scholarly journals Internal quality control: planning and implementation strategies

2003 ◽  
Vol 40 (6) ◽  
pp. 593-611 ◽  
Author(s):  
James O Westgard
Keyword(s):  
Quality Control ◽  
Error Detection ◽  
Planning Process ◽  
Clinical Laboratory ◽  
Test Procedure ◽  
Implementation Strategies ◽  
Internal Quality Control ◽  
Internal Quality ◽  
General Strategy ◽  
The Right

The first essential in setting up internal quality control (IQC) of a test procedure in the clinical laboratory is to select the proper IQC procedure to implement, i.e. choosing the statistical criteria or control rules, and the number of control measurements, according to the quality required for the test and the observed performance of the method. Then the right IQC procedure must be properly implemented. This review focuses on strategies for planning and implementing IQC procedures in order to improve the quality of the IQC. A quantitative planning process is described that can be implemented with graphical tools such as power function or critical-error graphs and charts of operating specifications. Finally, a total QC strategy is formulated to minimize cost and maximize quality. A general strategy for IQC implementation is recommended that employs a three-stage design in which the first stage provides high error detection, the second stage low false rejection and the third stage prescribes the length of the analytical run, making use of an algorithm involving the average of normal patients' data.

Alternative method evaluation of internal quality control in the Clinical Laboratory of Pontifical Catholic University of Goiás

2018 ◽  
Vol 50 (1) ◽  
Author(s):  
Fernando de Almeida Dias ◽  
Kassya Lopes Epaminondas Martins ◽  
Sérgio Henrique Nascente Costa
Keyword(s):  
Quality Control ◽  
Clinical Laboratory ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Method Evaluation ◽  
Catholic University ◽  
Alternative Method

Internal Quality Control of PCR-based Genotyping Methods in Research Studies and Patient Diagnostics

2002 ◽  
Vol 87 (05) ◽  
pp. 812-816 ◽  
Author(s):  
Jørgen Gram ◽  
Jørgen Jespersen ◽  
Moniek de Maat ◽  
Else-Marie Bladbjerg
Keyword(s):  
Quality Control ◽  
Clinical Laboratory ◽  
Dna Amplification ◽  
Restriction Enzymes ◽  
Control Programme ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Reagent Blank ◽  
Thrombosis Research ◽  
Control Programmes

SummaryGenetic analyses are increasingly integrated in the clinical laboratory, and internal quality control programmes are needed. We have focused on quality control aspects of selected polymorphism analyses used in thrombosis research. DNA was isolated from EDTA-blood (n = 500) by ammonium acetate precipitation and analysed for 18 polymorphisms by polymerase chain reaction (PCR), i. e. restriction fragment length polymorphisms, allele specific amplification, or amplification of insertion/deletion fragments. We evaluated the following aspects in the analytical procedures: sample handling and DNA-isolation (pre-analytical factors), DNA-amplification, digestion with restriction enzymes, electrophoresis (analytical factors), result reading and entry into a database (post-analytical factors). Furthermore, we evaluated a procedure for result confirmation. Isolated DNA was of good quality (42 µ.g/ml blood, A260/A280 ratio >1.75, negative DNAsis tests), and the reagent blank was contaminated in <1% of the results. Occasionally, results were re-analysed because of positive reagent blanks (<1%) or because of problems with the controls (< 5%). On confirmation, we observed 4 genotyping discrepancies. Control of data handling revealed 0.1% reading mistakes and 0.5% entry mistakes. Based on our experiences we propose an internal quality control programme for widely used PCR-based haemostasis polymorphism analyses.

Internal quality control: best practice

2013 ◽  
Vol 66 (12) ◽  
pp. 1027-1032 ◽  
Author(s):  
Helen Kinns ◽  
Sarah Pitkin ◽  
David Housley ◽  
Danielle B Freedman
Keyword(s):  
Quality Control ◽  
Error Detection ◽  
Best Practice ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Assay Performance ◽  
Clinically Significant ◽  
Clinical Biochemistry Laboratory ◽  
Definition Of ◽  
Selection Of

There is a wide variation in laboratory practice with regard to implementation and review of internal quality control (IQC). A poor approach can lead to a spectrum of scenarios from validation of incorrect patient results to over investigation of falsely rejected analytical runs. This article will provide a practical approach for the routine clinical biochemistry laboratory to introduce an efficient quality control system that will optimise error detection and reduce the rate of false rejection. Each stage of the IQC system is considered, from selection of IQC material to selection of IQC rules, and finally the appropriate action to follow when a rejection signal has been obtained. The main objective of IQC is to ensure day-to-day consistency of an analytical process and thus help to determine whether patient results are reliable enough to be released. The required quality and assay performance varies between analytes as does the definition of a clinically significant error. Unfortunately many laboratories currently decide what is clinically significant at the troubleshooting stage. Assay-specific IQC systems will reduce the number of inappropriate sample-run rejections compared with the blanket use of one IQC rule. In practice, only three or four different IQC rules are required for the whole of the routine biochemistry repertoire as assays are assigned into groups based on performance. The tools to categorise performance and assign IQC rules based on that performance are presented. Although significant investment of time and education is required prior to implementation, laboratories have shown that such systems achieve considerable reductions in cost and labour.

Performance characteristics of rules for internal quality control: probabilities for false rejection and error detection.

1977 ◽  
Vol 23 (10) ◽  
pp. 1857-1867 ◽  
Author(s):  
J O Westgard ◽  
T Groth ◽  
T Aronsson ◽  
H Falk ◽  
C H de Verdier
Keyword(s):  
Quality Control ◽  
Error Detection ◽  
Control Charts ◽  
Performance Characteristics ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Sum Rule ◽  
Control Rules ◽  
Systematic Shift ◽  
False Rejection

Abstract When assessing the performance of an internal quality control system, it is useful to determine the probability for false rejections (pfr) and the probability for error detection (ped). These performance characteristics are estimated here by use of a computer stimulation procedure. The control rules studied include those commonly employed with Shewhart-type control charts, a cumulative sum rule, and rules applicable when a series of control measurements are treated as a single control observation. The error situations studied include an increase in random error, a systematic shift, a systematic drift, and mixtures of these. The probability for error detection is very dependent on the number of control observations and the choice of control rules. No one rule is best for detecting all errors, thus combinations of rules are desirable. Some appropriate combinations are suggested and their performance characteristics are presented.

scholarly journals The application of Student’s t -test in internal quality control of clinical laboratory

2017 ◽  
Vol 1 (3) ◽  
pp. 125-128 ◽  
Author(s):  
Yang-chun Feng ◽  
Yan-chun Huang ◽  
Xiu-min Ma
Keyword(s):  
Quality Control ◽  
Clinical Laboratory ◽  
T Test ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Student’S T ◽  
Student’S T Test

Internal quality control samples for water bacteriology

1994 ◽  
Vol 76 (3) ◽  
pp. 270-274 ◽  
Author(s):  
R.J. Lee ◽  
S.R. Cole
Keyword(s):  
Quality Control ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Control Samples

scholarly journals Shortcomings Require Internal Quality Control

2004 ◽  
Vol 22 (1) ◽  
pp. 72
Author(s):  
BR Mirdha
Keyword(s):  
Quality Control ◽  
Internal Quality Control ◽  
Internal Quality
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