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29 September 2006

Dear Colleague

General Directions on Records

The Authority has approved the issue of new general directions on records, which come into force on January 1, 2007.  This makes Electronic Data Interchange (EDI) the standard method for licensed centres to submit their records relating to registrations, treatments and outcomes.  From January 1 2007 all existing directions relating to the submission of data to the HFEA Register become obsolete. 

Paragraph 2 of these directions draws attention to and reiterates the duties of Persons Responsible in relation to patient records.

Paragraph 3 of these directions requires the use of EDI and defines allowable variations and exceptions.  Variations will be allowed to enable the use of clinical record systems linked to EDI; this must be agreed in writing by the HFEA.  Exceptions may be temporary or long term.  Long term exceptions are expected to be limited to centres with exceptionally low annual volumes of activity and must be defined and agreed by the HFEA in advance in writing.  Temporary exceptions may be allowed to manage the effect of systems failure.   The HFEA should be notified as soon as possible of problems that may require a temporary exception and will agree with the centres the nature of the exception, for example late submission when the system is restored, or a period of submission by paper forms.

Paragraph 4 of these directions details the submission timescales for information.  EDI provides the capability for information to be submitted immediately and frequently instead of through monthly batches.  Submission timescales have been amended to reflect this capability.

Should you have any queries in relation to these directions or should you wish to discuss a variation or exception for your licensed centre, please contact your QA Officer at the HFEA.

Lord Harries of Pentregarth
Interim Chair

Page last updated: 23 August 2012

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