QUALITY MANAGER TISSUE INSTITUTE AND BLOOD CENTER

This training aims to provide the technical knowledge necessary to design, manage and maintain a Quality System at a highly specialized health care facility (Transfusion Service, Tissue Institute, Transplant Program), in compliance with current regulatory requirements.

The training is structured in 4 modules plus a final examination. 
Successful completion of the final exam will allow for a certificate of "Quality Manager in Transplantation Center, Blood Ban."

MODULE 1 - QUALITY. RISK AND SAFETY
The course aims to provide participants with the tools to be able to implement, manage and improve their quality system within a healthcare facility that carries out manipulation, management and infusion of cell therapy products, tissues and blood products. .
After having analyzed the difference between certification and accreditation, the main characteristics of some accreditation standards in the healthcare sector relating to tissue institutes, laboratories and transfusion services will be identified.
Quality system development and risk management models will be proposed and then concluded with the introduction of the concept of auditing.
Plan
-Differences between certification and accreditation
-Basics of a quality system in a healthcare facility.
-How to read an accreditation standard.
-Model for the development of a quality and risk management system.
-Introduction to the concept of internal audit
-Exercises with working groups

MODULE 2: Design and implement organizational and document system.
One of the tasks of the Quality Manager working in a highly specialized health care facility (Tissue Institute, Transfusion Service, Biobanks) is to design, develop and improve the document system. All accreditation and certification standards in health care require the presence of a document system, in fact in the different regulations there are more or less specific requirements detailing the documents that must be present. During the second module of the Quality Manager qualification course at a specialized facility, these aspects will be systematically addressed, providing methodologies and operational tools for improving the document system.
Program
- General requirements of the document system
- Specific documentary requirements required by accreditation standards
- The elements necessary for the development and improvement of an organizational and document system
- The steps for designing, creating, and improving the organizational and document system: a model

MODULE 3: Errors, accidents, adverse events and risk management.
Accreditation and certification standards require the management of errors and nonconformities. In the 3 module qualifying the Quality Manager at a specialized facility, the types of errors, the classification found in healthcare accreditation standards and the proper way to manage and prevent them will be explained. Root Cause Analysis will also be explored, providing operational tools for both their management and prevention.
Program
- The theory of errors
-The types of errors
-Distinction between errors, accidents, adverse events
-A methodology for preventing errors
-A methodology for handling errors

MODULE 4 -Audit Management.
The internal auditing system is a basic requirement for any quality system and is a requirement of all certification or accreditation standards.
For this reason, the 4 Quality Manager qualification module will focus on how to manage an audit.
Audit techniques, tools to be used, items to be verified and the proper way to perform them will be analyzed.
Program
- The types of audits
- Rules of audits
- Auditing techniques
- The tools for managing an audit
- The elements to be verified in a transfusion service, tissue institute, and transplantation program
- Typical critical issues and nonconformities encountered during an audit

FINAL EXAMINATION: Successful completion of the final examination will result in a certificate of"QUALITY MANAGER IN A TISSUE INSTITUTE, TRANSPLANTATION PROGRAM, TRANSFUSION SERVICE And to join the INTERNATIONAL REGISTER OF QUALITY MANAGERS.