Unit METHODS FOR EVIDENCE-BASED PROFESSIONAL PRACTICE AND ELEMENTS OF RISK MANAGEMENT

RISK MANAGEMENTE IN CLINICAL LABORATORY

Code	50995002
CFU	2
Teachers	Silvia Covalovo (Codocenza)
Hours	18 ore (Codocenza) - Silvia Covalovo
Learning activities	Caratterizzante
Area	Scienze e tecniche di laboratorio biomedico
Academic discipline	MED/46
Type of study-unit	Obbligatorio (Required)
Language of instruction	Italian
Contents	Contextualization of the concepts of error, risk and clinical risk in health care. Illustration of methods and approaches to risk management. Definition and action of clinical risk management. Application of clinical risk management in laboratory medicine.
Reference texts	Material provided by teacher
Educational objectives	At the end of the course the student must acquire the fundamentals necessary to understand the purpose of the programs of risk management in healthcare. Must be familiar with the tools used for this purpose and to identify those most likely to be applied in laboratory medicine
Prerequisites	No specific pre-requisites are required.
Teaching methods	Face to face lessons, Classroom exercises, Learning assessment test
Learning verification modality	The verification of this module takes place in the corresponding teaching context, through an investigation in oral form on all the arguments expected by the program. Normally there is only one question for this form.
Extended program	Introduction to clinical risk Risk management in the context of clinical governance Origins of the risk culture. The efficiency and effectiveness of the quality appropriateness of care: the centrality of the patient safety The concept of risk: business risk and the concept of risk in health systems Epidemiology of errors Concept of error The error in healthcare The consequences of errors: costs, direct costs, indirect costs, social costs Errors and adverse events From the culture of blame to the culture of risk Classification of errors The errors in health care Errors in laboratory medicine The clinical risk management in health care The clinical risk in health Methods for the analysis of the risk Methods for the analysis of reactive Methods for the analysis proactive Risk management in laboratory medicine Errors in laboratory medicine The laboratory process Choice of methods for the analysis of risk Practical application of a methodology for risk analysis to a laboratory process Defining the examination Process Analysis Definition of error modes Risk assessment Definition of corrective measures

RESEARCH METHODOLOGY AND EBML

Code	50992901
CFU	1
Teacher	Elena Monacelli
Teachers	Elena Monacelli
Hours	12 ore - Elena Monacelli
Learning activities	Caratterizzante
Area	Scienze e tecniche di laboratorio biomedico
Academic discipline	MED/46
Type of study-unit	Obbligatorio (Required)

STATISTICS IN BIOMEDICAL RESEARCH

Code	50668502
CFU	2
Teacher	Donatella Siepi
Teachers	Donatella Siepi
Hours	24 ore - Donatella Siepi
Learning activities	Caratterizzante
Area	Scienze interdisciplinari
Academic discipline	SECS-S/02
Type of study-unit	Obbligatorio (Required)
Language of instruction	Italian
Contents	General information on statistics and its use in medicine. Aims and methods of statistical analysis, statistical characteristics and classification. Descriptive Statistics: principli indices descriptive statistics, their use and their representation Epidemiology and Clinical Trials Probability. Inferential statistics. Evaluation of data usage and processing Correlation. Linear regression. Survival curves
Reference texts	Fowler J., Jarvis P., Chevannes M.: STATISTICA PER LE PROFESSIONI SANITARIE. Edizioni EdiSES.
Educational objectives	The main objective of the course is to provide students with adequate knowledge in order to understand the use of the elements of statistical research. At the end of the course the student will acquire the knowledge needed to understand the elements of descriptive and inferential statistics found in the scientific literature, organize, process, interpret and communicate scientific data appropriately summary information obtained.
Prerequisites	In order to understand and use the concepts described in the teaching it requires knowledge of basic elements of Mathematics, Computer and English.
Teaching methods	Face-to-face lessons: lectures on all subjects of the module.
Learning verification modality	The exam includes an oral exam consists in a collegial discussion, with the presence of the teachers of the various modules, of a discussion of 25-30 minutes aimed at ascertaining the level of knowledge and understanding reached by the student on the topics presented in class and listed in the program. The student must demonstrate the ability to know the epidemiological characteristics of various diseases, what is a literature search and what tools to use to effectively implement and finally the notions statistics to be able to read and understand a paper. The oral test will also verify the communication skills of the student, his command of the language, the ability to apply the acquired skills and develop solutions in independent judgment.
Extended program	General information on statistics and its use in medicine. Aims and methods of statistical analysis, statistical characteristics and classification. Decrittive Statistics : Measurements and sampling in health studies. Data analysis and presentation. Presentation of the results of tables. Main graphic representation (histograms, etc.). Absolute frequencies, relative, cumulative. Distribution of frequencies. Measures of central tendency. Measurement variability. Symmetric and asymmetric frequency curves. Epidemiology Measures of disease frequency: prevalence and frequency. Types of studies. Confounding. Clinical Trials: History, nature of clinical trials. Types of clinical trials. Ethical aspects. Probability. Definition and theories of probability. Event and event space. The measure of probability. Basic principles of probability. Bayes' theorem and applications. Specificity and Sensitivity. Positive predictive value, negative predictive values. Relative risk and odds-ratio. ROC-curves and their interpretation. Empirical law of the case. Theoretical probability distributions: Gaussian and Binomial and Poisson. Applications. Inferential statistics. Outline of the central limit theorem. Standard error. Significance levels. Confidence intervals. Standardized normal distribution and distribution of T-student. Hypothesis testing: the concept of hypothesis, error I ° species and II species. Power of the test. Tests based on a sample. Z-test for the mean. One-tailed test and two-tailed. Comparison between means for paired samples and independent samples. Parametric and non-parametric statistics. Analysis of variance. Test for multiple comparisons. ¿2 test: meaning, properties and applications. Correlation for the association between qualitative variables, the Pearson coefficient, Spearman coefficient. Linear regression. Tables and survival curves.

QUALITY'S EVALUATION AND CONTROL OF DIAGNOSTIC SERVICE

Code	50669001
CFU	1
Teachers	Patrizia Babini (Codocenza)
Hours	12 ore (Codocenza) - Patrizia Babini
Learning activities	Caratterizzante
Area	Scienze e tecniche di laboratorio biomedico
Academic discipline	MED/46
Type of study-unit	Obbligatorio (Required)
Language of instruction	Italian
Contents	Il corso è organizzato in una serie di lezioni frontali su tutti gli argomenti del programma. Il corso si prefigge di far conoscere agli studenti le norme ed i requisiti necessari per implementare un Sistema di Gestione delle Qualità, necessario per perseguire l’accreditamento istituzionale. Saranno affrontati gli aspetti necessari per autovalutare, monitorare e migliorare la qualità e la sicurezza delle prestazioni. In particolare, verrà trattata la disciplina in materia di accreditamento istituzionale delle strutture sanitarie prevista nella Regione Umbria, basata principalmente su requisiti previsti dalle norme ISO 9001.
Reference texts	• Materiale fornito dal docente • Proposta di modello per l’accreditamento istituzionale delle strutture di medicina di laboratorio. Agenas – Giugno 2015 http://www.agenas.it/images/agenas/accreditamento/manuali_new/Proposta_modello_accreditamento_Laboratori.pdf Per approfondimenti: Guida pratica all’accreditamento dei laboratory clinici. D. Burnett, M. Plebani. Biomedia Source Books
Educational objectives	Lo studente sarà in grado di conoscere e comprendere il significato del Sistema di Gestione della Qualità di un’azienda sanitaria in generale e dei servizi di medicina di laboratorio in particolare, il modello regionale, le modalità di verifica del sistema stesso e gli strumenti in uso nelle strutture. Lo studente, al termine del corso, sarà in grado di redigere una procedura, e di attivare sistemi di verifica della qualità e azioni di miglioramento.
Prerequisites	Lo studente dovrebbe avere conoscenze di base sui concetti di qualità e standard.
Teaching methods	Lezioni frontali
Learning verification modality	Verifica orale svolta dal docente sui principali contenuti del programma di insegnamento.
Extended program	- Qualità nei servizi sanitari: Definizioni, dimensioni, campi di applicazione, controllo di qualità. - Accreditamento e certificazione: Definizioni, Origini del sistema di accreditamento, Accreditamento in Italia e nella Regione Umbria. - La norma ISO 9001:2015. Orientamento al cliente, Leadership, Coinvolgimento del personale, Approccio per processi, Miglioramento, Decisioni basate su evidenze, Gestione delle Relazioni. - Il Sistema di Gestione per la Qualità: Documentazione del SGQ, Politica per la Qualità, Manuale della Qualità, Procedure Operative, Istruzioni Operative, Le registrazioni. - I processi della medicina di laboratorio: Concetto di processo, Rappresentazione dei processi,Misure del processo - Valutazione e miglioramento continuo