Quality Assurance in Clinical Chemistry: A Touch of Statistics and A Lot of Common Sense

Theodorsson, Elvar

doi:10.1515/jomb-2016-0012

Cited by 34 publications

(25 citation statements)

References 52 publications

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“…The complementarity of the measurement uncertainty assessment and calculation of the TEa (46) is directly proposed in addition. However, in practice, laboratories have a much more important standardization in the implementation of good laboratory practice than the monitoring of current discussions on TEs and MUs, which are still not harmonized in practice (47).…”

Section: Systematization Of Measurement Uncertainty In Medical Laboramentioning

confidence: 99%

Uncertainty of Measurement in Laboratory Medicine

Milinković¹,

Ignjatović²,

Šumarac³

et al. 2018

Journal of Medical Biochemistry

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SummaryAn adequate assessment of the measurement uncertainty in a laboratory medicine is one of the most important factors for a reliable interpretation of the results. A large number of standards and guidelines indicate the need for a proper assessment of the uncertainty of measurement re sults in routine laboratory practice. The available docu ments ge nerally recommend participation in the proficiency schemes/ external quality control, as well as the internal quality control, in order to primarily verify the quality performance of the method. Although all documents meet the re quirements of the International Standard, ISO 15189, the standard itself does not clearly define the method by which the measurement results need to be assessed and there is no harmonization in practice regarding to this. Also, the uncertainty of measurement results is the data relating to the measured result itself, but all factors that influence the interpretation of the measured value, which is ultimately used for diagnosis and monitoring of the patient's treat ment, should be taken into account. So in laboratory medicine, an appropriate assessment of the uncertainty of the measurement results should have the ultimate goal of reducing diagnostic uncertainty. However, good profes sional laboratory practice and understanding analytical aspects of the test for each individual laboratory is ne ces sary to adequately define the uncertainty of measurement results for specific laboratory tests, which helps to imple ment good clinical practice. Also, setting diagnoses in medicine is a decision with a certain degree of uncertainty, rather than statistically and mathematically calculated conclusion.Keywords: ISO 15189, laboratory medicine, measurement uncertainty Kratak sadr`ajAdekvatna procena nesigurnosti rezultata merenja u biohemijskoj laboratoriji je jedan od najzna~ajnijih faktora za pouzdanu interpretaciju rezultata. Veliki broj standarda i vodi~a ukazuju na neophodnost pravilne procene nesigurnosti rezultata merenja u rutinskoj laboratorijskoj praksi. Dostupni dokumenti uglavnom preporu~uju u~e{}e u {e -mama osposobljenosti/spolja{njoj kontroli kvaliteta, kao i svakodnevno merenje unutra{njih kontrola kvaliteta, kako bi se primarno proverilo izvo|enje metode. Mada svi dokumenti zadovoljavaju zahteve internacionalnog standarda ISO 15189, sam standard ne defini{e jasno metodu kojom treba procenjivati nesigurnost rezultata merenja i ne postoji harmonizacija u praksi. Tako|e, nesigurnost rezultata merenja je podatak koji se odnosi na sam izmereni rezultat, ali treba uzeti u obzir sve faktore koji uti~u i na interpretaciju izmerene vrednosti, koja se u krajnjem koristi za dijagnozu i pra}enje le~enja pacijenta. Tako da u laboratorijskoj medicini odgovaraju}a procena nesigurnosti rezultata merenja treba da ima za krajnji cilj smanjenje dijagnosti~ke ne sigurnosti. Ipak, dobra profesionalna laboratorijska praksa i razumevanje analiti~kih aspekata testa za svaku poje dina~nu laboratoriju je neophodno da bi se adekvatno definisala procena nesig...

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Section: Systematization Of Measurement Uncertainty In Medical Laboramentioning

confidence: 99%

Uncertainty of Measurement in Laboratory Medicine

Milinković¹,

Ignjatović²,

Šumarac³

et al. 2018

Journal of Medical Biochemistry

View full text Add to dashboard Cite

show abstract

“…Prior to implementation of the QMS, internal audit was carried out and the findings showed some shortcoming in terms of calibration prior to sample analysis. The staff knowledge, skills and common sense are essential for assuring quality in the laboratory (10). Quality assurance and quality control are vital for correct diagnosis.…”

Section: / Tamil Selvi and Ankanagarimentioning

confidence: 99%

Implementing QMS and Accreditation Standards in Medical Diagnostics for Quality of Services

Selvi¹,

Ankanagari

2019

mljgoums

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Background and Objectives: Implementing quality management system (QMS) in medical laboratories improves quality of procedures and enhances the staff's skill development. It prevents frequent inaccuracies in both clinical and laboratory procedures caused by lack of regulatory compliance, safety precautions and inadequate facilities. The purpose of this study is to evaluate effect of implementing QMS based on essential standards NABH (MLP) and NABL (ISO 15189:2012) in a medical laboratory on quality of services. Methods: Important quality indicators such as external quality assurance services (EQAS), rework, turnaround time (TAT) and feedback were monitored for four months, following implementing the QMS standards in a medical laboratory. Results: We found that implementation of the QMS program improved the tested indicators of quality. Overall percentage of rework reduced significantly. Conclusion: Implementation of QMS improves overall quality of laboratory procedures. It significantly reduces laboratory errors and progressively improves quality, efficiency, and outcomes, thus enabling delivery of timely and accurate services for patients.

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“…The year after that, he discovered the tubercle bacillus by other special culture and staining methods and formulated a rule for determining the specificity of disease-causing organisms. The rule, called Koch's postulates or Koch's law, stipulated that the specificity of a pathogenic microorganism could only be established if: (I) it is present in all cases of the disease, (2) inoculations of its pure cultures produce disease in animals, (3) from these cultures it can again be obtained, and (4) then it can again be propagated in pure cultures. In 1883, Koch discovered Cholera vibrio and recognized its routes of transmission as drinking water, food and clothing.…”

Section: Transformation Of Medicine Bedside To Laboratory Medicinementioning

confidence: 99%

Medicine and its Epistemological shift of body of Knowledge: Critical View from Socio-Philosophical Perspectives

Patra¹

2018

IJTSRD

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The medicine represents a specific type of knowledge about the human body that is applied to either care for or cure of the recipient of medical attention nature of medicine is certainly an achieve importance facing twenty-first century by socio-philosophers of medicine. One reason for its importance is that the question addresses the vital topic of Body of Knowledge and how physicians should practice medicine. During the turn of the twenty clinicians and other medical pundits have begun to accept evidence-based medicine, or EBM to Laboratory Medicine, as the best way to practice medicine. Proponents of EBM claim that physicians should engage in medical practices based on the best scientific and clinical evidence available, especially from randomized controlled clinical trials, systematic observations, and meta-analyses of that evidence, rather than on patho-physiology or an individual physicians clinical experience. Proponents also claim that EBM represents a paradigmatic shift away from traditional medicine. One specific objection is that application of evidence from population based clinical trials to the individual patient within the clinic is not as easy to accomplish as EBM proponents realize. In response, some clinicians propose patient medicine (PCM). Patient-centered advocates include the patient's personal information in order to apply the best available scientific and clinical evidence in treatment. The focus then shifts from the patience's disease to the patience's illness experience. The key for the practice of patient-centered medicine is a physician's effective communication with the patient.

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Quality Assurance in Clinical Chemistry: A Touch of Statistics and A Lot of Common Sense

Cited by 34 publications

References 52 publications

Uncertainty of Measurement in Laboratory Medicine

Uncertainty of Measurement in Laboratory Medicine

Implementing QMS and Accreditation Standards in Medical Diagnostics for Quality of Services

Medicine and its Epistemological shift of body of Knowledge: Critical View from Socio-Philosophical Perspectives

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