As outlined in our Inspection strategy a clinic must compile the requested documents for the desk-based assessment and submit these within four weeks of request. These documents should be to hand for the most part and include copies of the clinic’s most recent audits, standard operating procedures, evidence of training and quality management items such as minutes from quality meetings or audit schedules etc. Clinics are also requested to complete our own audit tools.
Documents should be submitted in a comprehensive, easily accessible format, identifying which document relates to which Code of Practice guidance note.
Receiving these documents on time is critical for the inspection process, as our inspectors dedicate a significant amount of time in a carefully planned schedule to review them. Evidence provided within these documents allows the inspection team to assess a clinic’s compliance. Where they are provided late then inspectors will have little, or no opportunity to review them.
We know that there may occasionally be significant unforeseen circumstances which may affect the PR’s ability to submit these documents by the due date. In such situations the PR may request an extension of the due date for submission which must be communicated within good time to the inspection team. This will be considered on a case-by-case basis and where possible, we will try to accommodate such requests. It is expected that such cases are extremely rare.
If there is not enough time available to review late documents, the inspection team could decide that sufficient evidence has not been provided to demonstrate compliance for specific guidance notes, and a non-compliance might be cited within the inspection report for those regulatory areas not assessed.
Additionally, when clinics fail to submit the necessary information to the HFEA as part of the licensing process, this may result in a potential breach of Schedule 3B Paragraphs 1(1), (2) and (3) of the HFEA Act 1990 (as amended) and also is a breach of licence condition T9f.
