7th edition of the Code of practice

The changing role of the HFEA Code of Practice

The current edition of the HFEA Code of Practice was published in January 2004.  Since then the ART sector has seen a number of technical advances, clinical innovations and legal developments.  Alongside these, the HFEA has published new guidance, Directions and advice to help centres innovate safely and responsibly, maintain the best quality of service for service users and encourage the spread of good practice throughout the sector.

Perhaps the most significant challenge now facing providers of fertility treatment in the UK is to prepare for the introduction of the EU Tissues and Cells Directive ? including the need for each centre to introduce a formal quality management system.

The introduction of new European requirements and the extension of these to over 100 previously unregulated centres, on the one hand, and, on the other, the need to minimise the burden that this places on centres. Also the need to streamline the process of regulation call not merely for a new code of practice but for a complete re-thinking of the way the Code is delivered, updated and used.

The HFEA is now developing a completely re-designed code of practice to help centres meet these challenges.  The new Code will comprise two parts:

(1) the HFEA Standards, which contains specifications that centres are required to show they can meet, including those required for compliance with the new legislation.*

(2) guidance on how these specifications should be met (consolidating much of the content of the existing Code of Practice).

The new Code will:

• consolidate all extant HFEA guidance from the previous Code of Practice and subsequent Chair's letters with the HFEA Standards
• distinguish clearly between mandatory and advisory specifications for easy reference
• link each standard to the underlying legislation, licence conditions or Directions, and to HFEA guidance on how that standard should be met, as well as to relevant forms and other sources of advice and information
• provide a framework of guidance on which centres can develop their quality manuals and detailed standard operating procedures (SOPs) as required by the new legislation
• be updatable, so amendments can be seamlessly incorporated into the living Code rather than added on through a variety of different letters and communiqués, as at present
• be available in the way that best suits the user, including online and loose-leaf printed versions.
  

Online users will:

• be notified of new and forthcoming updates when they log on and be able to sign up to receive automatic email notification
• find updates automatically incorporated into the Code when they come into effect whilst always being able to retrieve the complete version that was in force on any previous date
• be able to search, filter information and navigate through the text using hyperlinks
  

Loose-leaf users will:

• receive prompt updates automatically whenever new HFEA guidance is issued which can be filed directly into their main work
• be provided with clear filing instructions, a checklist and release lines to ensure that their version is complete and up-to-date thereby reducing the risk of overlooking important requirements
  

The new Code will not, however, introduce any new requirements other than those demanded by the new legislation; in certain cases, requirements will be simplified in line with 'better regulation' principles.

Read more about the consultation.