1,721,028 research outputs found
Importance of control materials in quality assessment of cyclosporine determination.
No full textThe importance of control materials in intralaboratory quality assessment of cyclosporine A determination was analyzed. Two types of control materials and a human pool serum were evaluated. The first material was a two-level lyophilized cyclosporine human whole blood control (TLCC); the other was a tri-level therapeutic drug monitoring control (TDMC). The drug was determined in all specimens by both tritiated and iodinated radioimmunoassay. The coefficients of variation obtained in TLCC samples were significantly lower in comparison with the TDMC samples and similar to that of the human pool
Quality Indicators for the Total Testing Process
No full textISO 15189:2012 requires the use of quality indicators (Qls) to monitor and evaluate all steps of the total testing process, but several difficulties dissuade laboratories from effective and continuous use of Qls in routine practice. An International Federation of Clinical Chemistry and Laboratory Medicine working group addressed this problem and implemented a project to develop a model of Qls to be used in clinical laboratories worldwide to monitor and evaluate all steps of the total testing process, and decrease error rates and improve patient services in laboratory testing. All laboratories are invited, at no cost, to enroll in the project and contribute to harmonized management at the international level
A call-to-action for energy conservation and sustainability in the clinical laboratory: Experiences from the University of Padova
No full textObjectives: Healthcare has a considerable environmental impact, yet it has been largely overlooked. Clinical laboratories, in particular, consume significantly more energy and water per unit area compared to standard office buildings. It is crucial to raise awareness among laboratories about the significance of embracing eco-friendly practices. Numerous energy-saving measures do not incur additional costs but necessitate a shift in organizational culture and mindset. Design & methods: This paper conducts a cost-benefit analysis of energy consumption at the Laboratory Medicine Unit of University Hospital of Padova, beginning with laboratory refrigerators and freezers. Results: The need to rationalize the existing units, especially the combined refrigerators-freezers, and reorganize the contents of the Ultra-Low Temperature freezers with an energy-saving perspective has emerged. Conclusions: By implementing these practices, this initiative can gradually expand to encompass more green activities in the future
Cinetica e caratteristiche biologiche della risposta umorale all’infezione da SARS-CoV-2: implicazioni vaccinali
No full textWith the ongoing coronavirus disease 2019 (COVID-19) pandemic outbreak spreading all around the world, an extensive vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now universally regarded as one of the most effective strategies for counteracting the unremittent spread of this novel coronavirus. Nonetheless, the reasonable need to identify segments of the population in which vaccination shall be prioritized for avoiding a possible shortage of vaccines seems to collide with indications provided by many national and international healthcare organizations, that endorse widespread vaccination irrespective of a positive history of prior symptomatic or asymptomatic SARS-CoV-2 infection. To this end, this document provides an ad interim guidance aimed at prioritizing SARS-CoV-2 vaccination in people who are more likely to be infected, re-infected and/or to develop more aggressive COVID-19 illness, essentially based on routine assessment and monitoring of anti-SARS-CoV-2 immune response
Reply to W.G. Wood. Questionable results - who directs the EQAS organisers? Clin Chem Lab Med 2004;42:1073
No full textQuality specifications in EQA schemes: from theory to practice
No full textBACKGROUND:
External quality assessment (EQA) is a tool for quality management in clinical laboratories and its main objectives are assessment of participants and methods performance, training and advice. This paper describes the quality specifications used in EQA schemes of the Centre of Biomedical Research (CRB), in order to design schemes that can assess laboratory reliability performances, meet the changing needs and quality recommendations.
METHODS:
Quality specifications for control materials, statistical procedures and goals to assess laboratory performance have been applied and introduced in EQA schemes managed by CRB.
RESULTS:
The application of well-defined quality specifications has demonstrated effective. In particular, we report results on alkaline phosphatase and cholesterol obtained using commercial control materials and human serum controls, in two different EQA surveys; the inter-laboratory variability (CVinter%) for troponin I analysed with a diagnostic system and assigned values of CK-MB mass obtained using four different diagnostic systems; the percentage of acceptable performances obtained by means of the application of goals based on clinical criteria, biological variation, state-of-the-art and used for EQA schemes, and referring to some analytes with significant clinical values such as cholesterol, glucose, glycated hemoglobin and sodium.
CONCLUSIONS:
The design of reliable EQA schemes based on evidence-based quality specifications is a pre-requisite for supporting the quality improvement of clinical laboratories
Appropriateness of cholesterol and triglycerides reporting checked by External Quality Assessment programs
No full textBACKGROUND:
The recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention and the third Adult Treatment Panel report (ATPIII) released by the National Cholesterol Education Program are based on accumulating evidence concerning the contribution of lipoproteins and other risk factors in the development of coronary heart disease (CHD). The laboratories play an important role in the successful adoption of these guidelines.
METHODS:
In External Quality Assessment (EQA) programs managed by the Center of Biomedical Research, results and respective reference intervals (RI) are sent as laboratory's medical form. We assessed how well the 200 participants to EQA scheme 2002 for clinical biochemistry reported total cholesterol (TC) and triglycerides (TGs) results according to either European or National Cholesterol Education Program (NCEP) guidelines.
RESULTS:
Only 18% of laboratories reported total cholesterol concentrations correctly in terms of desirable, borderline-high, and high risk for the CHD development, 12% reported a single desirable value (180, 190, or 200 mg/dl), and 70% reported the RI (85 laboratories in the whole interval, 34 are the only upper reference limit and 15 are the desirable value in addition to RI). The upper reference limit was 200 mg/dl in 65% of cases, but 32% of laboratories presented higher limits, reaching values as high as 250-260 mg/dl. Only the 3.7% of laboratories reported triglyceride concentrations in terms of risk-oriented ranges for the CHD development, 6.8% the single desirable value, and 89.5% the RI.
CONCLUSION:
Our study demonstrates that the current practice of reporting results for cholesterol and triglycerides does not follow the guidelines, and appropriate changes are required to be mad
Indicatori di Qualità nei Point Of Care Testing (POCT): Sono efficaci?
No full textIl ruolo del professionista di laboratorio risulta cruciale
nella riduzione del rischio d’errore e nella ricerca delle
soluzioni più idonee a migliorare il processo. Il POCT
costituisce un esempio significativo di come la difficoltà
a conciliare le necessità cliniche, quelle del laboratorio
e le aspettative del paziente possa generare problemi
nei flussi operativi se non sono implementate adeguate
procedure e sistemi di assicurazione per la qualità
che garantiscano la qualità dei risultati. L’adozione
di appropriati Indicatori di Qualità (IQs) può risultare
uno strumento efficace per identificare e monitorare gli
eventi indesiderati e valutare l’efficacia delle azioni di
miglioramento intraprese.
Scopo di questo lavoro è riportare i risultati, raccolti
dal 2009 ad aprile 2014, relativi a 3 IQs- risultati non
accettabili nel CQI (PNA); coefficiente di variazione
fuori target (VCV); mancanza/ritardo di manutenzione o
sostituzione degli elettrodi per emogasanalizzatori (RIT)-
identificati per il monitoraggio dei problemi dei POCT (54
glucometri e 37 emogasanalizzatori) sotto il controllo del
nostro Dipartimento.
I risultati ottenuti dimostrano un generale miglioramento
delle prestazioni. In particolare:
Glucometri. La percentuale di PNA è diminuita nel corso
degli anni, da 8,6 (2009) a 1,5 (2013), e pari a 1,1 nei
primi mesi del 2014. La percentuale dei VCV è diminuita
da 1,6 (2010), per entrambi i livelli di CQI, a 0,3 e 0 (2013)
rispettivamente per il livello 1 e 2. Nei primi mesi del 2014
è pari a 0,7 per il livello 1 e a 0 per il livello 2.
Emogasanalizzatori. Il numero medio annuale di RIT
risulta costante nel tempo (3,68), dal 2009 al 2013, ma
ridotto (1,50) nei primi mesi del 2014.
Il miglioramento osservato dimostra l’efficacia delle
azioni correttive intraprese (sostituzione dei glucometri in
uso con glucometri più efficienti; sostituzione anticipata
degli elettrodi degli emogasanalizzatori in caso di
deriva del CQI) e l’utilità degli IQs come strumento di
assicurazione per la qualità. Inoltre l’uso degli IQs si è
dimostrato fondamentale nel migliorare la collaborazione
tra il personale clinico, che deve segnalare i problemi
evidenziati, ed i professionisti di laboratorio suggerendo
le più opportune azioni di miglioramento
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