1) Designing and implementing

organisational and document system

One of the tasks of the Quality Manager working in a IVF LABORATORY centre is to design, develop and improve the document system; by document system is meant all the documentation (in paper or electronic format) used to provide evidence of the recording of the activities performed by the centre.

All accreditation and certification standards in the healthcare sector require the presence of a document system; in fact, in the various standards there are more or less specific requirements detailing the documents that must be present. During the second module of the qualification course for the Quality Manager in a specialised facility, these aspects will be systematically addressed, providing methodologies and operational tools for improving the document system.

Programme

• General requirements of the document system
• Specific documentary requirements of accreditation standards
• The necessary elements for the development and improvement of an organisational and document system
• The steps for designing, creating and improving the organisational and document system: a model
• The processes of a IVF LABORATORY centre: the processes of a IVF LABORATORY centre will be analysed (e.g. selection and assessment of suitability, egg collection/pick-up, transfer, clinical follow-up, sample labelling, storage of oocytes, sperm and embryos, etc.).

 

2) Errors, accidents, adverse events and risk management

Accreditation and certification standards require the management of errors and non-conformities. Errors are understood to be all those events of a clinical, organisational or procedural nature that may occur during the performance of the activity (e.g. error during blastocyst transfer, labelling error).

In the 3rd module on the qualification of the Quality Manager at a IVF LABORATORY centre, the types of errors, their classification in healthcare accreditation standards and the correct way to manage and prevent them will be explained. Root Cause Analysis will also be explored in depth, providing operational tools for both their management and prevention.

Programme 

• The theory of errors
• Types of errors
• Distinction between errors, accidents, adverse events
• A methodology to prevent errors
• A methodology will manage the errors

 

3) Audit Management

 Internal auditing is a fundamental requirement for any quality system and is a requirement of all certification or accreditation standards. For this reason, the 4th qualification module of the Quality Manager in a IVF LABORATORY centre will focus on how to manage an audit. The audit techniques, the tools to be used, the elements to be checked and the correct way to carry them out will be analysed.

Programme

 

• Types of audits
• Audit Rules
• Techniques Tools for Managing an Audit
• The elements to be verified in a IVF LABORATORY laboratory
• Critical issues and typical non-conformities in a IVF LABORATORY laboratory
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FINAL EXAMINATION

Successful completion of the final examination will lead to the certificate of 'Quality Manager in a IVF LABORATORY Centre' and to the certification of competence as a Quality Manager in IVF LABORATORY

In addition, there will be inclusion in the international QM register

international recognised by HQM Research Center Ltd