80 1.81 1.88 0.05 1.83
2 2-Mar-17 1.84 1.84 1.88 0.05 1.83
3 3-Mar-17 1.80 1.80 1.88 0.05 1.83
4 4-Mar-17 1.95 1.95 1.88 0.05 1.83
5 5-Mar-17 1.90 1.90 1.88 0.05 1.83
6 6-Mar-17 1.91 1.91 1.88 0.05 1.83
7 7-Mar-17 1.94 1.94 1.88 0.05 1.83
8 8-Mar-17 1.81 1.81 1.88 0.05 1.83
9 9-Mar-17 1.84 1.84 1.88 0.05 1.83
10 10-Mar-17 1.88 1.88 1.88 0.05 1.83
11 11-Mar-17 1.92 1.92 1.88 0.05 1.83
12 12-Mar-17 1.87 1.87 1.88 0.05 1.83
13 13-Mar-17 1.83 1.86 1.88 0.05 1.83
14 14-Mar-17 1.93 1.87 1.88 0.05 1.83
15 15-Mar-17 1.98 1.85 1.88 0.05 1.83
16 16-Mar-17 1.92 1.78 1.88 0.05 1.83
17 17-Mar-17 1.86 1.98 1.88 0.05 1.83
18 18-Mar-17 1.90 1.87 1.88 0.05 1.83
19 19-Mar-17 1.96 1.85 1.88 0.05 1.83
20 20-Mar-17 1.88 1.86 1.88 0.05 1.83
21 21-Mar-17 1.92 1.79 1.88 0.05 1.83
22 22-Mar-17 1.89 1.89 1.88 0.05 1.83
23 23-Mar-17 1.85 1.85 1.88 0.05 1.83
24 24-Mar-17 1.83 1.80 1.88 0.05 1.83
25 25-Mar-17 1.81 1.81 1.88 0.05 1.83
26 26-Mar-17 1.88 1.88 1.88 0.05 1.83
27 27-Mar-17 1.86 1.82 1.88 0.05 1.83
28 28-Mar-17 1.90 1.82 1.88 0.05 1.83
29 29-Mar-17 1.83 1.80 1.88 0.05 1.83
30 30-Mar-17 1.80 1.81 1.88 0.05 1.83

Mean 1.88
SD 0.05 155.00 Grafik Kontrol Gluko
CV 2.72 145.00
Nilai Glukosa (mg/dL)

-1SD 1.83 135.00


125.00
+1SD 1.93
115.00
-2SD 1.77
105.00
+2SD 1.77
95.00
-3SD 1.72 85.00
+3SD 2.03 75.00
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Gl ukos a Mean
Hari Ke-
+2 SD -2 SD
75.00
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Gl ukos a Mean
Hari Ke-
+2 SD -2 SD
INTERNAL

UNIT mg/dL

TEa ................

Nilai dari Periode Pendahuluan


UCL 1 SD LCL 2 SD UCL 2 SD LCL 3 SD UCL 3 SD
1.93 1.77 1.77 1.72 2.03 89

1.93 1.77 1.77 1.72 2.03 87


1.93 1.77 1.77 1.72 2.03 88

1.93 1.77 1.77 1.72 2.03 91


1.93 1.77 1.77 1.72 2.03 85

1.93 1.77 1.77 1.72 2.03 86

1.93 1.77 1.77 1.72 2.03 90


1.93 1.77 1.77 1.72 2.03 84

1.93 1.77 1.77 1.72 2.03 83

1.93 1.77 1.77 1.72 2.03 84


1.93 1.77 1.77 1.72 2.03 87

1.93 1.77 1.77 1.72 2.03 86

1.93 1.77 1.77 1.72 2.03 86


1.93 1.77 1.77 1.72 2.03 87
1.93 1.77 1.77 1.72 2.03 87
1.93 1.77 1.77 1.72 2.03 85
1.93 1.77 1.77 1.72 2.03 86
1.93 1.77 1.77 1.72 2.03 85
1.93 1.77 1.77 1.72 2.03 87
1.93 1.77 1.77 1.72 2.03 86
1.93 1.77 1.77 1.72 2.03 88
1.93 1.77 1.77 1.72 2.03 83
1.93 1.77 1.77 1.72 2.03 91
1.93 1.77 1.77 1.72 2.03 86
1.93 1.77 1.77 1.72 2.03 88
1.93 1.77 1.77 1.72 2.03 84
1.93 1.77 1.77 1.72 2.03 87
1.93 1.77 1.77 1.72 2.03 88
1.93 1.77 1.77 1.72 2.03 91
1.93 1.77 1.77 1.72 2.03 86

afik Kontrol Glukosa

1 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Mean
Hari Ke- +1 SD -1 SD
-2 SD +3 SD -3 SD
1 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Mean
Hari Ke- +1 SD -1 SD
-2 SD +3 SD -3 SD
155.00
Grafik Kontrol Glukosa
145.00
Nilai Glukosa (mg/dL)

135.00
125.00
115.00
105.00
95.00
85.00
75.00
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Hari Ke-
Gl ukos s a Mean +1 SD -1 SD
+2 SD -2 SD +3 SD -3 SD

Interpretasi Grafik :
* Berdasarkan aturan Wesgard Control
data
pada kontrol Glukosa yang
dibuat selama bulan April, didapatkan
Hasil" Kurang Terkendali "
1. R4S pada hari ke-26 s.d ke-29 No
In – control
(Hasil tidak boleh dikeluarkan) 12s Report results
2. 41S pada hari ke-7 s.d ke-10
(Hasil tidak boleh dikeluarkan)
Yes

No No No No
13s 22s R4s 41s

Yes Yes Yes Yes

Out-of-control, reject analytical run


No

24 25 26 27 28 29 30

Yes

No

rol
sults

N
o Yes Yes
No
101s

Yes Yes

run
No

Yes Yes

30
PENGENDALIAN MUTU INTERNAL
PERIODE: Mei 2016

TEST NAME CHOLESTEROL BIORAD Level 1 BIORAD Leve


REAGENT MULTIGENT ABBOT NO. LOT 14171 NO. LOT 1417
METHOD CHOD PAP -3S MEAN +3S -3S
INSTRUMENT ARCHITECT ci8200 Err:509

Target Value 98.30 282.00


Bias / (%) Err:509 Err:509 Err:509
CONTROL LIMIT
SD / CV Err:509 Err:509
Sigma Err:509 Err:509
QC RULE Err:509

NO TGL LV 1 LV 2 Flag
SD
-4.00 -3.00 -2.00 -1.00 0.00 1.00
1 101 284 Err:509 0
2 100 291 Err:509

3 102 287 Err:509

4 100 281 Err:509


1
5 100 286 Err:509

6 100 286 Err:509

7 100 286 Err:509


2
8 102 287 Err:509

9 102 289 Err:509

10 100 287 Err:509

11 102 290 Err:509 3

12 101 284 Err:509

13 101 289 Err:509

14 98 287 Err:509 4
15 97 282 Err:509

16 99 286 Err:509

17 98 282 Err:509
5
18 99 284 Err:509

19 102 282 Err:509

20 102 281 Err:509


6
21 100 283 Err:509

22 98 294 Err:509

23 99 279 Err:509

24 101 291 Err:509 7


Err:509

Err:509

Err:509
8
Err:509

Err:509

Err:509
9

MEAN 100.17 285.75

SD 1.49 3.72

CV % 1.49% 1.30% 10

Bias 1.87 3.75


Bias (%) 1.90% 1.33%
11
% TE 0.05 0.04 11
Sigma 5.43 6.66
ERNAL
BIORAD Level 2
NO. LOT 14172
MEAN +3S TEa 10.0%
Err:509 TE (Lev 1) #VALUE!

282.00 TE (Lev 2) #VALUE!


Err:509
UNIT mg/dL

Err:509

SD
1.00 0.00 1.00 2.00 3.00 4.00

level 1 level2

Common questions

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External and internal quality controls complement each other in clinical test accuracy by providing a comprehensive check on the system. Internal controls ensure consistent performance and immediate error detection within a laboratory's daily operations, while external controls offer an objective benchmark against other laboratories and testing standards. Together, they assure stakeholders of result accuracy and consistency, fostering trust in laboratory diagnostics while facilitating regulatory compliance and accreditation .

The coefficient of variation (CV) is crucial in assessing test method performance as it provides a normalized measure of dispersion of the data relative to the mean. A lower CV suggests high precision with consistent results, while a higher CV indicates greater variability and potential inaccuracy. In the context of uric acid testing, a CV of 2.72 indicates a reasonably consistent performance, suggesting that the assay maintains a stable variability under control conditions, which is critical for reliable clinical interpretations .

Bias impacts the quality control process in cholesterol testing by indicating the deviation of measured results from the true value. A bias of 1.87 for Level 1 and 3.75 for Level 2, expressed as percentages (1.90% and 1.33%, respectively), shows that although the deviation is small, it is essential to monitor and adjust for accurately reflecting patient data. Minimizing bias is critical to ensure that test results are as accurate as possible, especially for diagnostic decisions .

Having Level 1 and Level 2 controls in cholesterol testing is crucial to assessing assay performance at multiple concentration levels, which ensures more comprehensive quality control. The mean values for Level 1 and Level 2 are 100.17 and 285.75, respectively, with standard deviations of 1.49 and 3.72. These values indicate a consistent performance in the assay, reflected in low variability at different concentration levels, thus enhancing the reliability of cholesterol measurements across a range of clinically relevant levels .

The application of Westgard rules affects the interpretation of glucose control charts by identifying specific days when the control limits are breached. For instance, the document indicates that during April, the results from days 7 to 10 and days 26 to 29 were considered 'Out of control' as per the Westgard rules, including R4S and 41S, requiring rejection of the analytical run. This application indicates a lack of stability in the process during these periods and necessitates corrective actions .

Different sigma levels impact decision-making in clinical laboratories by providing a metric for process capability and precision. Higher sigma levels indicate fewer defects and higher process quality. For example, the sigma levels of 5.43 and 6.66 in cholesterol testing reflect strong process capability with fewer chances of error, implying reliable test outcomes. Decision-making based on sigma levels helps prioritize improvement efforts and establish tolerance limits, essential for maintaining high standards in clinical diagnosis .

Graphical control tools, such as control charts, can be effectively used to monitor glucose testing accuracy by visualizing data trends, variability, and any deviations from normative performance standards over time. By plotting daily glucose levels with mean and SD limits, laboratories can detect trends or shifts indicating issues like procedural errors or equipment malfunction early. This proactive monitoring allows labs to maintain adherence to quality standards, ensuring result accuracy for patient safety .

The statistical indicators that suggest the uric acid testing process is well calibrated include a mean value of 1.88, a standard deviation (SD) of 0.05, and a coefficient of variation (CV) of 2.72. These values indicate a stable and precise testing process, as the SD is low, suggesting minimal variation in repeat measurements, and the CV is within an acceptable range for biological assays .

Reporting 'Out-of-control' analytical runs is crucial as it ensures the integrity of the laboratory's test results. It helps to identify systematic errors or deviations from expected performance, which can be detrimental to the validity of patient test outcomes. Identifying these runs allows for timely corrective actions and recalibration, maintaining the reliability and accuracy of the laboratory testing process .

Ignoring control chart indicators, like Westgard rules, in laboratory testing can lead to serious consequences including inaccurate results, misdiagnosis, and inappropriate treatment plans. Failure to identify and correct 'Out-of-control' situations may result in the propagation of systematic errors across test results. This neglect can compromise patient safety and erode confidence in laboratory results, making adherence to these indicators crucial to maintaining diagnostic accuracy and laboratory quality standards .

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