Chair's letter

01/08/2014 - CH(14) 01

01 August 2014

Dear Colleague

October 2014 update to the Code of Practice

On 1 October 2014, revised guidance in the Code of Practice and General Directions will come into force. The changes, affecting 15 Code of Practice guidance notes and two General Directions, reflect recent developments in policy and clarifications to existing guidance. Details of the changes are set out in the following annexes:

The main update relates to guidance on infection control, safeguarding, pre-operative assessment, the surgical pathway, and premises. As part of joint working, and reducing regulatory overlap with the Care Quality Commission (CQC), this guidance has been inspected against in the course of renewal inspections in England since October 2013. Following a review of the guidance and Authority agreement, it has now been updated and will apply to all licensed clinics from 1 October 2014. Further information on this is provided in Annex 1.

We have also made a number of other updates which are either clarifications to existing guidance following on from previous Clinic Focus articles, Chair’s and Chief Executive’s letters, or minor amendments to text or external links.

We will continue to publish both an online Code of Practice and retain the capability for you to view PDFs of guidance notes via the HFEA website.

The updates are currently available for information only via the August 2014 Clinic Focus article. These will come in to force on 1 October 2014 on which date the online Code of Practice on the HFEA website will be updated to reflect the changes.

We urge you and your staff to read the updated guidance notes and assure themselves they are familiar with any changes which might be relevant for them.



Sally Cheshire
Chair, Human Fertilisation and Embryology Authority

 

Annex 1: Summary of changes to guidance notes in the Code of Practice and changes to General Directions 0005 and 0011

Main updates

Guidance note 25 – Surgical Procedures
In October 2013, following agreement between the HFEA and the Care Quality Commission, the HFEA extended its remit to include the inspection of activities associated with the provision of surgical procedures carried out in connection with HFEA licensed treatment[1]. As a result, private clinics in England could apply to cancel their CQC registration, making the HFEA the sole regulator of private clinics in England. To ensure there were no regulatory gaps as a result of CQC deregistration, HFEA agreed to establish and inspect against guidance on infection control, safeguarding, pre-operative assessment and medicines management. The HFEA also reviewed and updated its guidance on requirements around premises.

In July 2014 the Authority agreed that all clinics in the UK should be able to show compliance with this guidance (where relevant to the activities of the clinic) in order to demonstrate that their premises and practices are suitable, in compliance with licence conditions T2 and T17.

For clinics in the devolved nations, whilst the regulation of healthcare in general is largely devolved, the regulation of ART is not. As such, the Authority considers it appropriate to require that all UK licensed clinics are compliant with the new guidance. However, we will ensure that the inspection of this guidance does not impose any new regulatory overlap. We will adopt a flexible approach to inspecting clinics in the devolved nations that takes into account the degree of scrutiny and the assessment of compliance made by our regulatory partners in the devolved nations. In practice this is likely to mean that if a clinic is able to show that their practices have been assessed as fully compliant by another regulatory body, then in liaison with the clinic we will consider whether the evidence of this regulatory body can be provided to the HFEA’s licensing committee as evidence of compliance.

We believe that the new guidance and inspection methodology has helped clinics improve their practice, and added real value to the inspections. If you have any questions about the guidance and upcoming changes, please contact Matthew Watts, Regulatory Policy Manager matthew.watts@hfea.gov.uk

Clarifications to guidance

Guidance note 2 – Staff
This guidance note has been updated to replace Health Professions Council (HPC) with Health and Care Professions Council (HCPC) throughout.

Guidance note 3 – Counselling
Two recent legal judgments on consent to storage and legal parenthood highlighted the importance for the offer of counselling to be recorded alongside the documentation of information provided to patients by the clinic. Paragraph 3.13 has been included to reflect this.

Guidance note 4 – Information to be provided prior to consent
As patients make greater use of centres’ websites, so the responsibility centres have to ensure the information they contain is fair and accurate becomes increasingly important. A Chair’s letter (CH(11)02) was communicated to this effect in May 2011 and the criteria outlined in the letter has been replicated in paragraph 4.5.

Guidance note 5 – Consent to treatment, storage, donation, training and disclosure of information
A Clinic Focus article in October 2012 reminded centres that gametes should not be taken from a person unless written, informed consent to storage has been obtained, as set out in the HFE Act. Paragraph 5.4 in guidance note 5 has been updated to remind centres that if a centre becomes involved in a case where a partner or family member of a deceased person intends to make an emergency application to the High Court, the centre should notify the HFEA.

Paragraph 5.16 has been added to inform clinics that they should document that patients have been offered counselling before giving consent.

Guidance note 7 – Multiple Births
We have removed reference to the multiple births licence condition (T123) from ‘Mandatory requirements’. This was communicated to you in a Chair’s letter in December 2013 CH(13)03 and was removed from all centres’ licences, effective from 1 January 2014.

Guidance note 11 – Donor recruitment, assessment and screening
The independent Scientific Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) reviewed the donor selection criteria for men who have had sex with men (MSM). Paragraph 11.14(b) has been updated to reflect the guidance, which states there should be no specific restrictions regarding donations from MSM. A link to the SaBTO guidance has been included under ‘Other legislation, professional guidelines and information’.

Further to a Clinic Focus article in June 2010, we wanted to be clear in the Code of Practice that that there is no expectation that clinics match the ethnic background of the recipient to that of the donor. This has been reflected in paragraph 11.15.

Under Licence condition T52.b) we have replaced the ‘/’ with ‘and’ to make clear that clinics need to screen for both HBsAg and Anti-HBc.
A link to an article on HTLV screening, issued in Clinic Focus in November 2010, has been added to ‘Other legislation, professional guidelines and information’

Guidance note 15 – Procuring, processing and transporting gametes and embryos
For partner donation only:

The guidance in ‘interpretation of mandatory requirements’ box 15D has been updated to reflect requirements of the amended European Directive which states that for donation by partners (except for IUI), blood samples must be obtained within three months before the first donation. The HFEA does not define at what point first donation begins; clinics should therefore use their professional clinical judgment to make this assessment.
This guidance also now clarifies that screening tests do not necessarily need to be repeated if patients have screening tests at one licensed clinic and then move to another if within these timescales.
For further partner donations by the same donor (person), further blood samples must be obtained according to national legislation, but no later than 24 months from the previous sampling. These screening requirements are relevant for individuals who provide gametes (their eggs, sperm or embryos) that will be processed or stored, or provided for treatment of their partner (partner donation).

The HFEA does not require centres to repeat the screening process when removing frozen gametes/embryos from storage for use in partner treatment.

15D has also been updated to clarify that a couple who are not in an intimate physical relationship should be screened in line with the non-partner donation licence condition requirements.

Clinics should use their professional judgment to consider whether further screening in accordance with professional body guidance is appropriate for couples in co-parenting situations (eg, friends who receive treatment together). In these situations, patients may be aware of any associated risks of treatment together and consider that such screening is inappropriate – in a similar way to a couple in an intimate physical relationship being aware of each other’s family history and medical conditions.

We have included licence condition T50 and T51 in this guidance note, as the patient screening requirements are relevant to processing as well as storing.

A link to an article on HTLV screening, issued in Clinic Focus in November 2010, has been added to ‘Other legislation, professional guidelines and information’.

Guidance note 17 – Storage of gametes and embryos
Under Licence condition T50.b) we have replaced the ‘/’ with ‘and’ to make clear that clinics need to screen for both HBsAg and Anti-HBc.

The guidance in interpretation of mandatory requirements box 17A has been updated with the same information in 15D in guidance note 15.

A Chair’s letter (CH(13)04) issued in December 2013 clarified the regulatory requirements for storing and using ovarian and testicular tissue. These are that HFEA licensed clinics currently storing ovarian or testicular tissue can continue to do so without an HTA licence until the tissue is to be used. These requirements have been reflected in the ‘interpretation of mandatory requirements’ box 17B.

A link to an article on HTLV screening, issued in Clinic Focus in November 2010, has been added to ‘Other legislation, professional guidelines and information’.

Guidance note 19 – Traceability
‘Possessing’ has been corrected with ‘processing’ in licence condition T101.

Guidance note 21 – Intra-cytoplasmic Sperm Injection (ICSI)
This guidance note has been updated to include an active link to Association of Clinical Embryologists (ACE) guidelines

Guidance note 22 – Research and Training
The ‘interpretation of mandatory requirements’ box 22B has been amended to clarify the point at which embryos are considered to have been ‘used in the project of research’. Embryos can be stored prior to use at a research institute and we would not consider this to mean that the embryos have been used in research. Furthermore, not all research may involve the culturing of embryos.

The Act clearly allows patients to vary or withdraw their consent to embryos being used in research up until they are ‘used for the purposes of any project of research’. It does not restrict when this can happen based on the location of the stored embryos (ie, at a research institute or treatment clinic). Where no research has been carried out, the law allows consent to be varied or withdrawn. Therefore, the definition of ‘used in the project of research’ set out in 22B has been refined to better reflect the meaning and intent of the Act, stating that ‘Embryos will be regarded as having been used in research, when any of the methods, techniques or processes associated with the particular licensed research project are applied to the embryo’.
Clinics should continue to ensure that patients are well informed about their ability to vary and withdraw consent, as well as the implications of having embryos transferred from a treatment clinic to a research institute.

SaBTO has issued a new guideline ‘Donation of Starting Material for Cell-Based Advanced Therapies: a SaBTO Review’ in June 2014 which has been linked to under ‘Other legislation, professional guidelines and information’.

Guidance note 26 – Equipment and Materials
Guidance circulated in a Clinic Focus article in April 2013 regarding the importance of using CE marked products has been reflected in paragraphs 26.3-26.5.

Guidance note 29 – Treating people fairly
Paragraph 29.8 has been included to reflect SaBTO guidance which says there should be no specific restrictions regarding donations for men who have sex with men (see update to Guidance 11 above).

Guidance note 30 – Patient confidentiality and electronic records
Guidance has been added to reflect a recent alert issued to centres about the potential for inadvertent breaches of patient confidentiality when third parties access software driven systems remotely. All staff are responsible for maintaining confidentiality, and the PR must ensure that they are satisfied with the steps taken to maintain this. Centres must be aware that the disclosure of information identifying an individual as being provided with treatment services (other than basic partner treatment services) is a breach of section 33A of the 1990 Human Fertilisation and Embryology Act (as amended) and that such breaches are an offence under the terms of section 41 (5) of the Act.

Paragraph 30.6 has been updated to remind centres that extra scrutiny is recommended if the centre has laboratory equipment which stores patient identifying information electronically and paragraph 30.7 has been added to include reasonable steps which clinics can take to mitigate the risk of inadvertent access to patient identifying information via electronic records.

Changes to General Directions

General Directions 0005 – Collecting and recording information for the Human Fertilisation Embryology Authority

The HFEA has reviewed the clinic submission timeframes for register data in response to a sector driven proposal. General Directions 0005 has been updated to reflect extended submission timeframes for all forms except ‘intention to treat’ and ‘early outcome’.

The section on donor information submission has also been updated to reflect the changes relating to legal parenthood for intended parents involved in surrogacy arrangements which came into effect on 1 October 2013. http://www.hfea.gov.uk/7962.html

General Directions 0011 – Reporting adverse incidents and near misses

Directions 0011 has been updated to inform clinics that the reporting of incidents should be directed to the ‘incidents team/inspector’ instead of the ‘Director of Compliance’.

 Annex 2: The Revision Control sheet (sets out updates in detail)

Annex 3: The updated guidance notes and directions

 Guidance notes

General Directions

Page last updated: 18 February 2015