Executive Licensing Panel - minutes · treatment (excluding partner intrauterine insemination). In relation to activity levels this is a small centre. 1.6. The panel noted that for

Executive Licensing Panel - minutes

Centre 0165 (Brentwood Fertility Centre) Interim

Friday, 17 June 2016

HFEA, 10 Spring Gardens, London SW1A 2BU

Panel members Juliet Tizzard (Chair) Joanne Anton Howard Ryan

Director of Strategy & Corporate Affairs Head of Regulatory Policy Technical Report Developer

Members of the Executive Dee Knoyle Ian Brown

Secretary Head of Corporate Governance

External adviser

Observers

Declarations of interest Members of the panel declared that they had no conflicts of interest in relation to this item.

The panel had before it: 8th edition of the HFEA Code of Practice

Standard licensing and approvals pack for committee members.

1. Consideration of application 1.1. The panel considered the papers, which included an inspection report and licensing minutes for

the last three years.

1.2. The panel noted that Brentwood Fertility Centre, centre 0165 has held a licence with the HFEA since 1998. The centre provides a full range of fertility services.

1.3. The panel noted that the centre’s licence is due to expire on 28 January 2018.

1.4. The panel noted that the inspection took place on 9 December 2015.

1.5. The panel noted that in the 12 months to 31 October 2015, the centre provided 100 cycles of treatment (excluding partner intrauterine insemination). In relation to activity levels this is a small centre.

1.6. The panel noted that for the period August 2014 to July 2015, HFEA-held register data for IVF and ICSI showed the centre’s success rates were in line with national averages.

1.7. The panel noted that in 2014, the centre reported five cycles of partner insemination with one pregnancy. This was consistent with the national average.

1.8. Between August 2014 and July 2015, the centre’s multiple pregnancy rate for all IVF, ICSI and frozen embryo transfer (FET) cycles for all age groups was 15%. This means that the centre’s multiple live birth rate is likely to meet the 10% maximum multiple live birth rate target for this period.

1.9. The panel noted that at the time of the interim inspection on 9 December 2015, seven major and two other areas of non-compliance were identified. The panel noted that some areas of concern were also identified at the last renewal inspection. The panel noted that since the inspection the Person Responsible (PR) has implemented all of the recommendations to address the non-compliances and has committed to provide a summary of follow up audits of practice where required, to ensure the effectiveness of corrective actions taken.

1.10. The panel noted that following these concerns, a management review was held in accordance with the HFEA Compliance and Enforcement Policy and the PR fully engaged with the HFEA. The PR provided a comprehensive response to the recommendations made in this report and was receptive to guidance offered.

1.11. The panel noted that there was positive feedback from patients in relation to their treatment at the centre.

1.12. The panel noted that the inspectorate recommends the continuation of the centre’s treatment and storage licence. The inspectorate also recommends that, in order to monitor the efficacy of the implementation of the recommendations made in this report, the centre will be inspected within nine months of this interim inspection.

2. Decision 2.1. The panel had regard to its decision tree.

2.2. The panel noted that the PR has fully engaged with the HFEA and addressed all of the non-compliances identified. The panel was satisfied that the centre was fit to have its treatment and storage licence continued.

2.3. The panel endorsed the inspectorate’s recommendation to carry out an inspection at the centre within nine months of this interim inspection in order to monitor the efficacy of the implementation of the recommendations made in this report.

3. Chair’s signature 3.1. I confirm this is a true and accurate record of the meeting.

Signature

Name

Juliet Tizzard

Date

30 June 2016

1 Interim inspection report, centre 0165, December 2015 Trim Reference: 2016/002367

The Human Fertilisation and Embryology Authority (HFEA) is the UK's independent regulator of the fertility sector. The HFEA licenses centres providing in vitro fertilisation (IVF) and other fertility treatments and those carrying out human embryo research. Licensed centres usually receive a licence to operate for up to four years and must, by law, be inspected every two years. The full inspection prior to a licence being granted or renewed assesses a centre’s compliance with the law and the HFEA’s Code of Practice (CoP) and Standard Licence Conditions (SLC). This is a report of a short notice interim inspection together with our assessment of the centre’s performance based on other information. We do this at the mid-point of the licence period. For 2015-2017 the focus of an interim inspection is: Quality of care: the quality of care provided by a centre is defined by positive

healthcare outcomes and a positive patient experience delivered via safe and effective care.

Patient safety: patient safety is a fundamental and essential attribute to quality healthcare: without safety there cannot be high quality. Improving safety is an ethical imperative for healthcare providers, and the individuals who deliver that care.

Patient experience: understanding what matters to patients and improving the patient experience is crucial in delivering high quality care.

We also take into account the centre’s own assessment of its service; the progress made in implementing the actions identified at the last inspection; and our on-going monitoring of the centre’s performance. The report represents a mid-term evaluation of a centre’s performance based on the above. The aim is to provide the Authority’s Executive Licensing Panel (ELP) with information on which to make a decision about the continuation of the licence.

Centre name: Brentwood Fertility Centre Centre number: 0165 Date licence issued: 29/01/2015 Licence expiry date: 28/01/2018 Additional conditions applied to this licence: None Date of inspection: 09/12/2015 Inspectors: Gill Walsh and Sara Parlett Date of Executive Licensing Panel: 17/06/2016 Purpose of the report

Interim Licensing Report


Summary for the Executive Licensing Panel The ELP is asked to note that at the time of the inspection recommendations for improvement were made in relation to seven major and two ‘other’ areas of non compliance or poor practice. Significant improvement was required in order for the centre to demonstrate suitable practices. As a result of these concerns, a management review was held in accordance with paragraph 4.6 of the HFEA Compliance and Enforcement Policy to consider the level of risk these non compliances may pose to patients and / or their gametes and embryos. In accordance with paragraph 4.2 of the HFEA’s Compliance and Enforcement policy it was agreed that informal action was warranted in the first instance if formal regulatory action was to be avoided. The ELP is also asked to note that the PR has fully engaged with the HFEA, has been receptive to guidance offered and has provided a comprehensive response to the recommendations made in this report. Since the inspection the PR has provided evidence that the following recommendations have been implemented: ‘Major’ areas of non compliance:

The PR should conduct a review of the centre’s quality management system to ensure that the scope of the audit process is robust and that corrective actions are effectively implemented.

The PR should review the process for disseminating information, guidance and actions required by the HFEA and other bodies to ensure an effective learning culture is present.

The PR should review the centre’s processes to ensure that medical records are complete and accurately reflect the patient’s medical history, assessment and the indications for treatment.

The PR should conduct a comprehensive review of the processes for assessing, screening and providing information to donors and managing donor information.

The PR should review all relevant internal consent forms to ensure that the information contained within them is accurate and reflects what is currently permitted in law.

The PR should review the written information provided to patients about treatment with intralipid, to ensure it accurately reflects the requirements of guidance and that the rationale for intralipid being prescribed ‘off label’ is fully documented.

The PR should seek independent legal advice as to whether it is considered that, albeit minor, the discrepancies notes in records seen present a risk that legal parenthood consent may not be valid. The PR should also review the process for checking consent prior to treatment to ensure that any discrepancies are corrected.

‘Other’ areas of practice that require improvement The PR should ensure that products are only used for purposes for which they are

CE marked. The PR should review the process for final review of welfare of the child assessment

forms to ensure that approval and the offer of treatment is documented accurately. The PR has given a commitment to provide a summary of follow up audits of practice where required to ensure the effectiveness of corrective actions taken.


The inspection team recommends the continuation of the centre’s licence and notes in particular the positive feedback provided by patients to the centre team regarding the care they have received. The centre’s next routine inspection is anticipated to be that for licence renewal in August 2017. In order to monitor the efficacy of the implementation of the recommendations in this report, the inspection team recommends that, at the discretion of the executive, the centre be inspected within nine months of this interim inspection.


Information about the centre Brentwood Fertility Centre is situated within the Nuffield Health Hospital, Brentwood, Essex. The centre has been licensed by the HFEA since 1998 and provides a full range of fertility services. The centre provided 100 cycles of treatment (excluding partner intrauterine insemination) in the 12 months to 31 October 2015. In relation to activity levels this is a small centre. The current licence was varied in August 2015 and again in November 2015 to reflect a change of Licence Holder. The centre was last inspected in July 2014 for licence renewal. The report of that inspection was considered by a Licence Committee (LC) on 6 November 2014. An application to reflect a change of PR was due to be considered by an ELP on 14 November 2014. This application could not be considered at the same time as the licence renewal report as the application was submitted after the renewal report was submitted to the LC. In light of this and the significant number of recommendations made within that report, the committee decided to adjourn its decision until such time as the application to appoint a new PR had been considered and written confirmation had been received from the new PR confirming that she was acceptant of the recommendations made in that report and gave commitment to their full implementation. As the centre’s licence was due to expire on 31 December 2014, the committee issued a special direction to permit the continuation of licensed activities until such time as this new information could be considered and a decision made regarding licence renewal. The centre’s current licence was subsequently granted on 29 January 2015 with no additional conditions for a period of three years, rather than the usual four. The LC also required that an interim inspection be conducted within one year of this licence coming in to force. This is the report of that inspection visit. The inspection was short notice as opposed to unannounced as activity levels at the centre are low and the inspection team wished to be assured that key personnel would be present.


Details of Inspection findings Quality of Service Each interim inspection focuses on the following themes: they are important indicators of a centre’s ability to provide high quality patient care and to meet the requirements of the law. Pregnancy outcomes1 For IVF and ICSI, HFEA held register data for the period August 2014 and July 2015 show the centre’s success rates are in line with national averages. In 2014 the centre reported five cycles of partner insemination with one pregnancy. This is consistent with the national average. Multiple births2 The single biggest risk of fertility treatment is a multiple pregnancy. Between August 2014 – July 2015, the centre’s multiple pregnancy rate for all IVF, ICSI and FET cycles for all age groups was 15%. This means that the centre’s multiple live birth rate is likely to meet the <10% multiple live birth rate target. Witnessing Good witnessing processes are vital to ensure there are no mismatches of gametes or embryos and that identification errors do not occur. There were no laboratory procedures that required witnessing to observe during the inspection. From discussions with staff and a review of recently completed witnessing records and the centre’s own witnessing audit, it is concluded that witnessing using a manual system is conducted in accordance with HFEA requirements. Consent: To the storage of cryopreserved material The storage of gametes and embryos is an important service offered by fertility clinics. It enables patients to undergo further fertility treatment without additional invasive procedures and to preserve their fertility prior to undergoing other medical treatment such as radiotherapy. It is important that the centre has measures in place to ensure that gametes and embryos are stored in accordance with the consent of the gamete providers. On inspection, reports of audits of all stored gametes and embryos and of the accuracy of storage logs and consent records were reviewed. The centre’s ‘bring-forward’ system was discussed with staff and storage records were reviewed. These activities indicate that the centre’s processes for storing gametes and embryos in line with the consent of the gamete providers are effective.

1 The data in the Register may be subject to change as errors are notified to us by clinics, or picked up through our quality management systems. Centre success rates are considered statistically different from the national averages, and multiple pregnancy rates are considered statistically different from the 10% multiple live birth rate target, when p ≤ 0.002. 2The HFEA use a conversion factor of 1.27 to convert the 10% multiple live birth rate (MLBR) target to a multiple pregnancy rate (MPR) target of 13%.


Staffing Having the right numbers of staff, competent to carry out highly technical work in a non-pressured environment is important in infertility services. The inspection team considered that staffing levels in the clinic appeared suitable for the activities being carried out: patients attending for consultations were seen promptly on arrival; the atmosphere in the clinic appeared calm at all times. Although no laboratory procedures could be observed on inspection, the senior embryologist gave assurance that he is able to carry out laboratory activities without distraction and staff competent in witnessing are available to carry out these activities when required. Quality Management System (QMS) It is important that centres audit all of their practices at least every two years to ensure they are delivering the expected quality of service, that staff are following standard operating procedures and that the centre’s processes meet the HFEA’s regulatory requirements. It is also important that these audits are robust and that any necessary changes identified are made, as this supports continuous improvement. The effectiveness of the centre’s QMS was assessed by reviewing the reports of the following audits: witnessing, traceability, consent to storage, consent to treatment and medical records. A review of the centre’s own medical records audits showed that whilst these audits were regularly being performed, the same or similar non-conformities were repeatedly identified. It was also noted that the centre’s own audits did not identify a number of documentation errors or omissions which were identified in the sample audit of patient records conducted on inspection. These are described elsewhere in this report. Such was the frequency of the errors or omissions observed in the records reviewed, the inspection team has concerns that, whilst audits are being conducted, the scope of these audits does not effectively identify areas for improvement and corrective actions are not robust (recommendation 1). We also considered whether the clinic’s processes for implementing learning are effective. If a clinic is to achieve continuous improvement and encourage a learning culture then it is important that they act to review their practices when guidance is issued by the HFEA or other bodies. The clinic’s procedures for acting on guidance from the HFEA were evaluated with reference to the following:

the content of the centre’s website - Chair’s letter CH(11)02 the use of the most recently issued HFEA consent form versions - Chair’s letter

CH(15)01 the centre’s audit of legal parenthood - Chief Executive’s letter CE(14)01 HFEA Clinic Focus articles regarding:

o the use of CE marked devices (April 2013) o screening requirements (March 2013) o handling donor information – best practice guide (March 2015) o prescribing intralipid and the information provided to patients (July 2015)

Significant improvements are required for the centre to demonstrate a fully effective learning culture because the centre had not ensured compliance with guidance, as described in the body of this report (recommendations 2, 4, 6 and 8).


Medicines management It is important that clinics follow best practice for medicines management to protect patients and ensure that medicines are stored, administered and disposed of in the correct way. During the inspection, the clinic’s processes for medicines management and the safe storage, disposal and administration of medicines were reviewed and were found to be compliant with the exception noted below regarding the use of intralipid. Prescription of intralipid ‘off label’ Intralipid is a sterile liquid soybean and egg yolk based fat emulsion which is licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA) as an intravenous nutritional supplement for adults and children. Some healthcare professionals consider intralipid therapy has an effect on the immune system and may be beneficial to a particular subset of women having IVF. Intralipid is not licensed for use in fertility treatment. If prescribed in this context, this represents ‘off-label’ use. Healthcare professionals’ responsibilities when prescribing a medicine off-label may be greater than when prescribing a medicine for use within the terms of its licence. In April 2015 the President of the Royal College of Obstetricians and Gynaecologists (RCOG), published concerns regarding the evidence base for the use of intralipid in IVF in terms of its safety and efficacy. In July 2015 the HFEA published guidance to centres regarding the prescribing of intralipid or other ‘off label’ therapies to patients. This guidance required centres to take responsibility for prescribing the medicine and for overseeing the patient’s care by:

reviewing and recording the information provided to patients about intralipid therapy to ensure that the reasons for prescribing it ‘off-label’ are explained, including that there is currently little evidence to support its use in this application;

recording the reasons for prescribing intralipid in the patient’s records and; ensuring that patients who are prescribed intralipid are properly monitored and

followed up. The process for administering and monitoring patients during intalipid infusion was reviewed and considered to be suitable. Written information provided to patients offered intralipid states that it is prescribed ‘off-label’ and that ‘some research’ indicates treatment with intralipid may be beneficial. However the rationale for prescribing intralipid, when there is currently little evidence to support its use is not explained. No record of the information provided is made the patient’s notes. The rationale for intralipid therapy as documented in patient records by the prescribing clinician is ‘previous failed treatment’ which the inspection team does not consider to be a suitably detailed rationale (recommendation 6). Infection Control It is important that clinics have suitable arrangements in place so that patients experience care in a clean environment and to prevent patients and staff acquiring infections.


During the inspection, we reviewed infection control practices and found them to be compliant with guidance. Equipment and Materials It is important that products (known as medical devices) that come into contact with gametes and/or embryos are approved for the provision of fertility treatment, to ensure the safety of gametes, embryos and patients. The approval of such products is denoted by the issue of a ‘CE mark’. The CE mark status of medical devices was reviewed in the course of the inspection. The centre uses a solution as a flushing agent during egg collection that is not CE marked for this use (recommendation 8). Patient experience During the inspection, no patients were available to speak with the inspectors about their experiences at the centre. No patients have provided feedback directly to the HFEA in the time since the last inspection. The centre’s own mechanism for obtaining patient feedback was discussed and reviewed on inspection. Patients who provided feedback on the care they received at the centre were very positive about their experiences. On the basis of this and observations made in the course of the inspection, it was possible to assess that the centre:

has respect for the privacy and confidentiality of patients in the clinic; provides a clean and well organised environment for patient treatment; has staff who are supportive and professional; maintains an effective system for responding to patient phone calls.

Monitoring of the centre’s performance

In addition to commenting on evidence gathered on the inspection it is important to report on the centre’s performance since the granting of the licence based on other evidence available to us. Compliance with HFEA standard licence conditions From a review of 10 patient and donor records, the inspection team identified the following non-compliances: 1. In the majority of records seen, the patient’s unique identifier (e.g.: NHS or passport

number) has not been recorded on the HFEA consent forms (recommendation 3).

2. The centre is not using the most current version of HFEA consent forms as required from 1 April 2015 (recommendation 2).

3. HFEA consent forms require patients to sign and date a declaration on each page to

confirm they have read the page and fully agree with the consent and information given.


In one record the patient had not dated and signed the page declaration on three pages of her consent to disclosure form (recommendation 3).

4. One patient file reviewed showed that:

I. The patient is a single woman who received treatment with donor sperm. Information in correspondence from the treating clinician to the patient’s GP did not correspond with the patient’s medical history, indication for treatment or personal circumstances. One letter made reference to the clinician’s consultation with a heterosexual couple (both of whom were referred to by their first name), whilst a second letter referred to a consultation with ‘this same sex couple’, in each case the indication for treatment was different.

II. It was unclear whether this patient had been treated with a partner or not. When asked how she was assured that the patient treated was a single woman, the PR responded that she knew the patient well. To provide further reassurance the PR contacted the treating clinician who confirmed that the patient is single and that the discrepancies in the correspondence to the GP must be dictation transcription errors. Where the couple was named in the correspondence, the clinician explained that he has another patient with the same first name who does have a partner and this too must be a clerical error.

Whilst it is acknowledged that the PR was able to provided first hand knowledge of this patient, the inspection team considers that the inaccuracies found in this patient’s record could have posed a risk of failing to readily identify where a partner welfare of the child assessment should be in place or where legal parenthood consent may be required (recommendation 3 and 9).

5. For one patient who was treated with the gametes of a donor known to her, the donor

had not been screened for gonorrhoea (recommendation 4).

6. In a separate instance where the donor was known to the recipient, the donor’s record showed:

I. Donor screening was performed overseas. The testing laboratory results were not in English but were decipherable for karyotyping and cystic fibrosis screening. The result of the donor’s viral screening was provided in an email written by the donor. It was unclear from the donor’s email whether she had been screened for syphilis. Following the inspection the PR was able to provide a copy of the testing laboratory report which showed a negative result for syphilis and confirmed a negative test for all other screening. The PR could not confirm the accreditation status of the testing laboratory (recommendation 4).

II. There was no evidence of a donor health questionnaire or medical history in the donor’s record. The only entry made and signed by the treating clinician stating the date of egg collection and the number of eggs collected. The inspection team does not consider this constitutes a documented record of donor assessment and her medical history. It is of note that this was of concern at the last inspection. See recommendations 3 and 4.

7. The following non-compliances relating to welfare of the child (WoC) assessment were

noted: I. There was no evidence that the WoC forms for one couple treated had been

reviewed and they were not signed off as approved for treatment;


II. For two sets of records, in the section of the WoC form to be completed by the centre, ‘no’ to treatment offered had been ticked however treatment was provided. The ‘no’ to treatment offered was not qualified by a comment in either case, both WoC forms had been signed by a centre ‘approver’. See recommendation 9.

8. In one egg share donor record:

I. The donor’s WD (female donation consent) form shows she consented to embryos created with her eggs being stored for five years and that she did not consent to the use of those embryos in the event she should die or become mentally incapacitated. The PR could not confirm that these consent decisions were explained to the recipient of the donated eggs and that they would be relevant if she wished to store embryos created with the donor’s eggs. In the event that embryos created were stored, there was no account of how, should the donor die or become mentality incapacitated, the recipient would be made aware of this and the donor’s consent wishes be invoked. As the WD consent wishes provided by the egg share donor mirrored that provided in her own treatment and storage WT form and that of her partner’s MT form, the inspection team has concerns that the egg share provider did not fully understand the implications of her WD consent restrictions.

II. The third and fourth pages of the HFEA donor information form were missing from the donor’s record therefore there was not evidence of the donor providing a ‘pen portrait’ or any good will message. The PR explained these pages had been detached and perhaps given to the donor but that she had not returned them. The PR was reminded that she should provide a copy of the entire donor information document to the HFEA as a complete record, irrespective of whether the donor has chosen to complete these sections. From discussion with the PR there appeared to be some confusion about the importance of encouraging any donor to complete a pen portrait and good will message.

It was noted that, although the timeliness of screening seen in donor records reviewed was acceptable as it was within the timeframes specified for donation by the Authority, the PR appeared not to consider it necessary to make any differentiation between the timeframes for screening for patients and donors. See recommendations 2, 4 and 5.

Compliance with recommendations made at the time of the last inspection Following the renewal inspection in July 2014, recommendations for improvement were made in relation to one critical, seven major and six ‘other’ areas of non-compliance. Following the inspection confirmation was provided that recommendations relating to the critical area of non-compliance and two ‘other’ areas of non-compliance had been fully implemented. The PR subsequently provided information and evidence that all of the recommendations were implemented within the required timescales.


On-going monitoring of centre success rates Since the last renewal inspection in July 2014 the centre has not received any performance related risk tool alerts. Provision of information to the HFEA Clinics are required by law to provide information to the HFEA about all licensed fertility treatments they carry out. This information is held in the HFEA Register. The clinic is compliant with requirements to submit information to the HFEA. Legal parenthood Where a couple to be treated with donated gametes or embryos is not married or in a civil partnership, both the woman and her partner must give written consent in order for the partner to become the legal parent of any child born. If this consent is not documented properly or if proper information is not provided or counselling offered prior to both parties giving consent, there may be doubt about the effectiveness of the consent and in some cases it may be necessary for a patient couple to obtain a court declaration to establish legal parenthood. In February 2014, the HFEA asked all centres to audit their practices in this area to ensure they are suitable, to report the findings of the audit to the HFEA and to respond to those findings. The centre provided the report of the audit to the HFEA within the required timeframe and took appropriate action with respect to the issues identified by the audit. The centre’s legal parenthood audit was reviewed at the renewal inspection conducted in July 2014, this showed that the audit had been performed according to the method specified by the HFEA and that actions had been taken in response to the audit findings. Two anomalies were noted in that audit which have subsequently been investigated by the PR in post at the time and have been satisfactorily resolved. Since that inspection a different PR has been appointed. As part of the HFEA’s ongoing activities relating to ‘legal parenthood’, in October 2015 all PRs were asked to confirm that specific actions had been undertaken; that there are effective methods for assessing the on-going competence of staff to take this consent; and that effective audit procedures to ensure on-going compliance with consent taking requirements are in place. The current PR provided confirmation of this. To provide further assurance of the effectiveness of the centre’s procedures, the inspection team reviewed three sets of records where treatment with donor sperm had recently been provided in circumstances where consent to legal parenthood may be required. Whilst there is currently no concern regarding legal parenthood consent being effectively in place, the following points were noted:

The marital or civil partnership status of couples being treated with donor gametes or embryos could not readily be established as this is not specifically documented in all patient records. Whilst the PR could provide assurance of the marital or civil partner status in each case, as she knew the couples individually, in the event that this tacit


information was not available, there is a risk that the requirement for legal parenthood consent could be missed and that the centre’s audit processes would not be robust.

Sections 1.4 and 2.4 (recording the NHS or other unique identifying number) in both WP and PP forms was not completed for one couple; this omission was noted in other consent records (not consent to legal parenthood) reviewed.

In one record, correspondence referred to the patient’s husband however the male signed ‘I am the partner of [patient’s name] and I agree by signing HFEA PP form to be legal parent’ but did not complete the husband section of the centre’s internal legal parenthood consent form; therefore it was not clear whether the couple were married or not.

In WP and PP forms for one couple it was noted that the partner’s surname was spelt slightly differently on one form from the other.

(Recommendation 7).

7 Interim inspection report, centre 0165 9 December 2015 Trim Reference: 2016/002367

Annex 1 Areas of practice that require the attention of the Person Responsible The section sets out matters which the Inspection Team considers may constitute areas of non compliance. These have been classified into critical, major and others. Each area of non compliance is referenced to the relevant sections of the Acts, Regulations, Standard Licence Conditions, Directions or the Code of Practice, and the recommended improvement actions required are given, as well as the timescales in which these improvements should be carried out.

► Critical areas of non compliance A critical area of non compliance is an area of practice which poses a significant risk of causing harm to a patient, donor, embryo or child who may be born as a result of treatment services. A critical area of non compliance requires immediate action to be taken by the Person Responsible.

Area of practice and reference Action required and timescale for action

PR Response Inspection team’s response to the PR’s statement

None identified


► ‘Major’ area of non compliance A major area of non compliance is a non critical area of non compliance:

which poses an indirect risk to the safety of a patient, donor, embryo or child who may be born as a result of treatment services;

which indicates a major shortcoming from the statutory requirements; which indicates a failure of the Person Responsible to carry out his/her legal duties; which can comprise a combination of several ‘other’ areas of non compliance, none of which on their own may be

major but which together may represent a major area of non compliance.

Area of practice and reference

Action required and timescale for action

PR Response Inspection team’s response to the PR’s statement

1. The Quality Management System – audit and implementation of corrective actions

The centre’s own audit practices have in some instances failed to identify significant areas of non compliance or poor practice, as described in the body of this report. Where the centre’s audits have identified issues, the centre has not implemented robust corrective or preventative actions as the errors identified have recurred,

The PR should conduct a review of the centre’s quality management system to ensure that the scope of the audit process is robust and that audits are performed against all regulatory requirements. The PR should also investigate where there may be barriers to learning from audits performed to ensure that corrective actions are effectively implemented. The outcome of the review and an action plan with timescales for the implementation of any changes should be provided to

Audit forms reviewed to assess the information being captured and disseminated to all of the team. Following the inspection, we are going to audit all of the notes from cycles carried out each month instead of just a few. Repeat competencies for all staff looking at and signing off on welfare of child consents. At the HFEAs suggestion, we are going to implement the forms relating to Record of information provided before obtaining consent for the male and female and we have

The executive acknowledges the PR’s response and receipt of documentation to demonstrate actions taken to implement this recommendation. No further action is required. A review of a selection of audits since the time of this inspection will form part of the next inspection.


with particular reference to welfare of the child, consent (including consent to disclosure) and medical records. SLC T36

the centre’s inspector by 9 April 2016.

revised our Consent for IVF,ICSI, Blastocyst and ET so that it only states correct facts (attachment 1 and 1.2 saved only for the purpose of this reply and attachment 1.3 is our internal consent form)

2. The Quality Management System: implementation of guidance and learning

The PR has not implemented guidance provided by the HFEA or other bodies, as described in the body of this report.

The PR should review the process for disseminating information, guidance and actions required by the HFEA and other bodies, to ensure that those affected by or required to take action as a result of these requirements, are aware of their roles and responsibilities in this regard in order for effective learning to be demonstrated. As part of that review the PR should consider, where staff had been informed of the required change and action required but this has not been effective, what is the root cause of this failing. The PR should provide a

The HFEA clinical focus are attched to the minutes of our monthly meetings along with any alerts from the Hospital regarding new policies etc. The minutes are sent out to all members of the team including clinicians and a read reciept is now required. Also, once they respond that they have read the document, there is an acknowledgement table for the PR only to record this on. (attachment 2) There is now an action plan at the beginning of each unit meeting to assess any issues that arose after the last meeting and discuss corrective actions to prevent reoccurrence. (attachment 3)

The executive acknowledges the PR’s response and receipt of documentation to demonstrate actions taken to implement this recommendation. No further action is required. A review of the implementation of guidance and learning since this inspection, will form part of the next inspection.


summary of this review and details of any actions taken as a result, to the centre’s inspector by 9 April 2016.

3. Medical records A review of patient and donor records showed that: one patient file contained

correspondence that did not reflect the patient’s own medical and personal history;

one donor’s file did not contain any evidence of her assessment or medical history;

the unique identify such as the NHS or passport number commonly is not recorded on HFEA consent forms;

the signed declaration was missing from a number of pages of one patient’s consent to disclosure form

SLC T37, General Directions 00012 and T46 (d)

The PR should review the centre’s processes to ensure: information contained

within the patient record is accurate;

proper records of the patient or donor’s medical history and assessment a recorded;

all required fields of official documentation such as HFEA consent forms are completed.

The PR should provide a copy of the review and details of the actions in response to that review by 9 April 2016. Three months after the implementation of any corrective actions the PR should conduct a comprehensive audit of

All consent forms can only be accessed on the HFEA web site. This ensures that we are only using the latest version thereby removing the risk of using out of date consent forms. Re-training given to all staff on where they are on the website and not to photocopy any documents or forms to abide with version control. The audit process has been changed to reflect that the correct information on the consent forms regarding NHS numbers or passport numbers being missed on the documentation. Staff have been reminded during unit meetings that we have to be rigourous with asking for these details and follow up when they are missing so that it does

The executive acknowledges the PR’s response and receipt of documentation to demonstrate actions taken to implement this recommendation. A summary of the scheduled records audit should be provided to the centre’s inspector by 9 September 2016.


medical records in order to determine whether these actions are effective. The PR should provide a summary of the audit to the centre’s inspector by 9 September 2016. The PR should conduct an investigation into the circumstances which led to a number of serious transcription errors being made in correspondence to a patient’s GP and how this incorrect correspondence was subsequently including in the patient record without the errors being noted and corrective action taken. The PR should also investigate the reasons as to why a proper record was not made by the treating clinician. The PR should provide a copy of the investigations and detail of any corrective actions implemented by 9 April 2016.

not result in a non conformity being raised. (attachment 4 Medical records and attachment 5 Consent for Treatment audit tools) With regards to donors coming from abroad to donate eggs to their sister, a new check list has been written and the SOP we hold has been revisited to reflect the need to check the standard of the laboratory carrying out the blood tests conforms to UK standards and confirming the patients history is completed by email. If there are language barriers regarding the laboratory quality, then we will insist on the patient having all their screening in the UK at a quality approved laboratory.(attachment 6) In regards to the circumstances which led to a number of serious transcription errors we have made the


following changes to prevent these errors from reoccuring - 1. We have now ammended our Patient Registration form to enforce all patients must complete 'maritial status' section inline with HFEA requirements. 2. We have also added this as a double check for nurses on ALL the treatment checklists (attachments 7, 8, 9, 10) 3. We have also changed the wording of our initial consultation letters that our patients receive to enforce the importance of completing all relevant forms and bring along to their first appointment, and the letters now state that treatment will not go ahead until this criteria is met. (attachment 11) 4. Medical records audit tool revisted to include a section to check correspondence letters match patients registration form which would have been completed by the patient at/before inital consultation.


(attachment 4 as above)

4. Screening and assessment of donors and management of donor information.

A review of donor records showed there are failings in the centre’s procedures for donor screening and assessment and the management of donor information as described in the body of this report. SLC T52, T53, Handling donor information – a best practice guide for clinics (HFEA, March 2015).

The PR should conduct a comprehensive review of the process for assessing, screening and providing information to donors. In order for that review to be robust and have best effect, the PR should seek guidance from a suitably qualified person experienced in donor assessment and the provision of information to donors, to establish proper procedures and training of staff in the assessment, screening and provision of proper information to donors. The PR should provide an action plan as to how this is to be achieved and likely timescales for conducting this review when responding to this report. Following a review of practice and training, a documented

All nurses to visit Woking and Glasgow ACS to spend time with allocated nurses to improve understanding of processes. Treatment checklist amended along with the SOP for donor screening (attachment 9 as above) Welfare of the Child and Donor recruitment Competency revised (attachment 12)

The executive acknowledges the PR’s response and receipt of documentation to demonstrate actions to implement this recommendation. The executive also acknowledges the PR’s pro-active response in seeking to work with other, more experienced teams. A summary of the scheduled audit should be provided to the centre’s inspector by 9 September 2016.


assessment of competence to assess, screen, provide information and seek informed consent from donors, should be conducted for all relevant staff including treating clinicians responsible for donors. The PR should provide a copy of the review with details of actions taken and staff assessed, to the centre’s inspector by 9 June 2016. Three months after the implementation of this recommendation, the PR should conduct a detailed audit of all donor records to determine whether these actions are effective. A copy of the audit should be provided to the centre’s inspector by 9 September 2016.

5. Provision of information The centre’s own internal consent forms provide incorrect information regarding

The PR should review all relevant internal consent forms to ensure that the information contained within them is

The consent form for treatment and for embryo freezing have been changed to reflect the law. These were changed the

The executive acknowledges the PR’s response and receipt of documentation to demonstrate actions take to


the permitted period for which embryos may be stored, which may be misleading to those considering storage. Schedule 3, 3(b) of the HFE Act 1990 (as amended) SLC T58 and T59

accurate and reflects what is currently permitted in law. Copies of the revised documents should be provided to the centre’s inspector by 9 April 2016. The PR should review the process by which the centre takes account of the information provided to patients and donors to ensure that this information is current and, for reference, a record is made of what information has been provided. The PR should consider the guidance provided in Chair’s letter CH(15)01, including that which relates to information and consent to storage and extended storage of gametes and embryos. The PR should provide a copy of that review and detail of any actions taken as a result, to the centre’s inspector by 9 April

day after the inspection and are in the attachments Audit tool changed to collect the information regarding storage of embryos and to confirm the male and female consents are the same (attachment 5 as above)

implement this recommendation. No further action is required.


2016.

6. Intralipid Written information provided to patients offered intralipid states that it is prescribed ‘off-label’ and that ‘some research’ indicates treatment with intralipid may be beneficial, however the rationale for prescribing iIntralipid, where there is currently little evidence to support it’s use, is not explained. No record is made in the patient’s record of the information provided. The rationale for intralipid therapy as documented in patient records by the prescribing clinician is ‘previous failed treatment’. (Clinic focus July 2016)

The PR should review the written information provided to patients about intralipid to ensure it accurately reflects the requirements of guidance. The PR should take steps to that ensure the rationale for it being prescribed is fully documented. The PR should provide detail of the actions taken to ensure this recommendation is implemented and a copy of the revised patient information to the centre’s inspector by 9 April 2016.

The information for the patient has been changed to reflect the lack of research to say it has any benefits, and requires the patient to sign that they understand that it is off license and is not research based. This HFEA clinic focus regarding Intralipids was sent to all members of the team, including clinicians, on 7th September which was the first meeting after the summer break (attachment 13 & 14)

The executive acknowledges the PR’s response and receipt of documentation to demonstrate actions taken to implement this recommendation. A review of patient records where intralipid therapy has been provided will form part of the next inspection.

7. Legal parenthood Discrepancies were noted in a number of legal parenthood consent records reviewed on

The PR should seek independent legal advice as to whether it is considered that, albeit minor, the discrepancies notes in records seen present

Following a conversation with our corporate lawyer, they are reassured that there are no potential legal parentage issues as this particular patient

The executive acknowledges the PR’s response and receipt of documentation to demonstrate actions taken to implement this


inspection. The marital or civil partnership status of couples being treated with donor gametes or embryos could not readily determined from records and therefore where legal parenthood consent may be required was not immediately apparent. This could present a risk at that the requirement for legal parenthood may be missed or at least the audit process not being robust.

a risk that legal parenthood consent may not be valid. The PR should provide the centre’s inspector with the outcome of that advice The PR should review the process for checking consent forms prior to treatment to ensure that any anomalies are identified in good time and are corrected. The PR should also consider how information provided by the patient and her partner regarding their marital or civil partnership status could be recorded in order that this information is readily accessible to a person conducting an audit of treatments for which legal parenthood applies or during an HFEA inspection. The outcome of that review and any action taken should be

did not achieve a pregnancy. However, it has been noted that the patient must date and complete the section in the registarion form pertaining to her marital status Marriage certificate must be requested if their passport is in their maiden name. The current registration form that is being used for all new patients asks for them to describe their marital status. The case in question had not completed this part of the form which led to the confusion. (attachment 15). Also donor/legal parenthood audit tool reviewed to make sure this is clear and and the HFEA donor information form has been fully completed

recommendation. A review of patient and partner registration forms for marital or civil partnership status and legal parenthood consent forms will form part of the next inspection.


provided to the centre’s inspector by 9 April 2016. The PR should inform the centre’s inspector of any actions taken by 9 April 2016.

(attachment 16)


► ‘Other’ areas of practice that requires improvement Areas of practice that require improvement are any area of practice in which failings occur, which cannot be classified as either a critical or major area of non compliance, but which indicate a departure from statutory requirements or good practice.

Area of practice and reference Action required and

timescale for action PR Response Inspection team’s response to

the PR’s statement 8. Use of CE marked

products The centre is using Hartmann’s solution as a flush solution during egg collection. This solution is not CE marked for this use. SLC T30; CoP guidance 26.4

The PR should ensure that products are only used in applications for which they are CE marked. The PR should inform the centre’s inspector when an alternative flush solution which is CE marked for this use has been sourced. This should be no later than 9 June 2016.

We have now sourced and ordered CE marked oocyte retrieval media. We will start using this for our next cases in March 2016.

The executive acknowledges the PR’s response and actions taken to implement this recommendation. No further action is required.

9. Welfare of the child In several records reviewed there were significant documentation errors noted on the WoC assessment forms. These documentation errors were repeatedly noted in the centre’s own audit but corrective actions have not been effective. CoP guidance 18.8.

The PR should review the process for final assessment of the welfare of the child forms to ensure that a proper review is made and that the offer of treatment is documented accurately. The PR should provide a copy of this review and details of

Internal WOC SOP reviewed (attachment 17) Retraining for all staff and renew competencies. WOC Competency form has been revisited (attachment 12 as above)

The executive acknowledges the PR’s response and receipt of documentation to demonstrate actions taken to implement this recommendation. The summary of the scheduled audit should be provided to the centre’s inspector by 9 September 2016.


actions taken as a result to the centre’s inspector by 9 April 2016. Three months after the implementation of any corrective actions, the PR should conduct an audit of welfare of the child forms to determine whether these actions have been effective. A summary of the audit is to be provided to the centre’s inspector by 9 September 2016.


Additional information from the Person Responsible Attachments - 1 - Record of information provided before consent - Female 1.2 - Record of information provided before consent - Male 1.3 - Consent to IVF/ICSI/Blast/ET (internal) 2 - Unit meeting Acknowledgement table 3 - Unit meeting template 4 - Medical records audit tool 5 - Consent to Treatment audit tool 6 -Donor egg sharer from abroad treatment checklist 7 - IVF/ICSI Treatment checklist 8 - IUI Treatment checklist 9 - Egg share donor Treatment checklist 10 - Egg share recipient Treatment checklist 11 - Copy of new/initial consultation apointment letter 12 - WOC and donor recruitment staff Competency 13 - Intralipids - Patient information 14 - Intralipids - Ward information 15 - Patient registration form 16 - Donor / Legal parenthood audit tool 17 - WOC SOP

Documents

Executive Licensing Panel - minutes · treatment (excluding partner intrauterine insemination). In relation to activity levels this is a small centre. 1.6. The panel noted that for