QUALITY MANAGER IN A PMA CENTER

The aim of the course is to create the role of Quality Manager in a Fertilization Centre. During the course, participants will be provided with the tools to be able to design, implement, manage and improve the organizational and quality system of a fertilization center, in compliance with regulatory requirements at both a national and international level.

The course is qualified by the skills certification body ACS Italia. At the end of the qualification process, after passing the exam, the participant will be registered in the international register of QUALITY MANAGERS IN PMA CENTERS

The training course is structured in 4 modules plus a final test.

Design and implement the Quality System

The course aims to provide participants with the tools to be able to implement, manage and improve their quality system within a level I, II and III fertilization centre, relating to all the activities provided within it (both of a clinical and technical-biological).

After analyzing the difference between certification and accreditation, the main characteristics of some accreditation standards in the health sector relating to MAP centers will be identified. We will propose development models for the quality and risk management system and then conclude with an introduction to the concept of auditing.

Program

14 pm: Introduction of the course

14.15pm - 17.30pm: In-depth study of the following topics:

• Differences between certification and accreditation
• Bases of a quality system in a PMA center
• The quality requirements required by the PMA legislation
• Model for the development of a quality and risk management system
• A case study of application of the risk management system.
• Introduction to the concept of internal audit

17.30 - 18.30: Individual exercises

18.30 - 19.30: Learning test

The learning test will be available at the end of the individual exercises

Design and implement an organizational and documentary system

One of the tasks of the Quality Manager who works in a PMA center is to design, develop and improve the document system; document system means all the documentation (in paper or electronic format) used to give evidence of the registration of the activities provided by the center.

All the accreditation and certification standards in the health sector require the presence of a document system, in fact in the various regulations there are more or less specific requirements that detail the documents that must be present. During the second module of the qualification course of the Quality Manager at a specialized structure these aspects will be dealt with in a systematic way, providing methodologies and operational tools for improving the document system.

Program

14 pm: Introduction of the course

14.15pm - 17.30pm: In-depth study of the following topics:

• General requirements of the document system
• Specific document requirements required by accreditation standards
• The elements necessary for the development and improvement of an organizational and documentary system
• The phases for the design, creation and improvement of the organizational and documental system: a model
• The processes of a ART centre: the processes of a ART center will be analyzed (e.g. selection and suitability assessment, oocyte collection/pick-up, transfer, clinical follow-up, sample labelling, oocyte storage, spermatozoa and embryos, etc).

 

17.30 - 18.30: Individual exercises

18.30 - 19.30: Learning test

The learning test will be available at the end of the individual exercises

Errors, accidents, adverse events and risk management

Accreditation and certification standards require the management of errors and non-conformities. By error we mean all those events of a clinical, organizational, procedural nature that can occur during the execution of the activity (eg error during the transfer of blastocyst, labeling error).

In the third qualification module of the Quality Manager at a PMA center, the types of errors, the classification present in the health accreditation standards and the correct management and prevention methods will be illustrated. The Root Cause Analysis will also be deepened, providing operational tools for both their management and prevention.

 

Program

14 pm: Introduction of the course

14.15pm - 17.30pm: In-depth study of the following topics:

• The theory of errors
• The types of errors
• Distinction between errors, accidents, adverse events
• A methodology to prevent mistakes
• A methodology to manage them

17.30pm – Exercises

18.30 - 19.30: Learning test

The learning test will be available at the end of the individual exercises

Audit management

The internal auditing system represents a fundamental requirement for every quality system and is a requirement required by all certification or accreditation standards. For this reason, the 4th qualification module of the Quality Manager in a PMA center will focus on how to manage an audit. The audit techniques, the tools to be used, the elements to be checked and the correct method of execution will be analyzed.

Program

14 pm: Introduction of the course

14.15pm - 17.30pm: In-depth study of the following topics:

• Types of audits
• Audit rules
• Techniques and tools for managing an audit
• The elements to be verified in a PMA laboratory
• The typical criticalities and non-conformities of a PMA laboratory

17.30 - 18.30: Individual exercises

18.30 - 19.30: Learning test

The learning test will be available at the end of the individual exercises

FINAL EXAM

Passing the final exam will allow you to obtain the certificate of "Quality Manager in a PMA Center" and to obtain the certification of skills, as Quality Manager in PMA by ACS Italia, a certification body for publicly controlled personnel.

Furthermore, there will be inclusion in the international register of international QMs recognized by HQM Research Center Ltd

Program

14 pm: Introduction

14.00pm – 15.00pm: Illustration of the exam

15.00 - 19.00: Individual examination