Applying The Best Practice For Internal Quality Control (IQC) Management, Consolidation And Review Process In Sidra Medicine Clinical Chemistry Division

2020 ◽  
Vol 154 (Supplement_1) ◽  
pp. S91-S91
Author(s):  
J M Asinas
Keyword(s):  
Quality Control ◽  
Real Time ◽  
Best Practice ◽  
Clinical Chemistry ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Allowable Error ◽  
Chemistry Division ◽  
Set Up ◽  
High Level

Abstract Introduction/Objective The management of internal quality control (IQC) in Sidra Medicine Clinical Chemistry Division has been evaluated in order to promote a more consolidated and efficient process of IQC management. The statistical data produced from Cerner QC Module are transferred to IQC review templates consisting of formulas to auto- calculate parameters such as multiple of expected QC failure frequency and desirable comparison limit between analyzers. The IQC review and documentation process using the in-house excel template requires several hours to complete, hence a faster and more efficient IQC management module is required. The main objective of this study is to improve the initial IQC management set up, work flow and review procedures and to implement Biorad Unity Real Time (URT) program to develop a more efficient IQC management system. Methods The URT software has been recently configured and implemented to consolidate and streamline IQC management. URT is built through Sidra Medicine IT Enterprise level which allows multiple users to login. IQC data are downloaded using scripts from Cerner which are filtered through Biorad Unity Connect (UC) software. Additional quality tools are also explored such as various user defined statistical reports, IQC analysis using peer reviewed total allowable error (TeA) and assignment of the most appropriate Westgard rules. Determination of sigma metrics and uncertainty of measurement is also performed using the URT application. Results The generation of any IQC report is less cumbersome and time consuming as compared with the previous process. However, some user defined formulas in the IQC templates are not found on the URT reports. The URT Levey Jennings chart are also more user friendly and directly compares the daily IQC data with Unity inter-laboratory peers enabling the production of instant and monthly reports through QCNet site when assay investigation is required and for IQC report documentation. Conclusion The combination of Cerner IQC, Unity Real-time, QCNet Inter-laboratory reports and in house IQC templates produce a high level and very detailed IQC review which effectively evaluate assay performance to assist on IQC troubleshooting and root cause analysis to be able to apply the most appropriate corrective actions.

Quality control as a fundamental institute of medical activities (review of literary sources)

2021 ◽  
pp. 39-48
Author(s):  
Larisa Arkadyevna Karaseva ◽  
Tatyana Vladimirovna Bessonova
Keyword(s):  
Quality Of Life ◽  
Quality Control ◽  
Medical Care ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Quality And Safety ◽  
Professional Activities ◽  
Literary Sources ◽  
High Level

The aim of the study, analyze and evaluate the quality control and safety of medical activities carried out in medical organizations. Results: the essence of the concept of quality control in the field of medical care was determined, criteria for assessing the quality of medical activities were identified, the main aspects of developing a program for internal quality control and safety of medical activities were characterized, key risks existing in medical activities were identified, directions for improving the quality and safety of professional activities of medical workers. Conclusion: modern approaches to the organization of quality control and safety of medical activities make it possible to ensure a high level of medical care provided to the population and improve the quality of life of the population as a whole.

scholarly journals PENGGUNAAN BAHAN ACUAN BERSERTIFIKAT OYSTER TISSUE 1566b SEBAGAI INTERNAL QUALITY CONTROL UNTUK MENENTUKAN KADAR TIMBAL TOTAL DALAM TEPUNG IKAN MARLIN DENGAN ELECTROTHERMAL ATOMIC ABSORPTION SPECTROMETRY

2015 ◽  
Vol 17 (2) ◽  
pp. 131-137
Author(s):  
Willy Cahya Nugraha ◽  
Yohanes Susanto Ridwan
Keyword(s):  
Quality Control ◽  
Reference Materials ◽  
Certified Reference Materials ◽  
Electrothermal Atomic Absorption Spectrometry ◽  
Absorption Spectrometry ◽  
Lead Content ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Oyster Tissue ◽  
High Level

Lead is widely knows as one of the harmful pollutants for humans. Contaminated fishery built by lead may endanger the consumption body. Therefore, contamination monitoring for the fishery products is necessary to be conducted. To ensure the validity of data, Oyster Tissue 1566b certified reference material was used as Internal Quality Control. Marlin fish powder and certified reference materials were analyzed with the same method, personnel, duration or time, equipment and environmental conditions. As the results, it was found that the lead contained in CRM was 0.306 mg.kg-1 with 11.9 % rsd, which is within range of lead content in  the certificate. The method was applied for Marlin Fish. Lead content obtained in this study (1.821 mg.kg-1 with 11.06 % rsd) can be reported with high level of confidence.Keywords: Lead, Certified Reference Materials, Marlin fish

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.

Evaluation of Quality Control in Clinical Chemistry and Hematology Using Sigma Metrics

2019 ◽  
Vol 152 (Supplement_1) ◽  
pp. S80-S80
Author(s):  
Carol Njeru
Keyword(s):  
Quality Control ◽  
Blood Cell ◽  
Cell Count ◽  
Clinical Chemistry ◽  
Hematological Parameters ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Total Serum ◽  
Blood Cell Count ◽  
Method Performance

Abstract Objectives The aim of this study was to evaluate clinical chemistry and hematology laboratory performance using six sigma metrics. Methods Clinical chemistry data and hematology data were analyzed from Bungoma Referral Hospital. Five parameters from renal and liver function tests were studied over a period of 6 months (December 2016 to May 2017). Data from IQC and EQA participation were used. The analytes were plasma creatinine, aspartate transaminase (AST), alanine transaminase (ALT), total serum protein, and total and direct bilirubin. Hematology parameters, namely white blood cell count (WBC), red blood cell count (RBC), and hemoglobin (Hb) levels, were studied. Data from IQC and EQA participation were used. Sigma metrics was calculated using total allowable error as per CLIA recommendations. Bias was calculated from HUQAS EQA participation while coefficient of variation was calculated from IQC data collected during the abovementioned months. Results Clinical chemistry had sigma metrics below 3; the highest sigma value was 2.01 while the lowest sigma value was 0.85. Hematological parameters had sigma levels above 3. The highest sigma value was 7.21 while the lowest sigma value was 3.87. Only one level of sigma was below 4. Conclusion Clinical chemistry analytes had sigma levels less than 3; method performance improvement with stringent internal quality control and correct setting of control limits need to be applied. Application of sigma metrics in addition to daily internal quality control can identify analytical deficits and improvement in clinical laboratories. Most hematological parameters had sigma levels above 3. The highest sigma value was 7.21 while the lowest sigma value was 3.87. Only one level of sigma was below 4.

scholarly journals The Evaluation of Analytical Performance of Immunoassay Tests by Using Six-Sigma Method

2017 ◽  
Vol 36 (4) ◽  
pp. 301-308 ◽  
Author(s):  
Rukiye Nar ◽  
Dilek Iren Emekli
Keyword(s):  
Quality Control ◽  
Six Sigma ◽  
Clinical Chemistry ◽  
Quality Measurement ◽  
Analytical Performance ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Variation Database ◽  
The Mean ◽  
Six Sigma Methodology

SummaryBackground: The Six-Sigma Methodology is a quality measurement method in order to evaluate the performance of the laboratory. In the present study, it is aimed to evaluate the analytical performance of our laboratory by using the internal quality control data of immunoassay tests and by calculating process sigma values. Methods: Biological variation database (BVD) are used for Total Allowable Error (TEa). Sigma values were determined from coefficient of variation (CV) and bias resulting from Internal Quality Control (IQC) results for 3 subsequent months. If the sigma values are ≥6, between 3 and 6, and <3, they are classified as »world-class«, »good« or »un - acceptable«, respectively. Results: A sigma value >6 was found for TPSA and TSH for the both levels of IQC for 3 months. When the sigma values were analyzed by calculating the mean of 3 months, folate, LH, PRL, TPSA, TSH and vitamin B12 were found >6. The mean sigma values of CA125, CA15-3, CA19-9, CEA, cortisol, ferritin, FSH, FT3, PTH and testosteron were >3 for 3-months. However, AFP, CA125 and FT4 produced sigma values <3 for varied months. Conclusion: When the analytical performance was evaluated according to Six-Sigma levels, it was generally found as good. It is possible to determine the test with high error probability by evaluating the fine sigma levels and the tests that must be quarded by a stringent quality control regime. In clinical chemistry laboratories, an appropriate quality control scheduling should be done for each test by using Six-Sigma Methodology.

scholarly journals Assessment of sigma metrics results of serum glucose and lipid profile tested by automated chemistry analyzer in medical city hospitals in Iraq

2017 ◽  
Vol 5 (11) ◽  
pp. 4690
Author(s):  
Ahmed Naseer Kaftan ◽  
Anne Khazal Yaseen ◽  
Zina Hasan
Keyword(s):  
Quality Control ◽  
Lipid Profile ◽  
Six Sigma ◽  
Clinical Chemistry ◽  
Serum Glucose ◽  
Error Rates ◽  
Internal Quality ◽  
Total Allowable Error ◽  
Medical City ◽  
Allowable Error

Background: A major target of quality assurance is the minimization of error rates in order to enhance patient safety, six sigma or sigma metrics were used to assess the analytical quality of automated clinical chemistry, six sigma metrics is used in combination with total allowable error, method imprecision and bias. The goal is to attain the highest possible sigma scale within the acceptable limits of total allowable error. For assessment of sigma metrics results of serum glucose and lipid profile and verification of reference values for these analytes tested by automated chemistry analyzer in Medical City hospitals.Methods: In the present study, internal quality control (EQA) and external quality assessment (EQA) data were analyzed for the period from May to July 2017 using chemistry autoanalyzer (Siemens Dimension RxL Max) at the Teaching Laboratories of the Medical City. Mean, standard deviation, coefficient of variation, bias, total error and sigma metrics were calculated for glucose, cholesterol, triglycerides and HDL.Results: Excellent sigma values (≥6) were elicited for triglycerides (10.9), Satisfactory sigma values (≥3) were elicited for cholesterol (3.4) and HDL (3.4), while glucose performed poorly (2.3) on the sigma scale.Conclusions: Sigma metrics helps to assess analytical methodologies and augment laboratory performance. It acts as a guide for planning quality control strategy. It can be a self-assessment tool regarding the functioning of clinical laboratory. Triglycerides was the best performer when it was gauzed on the sigma scale, with a sigma metrics value of 10.9 and glucose had the least sigma metrics value of 2.5 so there is need for improvement and the method should be controlled with greater attention to ensure quality. 

Internal quality control in clinical chemistry: A teaching review

1987 ◽  
Vol 6 (4) ◽  
pp. 425-440 ◽  
Author(s):  
A. B. J. Nix ◽  
R. J. Rowlands ◽  
K. W. Kemp ◽  
D. W. Wilson ◽  
K. Griffiths
Keyword(s):  
Quality Control ◽  
Clinical Chemistry ◽  
Internal Quality Control ◽  
Internal Quality
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