Unit METHODOLOGY OF RESEARCH AND QUALITY SYSTEMS

CLINICAL RISK MANAGEMENT IN THE LABORATORY

Code	A001530
CFU	2
Teacher	Silvia Covalovo
Teachers	Silvia Covalovo
Hours	18 ore - 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.
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 STATISTICS AND METHODOLOGY

Code	A001528
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.

EVALUATION AND QUALITY CONTROL OF DIAGNOSTIC SERVICES

Code	A001529
CFU	1
Teacher	Patrizia Babini
Teachers	Patrizia Babini
Hours	12 ore - Patrizia Babini
Learning activities	Caratterizzante
Area	Scienze e tecniche di laboratorio biomedico
Academic discipline	MED/46
Type of study-unit	Obbligatorio (Required)
Contents	the course aims to acquaint students with the standards and requirements necessary to implement a Quality Management System (model ISO 9001: 2008) important to improve the quality of their product \ service and the quality of its organization. The topics to be discussed will cover the definition and characteristics of the accreditation system, dealing, in particular, the path chosen by the Umbria region, mainly based on the requirements found in ISO 9001: 2008. Next will be dealt with the aspect of the characteristics and management of the documentation of a quality management system, then you will go to examine what are the main responsibilities of the management (planning, implementation, maintenance, and improvement of the QMS). Another aspect will be treated the management of resources (human, technological, etc.), then go on to analyze the whole process and address the main activities such as procurement, storage of products and under control of monitoring and measuring devices. The program will end talking about the monitoring, measurement, analysis, and improvement processes needed to demonstrate conformity of products, ensure compliance of the QMS and continually improve the effectiveness of the QMS.
Educational objectives	The student will be able to know what it is and how to make a in a Quality Management System Laboratory Analysis, an important achievement for the acquisition of accreditation Institutional