scholarly journals Uncertainty of Measurement in Medical Laboratories

10.5772/62437 ◽  
2016 ◽  
Author(s):  
Paulo Pereira
Keyword(s):  
Uncertainty Of Measurement ◽  
Medical Laboratories

Quality management in medical laboratories

2010 ◽  
Vol 30 (02) ◽  
pp. 55-62
Author(s):  
M. Fritzer-Szekeres
Keyword(s):  
Quality Management ◽  
Medical Laboratory ◽  
Management Systems ◽  
The European Union ◽  
Quality Management Systems ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Systems Quality ◽  
Standard Iso 15189

SummaryDuring the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.

Verification of the Calculation Assumptions Applied to Solutions of the Acoustic Measurements Uncertainty

2015 ◽  
Vol 39 (2) ◽  
pp. 199-202
Author(s):  
Wojciech Batko ◽  
Renata Bal
Keyword(s):  
Normal Distribution ◽  
Confidence Intervals ◽  
Uncertainty Of Measurement ◽  
Acoustic Measurements ◽  
Uncertainty In Measurement ◽  
Sound Levels ◽  
Measurement Results ◽  
Analysis Of Results ◽  
Essential Problem ◽  
Expression Of Uncertainty

Abstract The assessment of the uncertainty of measurement results, an essential problem in environmental acoustic investigations, is undertaken in the paper. An attention is drawn to the - usually omitted - problem of the verification of assumptions related to using the classic methods of the confidence intervals estimation, for the controlled measuring quantity. Especially the paper directs attention to the need of the verification of the assumption of the normal distribution of the measuring quantity set, being the base for the existing and binding procedures of the acoustic measurements assessment uncertainty. The essence of the undertaken problem concerns the binding legal and standard acts related to acoustic measurements and recommended in: 'Guide to the expression of uncertainty in measurement' (GUM) (OIML 1993), developed under the aegis of the International Bureau of Measures (BIPM). The model legitimacy of the hypothesis of the normal distribution of the measuring quantity set in acoustic measurements is discussed and supplemented by testing its likelihood on the environment acoustic results. The Jarque-Bery test based on skewness and flattening (curtosis) distribution measures was used for the analysis of results verifying the assumption. This test allows for the simultaneous analysis of the deviation from the normal distribution caused both by its skewness and flattening. The performed experiments concerned analyses of the distribution of sound levels: LD, LE, LN, LDWN, being the basic noise indicators in assessments of the environment acoustic hazards.

Development and Validation of HPLC/UV-Spectrophotometric Procedures for Metronidazole Quantitative Determination

2018 ◽  
Vol 9 (3) ◽  
Author(s):  
Klimenko Lina Yu ◽  
Shkarlat Galyna L ◽  
Shovkova Zoia V ◽  
Yaremenko Vitaliy D ◽  
Shpychak Oleg S
Keyword(s):  
Quantitative Determination ◽  
Sodium Hydroxide Solution ◽  
Gradient Elution ◽  
Calibration Model ◽  
Column Temperature ◽  
Medical Laboratories ◽  
Accuracy And Precision ◽  
Development And Validation ◽  
Gradient Elution Mode ◽  
Potential Object

Metronidazole is the most popular representative of antiprotozoal medicines from the group of 5-nitroimidazoles. Metronidazole blocks the enzymes of alcohol dehydrogenase and acetaldehyde dehydrogenase, therefore when its joint taking with alcohol it is observed the strong intoxication syndrome and fatal poisonings too. Therefore metronidazole can be a potential object of chemical toxicological investigations. The purpose of our paper is to develop HPLC/UV-procedure of metronidazole quantification with application of the system of HPLC-analyzer MiLiChrome® A-0230 implemented in practice of forensic medical laboratories in Russia and Ukraine and carry out step-by-step validation of the developed procedure. Chromatographic conditions: Eluent A (0.2 M LiClO4 – 0.005 M HClO4) and Eluent B (acetonitrile) wereused as the mobile phase components; HPLC microcolumn Ø2×75 mm and ProntoSIL 120-5-C18 AQ, 5 μm were used as an analytical column; temperature was 40°С; flow rate was 100 μl/min; gradient elution mode was from 5% to 100% Eluent B for 40 min, then 100% Eluent B for 3 min; detection was performed at 277 nm. Retention time for metronidazole is 5.95 min. Since metronidazole is easy soluble and stable enough in the solutions of diluted alkalis 0.001 M sodium hydroxide solution has been proposed for preparation of the solutions in developing HPLC/UV-procedure of metronidazole quantification. Validation of the procedure has been carried out in the variants of the method of calibration curve and method of standard by such parameters as in process stability, linearity/calibration model, accuracy and precision within 3 different analytical runs using different batches of reagents and different glassware; experiments have been performed by three different analysts. New procedure of metronidazole quantitative determination by the method of HPLC/UV has been developed. Its validation has been carried out and acceptability for application has been shown.

Assessment of laboratory errors and best laboratory practices

2016 ◽  
Vol 5 (07) ◽  
pp. 4704
Author(s):  
Syed Riaz Mehdi* ◽  
Sharique Ahmad ◽  
Noorin Zaidi
Keyword(s):  
External Quality Control ◽  
External Quality ◽  
Iso 15189 ◽  
Laboratory Errors ◽  
Control Programs ◽  
Medical Laboratories ◽  
Laboratory Error ◽  
Active Communication ◽  
Total Testing Process ◽  
Five Phases

Laboratory error is defined by ISO 22367 as “Failure of planned actions to be completed as intended or use a wrong plan to achieve an aim”. Lundeberg in 1981 outlined the concept of Total Testing Process (TTP) and Plebani elaborated it further and classified the whole testing process into five phases of Pre-Pre Analytic, Pre Analytic, Analytic, Post Analytic and Post - Post Analytic. The errors have to be identified and resolved in each phase of the process. The medical laboratories have to run Internal and External Quality Control programs and abide by the guidelines of ISO 15189 in order to be accredited by bodies like JCI, CAP or NABL. Active communication and regular interaction between the clinicians and the laboratory is recommended during Pre Analytic and Post Analytic phases of TTP in order to achieve the target of Best Laboratory Practices. 

ISO/TS 20914:2019 – a critical commentary

2020 ◽  
Vol 58 (8) ◽  
pp. 1182-1190 ◽  
Author(s):  
Ian Farrance ◽  
Robert Frenkel ◽  
Tony Badrick
Keyword(s):  
Measurement Uncertainty ◽  
Measurement Data ◽  
International Normalized Ratio ◽  
Medical Laboratory ◽  
Uncertainty In Measurement ◽  
Medical Laboratories ◽  
Functional Relationships ◽  
Critical Commentary ◽  
Combined Uncertainty ◽  
Expression Of Uncertainty

AbstractThe long-anticipated ISO/TS 20914, Medical laboratories – Practical guidance for the estimation of measurement uncertainty, became publicly available in July 2019. This ISO document is intended as a guide for the practical application of estimating uncertainty in measurement (measurement uncertainty) in a medical laboratory. In some respects, the guide does indeed meet many of its stated objectives with numerous very detailed examples. Even though it is claimed that this ISO guide is based on the Evaluation of measurement data – Guide to the expression of uncertainty in measurement (GUM), JCGM 100:2008, it is with some concern that we believe several important statements and statistical procedures are incorrect, with others potentially misleading. The aim of this report is to highlight the major concerns which we have identified. In particular, we believe the following items require further comment: (1) The use of coefficient of variation and its potential for misuse requires clarification, (2) pooled variance and measurement uncertainty across changes in measuring conditions has been oversimplified and is potentially misleading, (3) uncertainty in the results of estimated glomerular filtration rate (eGFR) do not include all known uncertainties, (4) the international normalized ratio (INR) calculation is incorrect, (5) the treatment of bias uncertainty is considered problematic, (6) the rules for evaluating combined uncertainty in functional relationships are incomplete, and (7) specific concerns with some individual statements.

Examining Exclusionary Conduct of HMOs and PPOs: A Case Comment on Northwest Medical Laboratories v. Blue Cross and Blue Shield of Oregon

1991 ◽  
Vol 17 (3) ◽  
pp. 271-288
Author(s):  
Debra M. Levitt
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Health Care Industry ◽  
Medical Laboratory ◽  
Care Providers ◽  
Court Of Appeals ◽  
Medical Laboratories ◽  
Care Industry ◽  
Antitrust Analysis ◽  
Blue Shield

As the climate of the health care industry has changed to one of cost-containment and competition through the growth of HMOs and PPOs, health care providers have become the subjects of antitrust litigation. One such case, Northwest Medical Laboratories v. Blue Cross and Blue Shield of Oregon, involved a medical laboratory and a radiology center who claimed that they were victims of an illegal group boycott after defendant's pre-paid health plan denied them preferred provider status. The Oregon Court of Appeals, using the traditional antitrust analysis applied to other industries for decades, failed to consider the intricacies that exist within the health care industry. This result led to an inaccurate market share computation and an inadequate rule of reason analysis. This Comment examines the shortcomings of the Northwest Medical opinion and argues that, in applying the antitrust laws to the health care industry, courts in future cases must recognize and respect the unique features of the business of providing health care.

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