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Interim Inspection Report

Chelsea and Westminster Assisted Conception Unit 0158

Date of Inspection: 5th September 2006 Date of Licence Committee: 30th October 2006

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CENTRE DETAILS Centre Address Chelsea and Westminster Hospital

369 Fulham Road London SW10 9NH

Telephone Number 0208 746 8585

Type of Inspection

Interim Treatment and Storage

Person Responsible

Mr Julian Norman-Taylor

Nominal Licensee

Kathryn Mangold

Licence Number

L0158/8/a

Inspector(s) Miss Sarah Hopper (Lead) Mr Parvez Qureshi Dr Debra Bloor

Observers Council on Human Reproductive Technology, Hong Kong

Professor Ho Dr Kwong

Fee Paid - date Not applicable – interim inspection

Licence expiry date

31/11/08

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Index Page Centre details ........................................................................................................................... Index ......................................................................................................................................... About the Inspection ............................................................................................................... Brief Description, Activities Summary & Risk Assessment................................................. Evaluation & Judgement ......................................................................................................... Breaches, Non-compliance Records, Proposed Licence..................................................... Changes/Improvements, Additional Licence Committees ................................................... Organisation............................................................................................................................. Quality of Service .................................................................................................................... Premises and Equipment ........................................................................................................ Information ............................................................................................................................... Laboratory and Clinical Practice ............................................................................................ Appendix A............................................................................................................................... Appendix B............................................................................................................................... Appendix C............................................................................................................................... Feedback Form ........................................................................................................................

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About the Inspection: This inspection visit was carried out on 5th September 2006 and lasted for 7 hours. The report covers the pre-inspection analysis, the visit and information received between May 2005 and September 2006. The purpose of the inspection is to ensure that centres are providing a quality service for patients in compliance with the HF&E Act 1990, Code of Practice and to ensure that centres are working towards compliance with the EU Tissue and Cells Directive 2004/23/EC. Inspections are always carried out when a licence is due for renewal although other visits can be made in between. The report summarises the findings of the interim inspection highlighting areas of good practice, as well as areas where further improvement is required to improve patient services and meet regulatory requirements. It is primarily written for the Licence Committee who make the decision about the centre’s licence renewal application. The report is also available to patients and the public following the Licence Committee meeting. At the visit the inspection team assesses the effectiveness of the centre through five topics. These are: How well the centre is organised The quality of the service for patients and donors The premises and equipment Information provided to patients and to the HFEA The clinical and laboratory processes and competence of staff. An evaluation is given at the end of each topic and for the overall effectiveness of the centre: No Improvements Required – given to centres where there are no Code of Practice, legal requirements, recommendations or conditions that need to be imposed. Some Improvements Required – given to centres that are generally satisfactory but with areas that need attention. Recommendations will usually be made to help Persons Responsible to improve the service. Significant Improvements Required – given to centres that have considerable scope for improvement and have unacceptable outcomes in at least one area, causing concern sufficient to necessitate an immediate action plan or conditions put on the Licence. The report includes a response form for the Person Responsible to complete following the inspection. The HFEA welcomes comments from patients and donors, past and present, on the quality of the service received. A questionnaire for patients can be found on the HFEA website www.hfea.gov.uk .

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Brief Description of the Centre and Person Responsible The Assisted Conception Unit at Chelsea and Westminster Hospital has been operating as an HFEA licensed centre since 1995. It performs around 300 licensed cycles a year and also offers unlicensed treatments including ovulation induction and IUI. NHS and private patients are treated and a satellite service is also provided for The Chiltern Hospital Fertility Unit (Centre 0064). The centre is located on the fourth floor of the Chelsea and Westminster Hospital. It comprises of a waiting room, which is shared with patients attending private outpatient sessions, three consulting rooms, scanning room, men’s production room, treatment room, recovery room and the laboratory. Counselling sessions are typically held off-site although in rare cases they may be conducted within one of the consulting rooms. There is a business plan in development to reconfigure the premises. It is planned that the egg collections would be performed in the day treatment centre of the hospital as this will allow for egg collections under general anaesthetic when indicated and will provide more comfortable recovery for the patients. Services are provided to patients throughout Monday-Friday and from 9am-12pm on Saturdays. Julian Norman-Taylor was approved as the PR for the centre in October 2005. He replaced Carole Gilling-Smith who had resigned from the position in September of that year. Mr Norman-Taylor attends the centre every day apart from three afternoons when he provides the accredited consultant services at the Chiltern Hospital Fertility Services Unit, BMI Chiltern Hospital (Centre 0064). Activities of the Centre

01/05/05—1/05/06

Licensed treatment cycles

IVF ICSI FET Egg sharing Egg donation (non egg-share)

135 101 26 1 4

Donor Insemination � 23

Unlicensed treatments � Cycle tracking, Ovulation

induction and IUI

Research Licence for R0150 is not being renewed

Storage �

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Summary for Licence Committee A number of regulatory issues were identified in the course of the inspection and these are summarised as follows: • During 2005 five 3 embryo transfers were performed on patients under 40 years old. This

is non-compliance with part 8.20i of the Code of Practice. • In two records belonging to patients who had received 3 embryos during transfer events,

there was no evidence in the patient records of discussion of the reasons for the multiple transfer or of the associated risks. This is a breach of Directions D2004/2 and non-compliance with the Code of Practice part 8.19.

• There is no adequate spare storage space/or vessels to enable transfer of samples in the event of a vessel failure. This is an expectation of Chairs’ letter CH (04)03

• An adverse event had occurred at the centre but had not been reported as an adverse incident to the HFEA. This is non-compliance with part 2.23 of the Code of Practice.

A number of recommendations have also been made by the inspectorate in the areas of Information, Quality of Service and Scientific and Clinical Practice. The centre should address these issues as outlined in the report. The inspection team support the continuation of the centre’s licence. Risk Assessment On the last completed risk tool the centre scored 21%.

Overall judgement of the effectiveness of the centre No Improvements required Some Improvement

required Significant Improvement required

X Evaluations from the inspection Topic No

Improvements required

Some Improvement required

Significant Improvement required

1. Organisation X 2. Quality of the service X 3. Premises and Equipment X 4. Information X 5. Laboratory and clinical processes X

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Breaches of the Act or Code of Practice Breach Action required Time scale During 2005, five 3 embryo transfers were performed on patients under 40 years old. This is non-compliance with CoP 8.20i. This non-compliance was also noted during the last inspection of the centre in May 2005. In two records belonging to patients who had received 3 embryos during one transfer event there was no evidence of discussion of the reasons for the multiple transfer or of the associated risks. This is a breach of Directions D2004/2 and non-compliance with Code of Practice part 8.19. There is no adequate spare storage space/or vessels to enable transfer of samples in the event of a vessel failure. This is an expectation of CH (04)03.

Ensure compliance with Code of Practice part 8.20i. Ensure compliance with Directions 2004/2 and Code of Practice part 8.19. Discussions with patients regarding the reasons for number of embryos transferred and risks should be documented in patient records. Contingency arrangements for dewar failure should be considered by the PR and submitted to the HFEA.

Immediately Immediately Within 3 months of consideration of the report by a Licence Committee

Non-Compliance Area for improvement Action required Time scale An adverse event had occurred at the centre but had not been reported as an adverse incident to the HFEA.

Centre should comply with Code of Practice part 2.23 which states that centres must report all adverse incidents occurring at the treatment centre within 12 working hours of the identification of the incident and submit an incident report form within 24 working hours.

Immediately

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Recommendations Time scale Development of written protocols on confidentiality, witnessing procedures, response to damaged storage vessels, cleaning/filling/securing of dewars, management for gametes and embryos in storage and for the maintenance and servicing of equipment.

Within 6 months of consideration of the report by a Licence Committee

Laboratory staff should consider participation in the United Kingdom National External Quality Assessment Service (NEQAS) andrology scheme

Within 6 months of consideration of the report by a Licence Committee

The low patient uptake of counselling should be investigated and monitored.

Within 6 months of consideration of the report by a Licence Committee

A protocol for response to dewar failure and low oxygen alarm should be created

Within 3 months of consideration of the report by a Licence Committee

Patient and donor information should be updated as suggested by the Inspectorate

Within 3 months of consideration of the report by a Licence Committee

A documented training programme for all staff should be developed.

Within 6 months of consideration of the report by a Licence Committee

The senior embryologist should assess whether the current system for responding to a dewar alarm carries any associated risk

Within 3 months of consideration of the report by a Licence Committee.

Proposed licence variations N/A N/A

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Changes/ improvements since last inspection Recommendation Action taken The centre needs to have the ability to demonstrate continuing professional development for all staff including counselling staff and nurses

A training log has been created for new clinicians and documentation of training of embryologists was evidenced during the inspection. A number of nurses had evidence of CPD in their training files though this was not universally the case.

The PR must demonstrate that the centre complies with all the conditions of its HFEA licence by providing relevant data regarding licensed treatments

Data no longer required for interim/renewal applications so this recommendation could not be assessed.

The centre needs to develop protocols for cleaning, filling and securing vessels and the handling of contaminated samples

Protocol has not yet been developed.

The previous inspectorate advised that alarms should be fitted to the dewars and an autodialler facility should be setup in the infectious diseases laboratory

Alarms and autodiallers have been fitted.

Additional licence conditions and actions taken by centre since last inspection C N/A

A Complied Y/N

C N/A

A Complied Y/N

C N/A

A Complied Y/N

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Report of Inspection findings 1. Organisation

Desired Outcome: The centre is well-organised and managed and complies with the requirements of the HFE Act.

Summary of findings from inspection Evidence is drawn from: � Leadership and management � Organisation of the centre � Resource management � Risk management � Incident management � Contingency arrangements � Business planning � Clinical governance � Payment of treatment fees

Areas of firm compliance The Inspectorate agreed that the centre appeared to be well organised. Multi-disciplinary meetings and educational meetings are held once a month. In addition to these, team meetings are held every alternate week. Evidence of team meetings was provided to the inspectorate; a team meeting book is maintained which ensures that key decisions about the centre’s service can be disseminated to all staff including those absent from meetings. The PR is aware of the requirements of the EUTD and has attended the BFS workshop on Quality Management Systems. A quality manager has been appointed from the internal team and her training will include attendance at the BFS Quality Management systems workshop. Steps have also been taken towards ISO 9001 accreditation and an ISO consultant has been selected to act as an advisor for this project. Contingency arrangements are in place to ensure that the workload in the laboratory can be maintained in the event that numbers of staff are reduced. These arrangements have proved effective in the last 12 months whilst the Senior Embryologist was on maternity leave. As a further contingency arrangement, for periods of increased IVF cycles or reduced embryology cover, the PR has maintained a satellite arrangement with the Chiltern Hospital (0064). Detailed protocols and checklists have been developed to support this relationship. Payment of treatment fees is timely and the centre is not on the HFEA Finance Department debtors list. Areas for improvement Arrangements exist with other units who provide satellite scans on an irregular basis for infectious cases, these should be formalised and documented appropriately. Currently there is no regular system in place for risk assessment. According to the pre-inspection questionnaire completed by the PR, in the past year only one risk assessment has been carried out. The PR stated that he is planning to develop risk assessment systems as part of the Quality Management System.

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The clinical risk file was found to include one issue which the inspectorate considered should have been reported to the HFEA as an incident. The PR stated that he did not consider that the event could be classed as an incident as it did not involve gametes or embryos. He was therefore reminded by the Inspectorate that adverse incidents are defined in the Code of Practice part 2.24 as “any event, circumstance, activity or action which has caused, or has been identified as potentially causing harm, loss or damage to patients, their embryos and/or gametes, or to staff or a licensed centre” and that these should be reported to the HFEA as required in Code of Practice 2.23. Documented contingency plans for all elements of service should be established. Executive recommendations for Licence Committee Require compliance with Code of Practice part 2.23 Areas not covered on this inspection Resource management Risk management Evaluation Some improvements needed

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2. Quality of service Desired Outcome: Patients receive a good standard of service, appropriate treatment and are treated with courtesy and respect.

Summary of findings from inspection: � Live birth rates � ‘Welfare of the Child’ arrangements � Confidentiality (including safe storage of patients’ records) � Choice of treatments � Privacy and dignity of patients � Complaint handling � Patient feedback and satisfaction � Counselling facilities and services � Donor selection � Egg sharing and surrogacy � Protection of children arrangements (for patients under 18yrs)

Live Birth Rates In the period 01/05/04-01/05/05 HFEA statistics show an overall live birth rate for IVF, ICSI and FET treatments of 22.64%. According to this data, donor insemination live birth rates were 8.57% and live birth rates in egg sharing programmes were 60% and 20% for the donor and recipient respectively. The statistics also indicated that the egg donation (non-egg share) programme had 66.67% live birth rate per cycle. Postnatal data for the following year indicated a 44.83% multiple pregnancy rate with IVF and ICSI treatments but no multiple pregnancies resulting from donor insemination cycles. The HFEA Success Rate Assessment revealed that in the period 31st March 2002-1st April 2005 success rates for IVF and ICSI treatments were not significantly different from the national average. For age bands 38-39 and 35-37 success rates were marginally higher than the national average and for age bands 40-42 and patients below 35 years old the success rates were marginally lower than the national average. The statistics indicated that Frozen Embryo Transfer success rates were above the national average in all age categories. Areas of firm compliance All of the 15 patient questionnaires received by the HFEA were complimentary about the overall quality of service provided by the staff. The HFEA patient questionnaire assessment showed patient satisfaction which was similar to the national average in the following areas; Clinic and staff, Consent and Treatment, Information, and Drugs. All three patients interviewed on the day of inspection expressed satisfaction with the quality of service that they had received. One patient commented that she was so happy with the care provided that although the unit is no longer the most convenient for her she travels in to London to attend appointments. The complaints log was checked during the inspection and it was observed that a sample of complaints had been responded to promptly.

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Areas for improvement During the inspection it appeared that there was a lack of clarity amongst members of staff about the protocol for assessment of “Welfare of the Child”. Two of the three patients interviewed by the inspectorate stated that they did not know how to make a complaint. However, a poster for “suggestions and comments” is present within the waiting room. It was also noted that some members of staff seemed unclear about the procedure to be followed should a complaint be made. All staff should be familiar of this procedure and they should be aware of who the complaints officer is. The HFEA Patient Questionnaire Analysis indicated that patient satisfaction with counselling and sharing information was lower than the national average. Of the 15 questionnaires received 2 patients reported that they were not aware of counselling services and 2 patients stated that the counselling service was not made easily accessible. The Counsellor reported a low uptake of the counselling service; her recent audit of services provided since January revealed that only 8 patients had attended counselling sessions. She felt that this may be a result of the cost of the sessions. It has been proposed by the PR that the counselling sessions may be included in the overall cost of a cycle in future. In response to the findings from the counselling audit and HFEA patient questionnaires it was suggested that the team investigate and monitor the low patient uptake of counselling services. A high percentage of returned questionnaires, 8/15, indicated that the clinic did not explain who is legally allowed to know information about treatment. As a result of this the PR plans to amend the consent to disclosure form so that this information is clear. One patient interviewed stated that, although she was very happy with the overall quality of service she had received, she had experienced problems accessing the centre’s staff via the telephone. The PR does not currently carry out audits on the service provided to patients. However, he plans to introduce a patient questionnaire shortly to aid compliance with the forthcoming EUTD. Executive recommendations for Licence Committee Recommend an audit into the low patient uptake of counselling services. Areas not covered on this inspection Confidentiality (including safe storage of patients’ records) Egg sharing and surrogacy Protection of children arrangements (for patients under 18yrs) Ethics Committee Evaluation Some improvements needed

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3. Premises and Equipment Desired outcome: The premises and equipment are safe, secure and suitable for their purpose.

Summary of findings from inspection:

� Suitable premises � Storage facilities for embryos and gametes � Safe equipment, servicing and maintenance � Prevention of incidents/ accidents

Areas of firm compliance The premises were considered to be fit for purpose by the Inspectorate. Notes are stored behind a reception area which is manned during the day and locked by night. The Laboratory has restricted access to authorised personnel via a key pad system. All dewars are stored within the laboratory and were found to be individually locked. They are now fitted with low nitrogen level alarms and are connected to an auto dial system. The laboratory has separate dewars for the storage of potentially infective material. Evidence of annual maintenance of a sample of key pieces of laboratory equipment was seen in the course of the inspection. As the centre is located within the Chelsea and Westminster Hospital adequate emergency facilities are available should the need arise. An emergency trolley was seen in the treatment room which was considered to be well equipped by the inspectorate. A log for equipment was kept on the trolley; the checks on this were seen to be maintained. Areas for improvement Although low nitrogen alarms have been fitted to the storage dewars, a protocol detailing the response to the alarm has not been developed. In addition the laboratory does not have a protocol delineating the appropriate response to dewar failure. Currently there is insufficient space in the dewars to accommodate all samples should a dewar fail although several dry shippers are available to accommodate some samples in an emergency. The Senior Embryologist advised that the purchase of additional cryopreservation dewars has been agreed. It was suggested that a risk assessment be carried out on the position of the low oxygen alarm. Currently the monitor is positioned behind various pieces of laboratory equipment and as a result the display cannot be seen without entering the laboratory. It is a concern that, as alarms are also fitted to the incubators, members of staff may not be able to tell which alarm had sounded and therefore may respond inappropriately. Although evidence of monitoring of the performance of key pieces of equipment was observed (for example temperature and carbon dioxide levels in incubators, temperature of hot blocks, stages and fridges) these checks had not been completed since May 2006. It was recommended that the checking system be reinstated and that a suitable procedure is developed documenting the actions to be taken if monitoring shows that performance is

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outside acceptable limits. It was also recommended that checks be extended to include monitoring of levels of nitrogen within the dewars to avoid over-reliance on dewar alarms. Executive recommendations for Licence Committee Monitor compliance with CH (04)03 which expects that there should be adequate spare storage space and/or vessels to enable transfer of samples in the event of vessel failure. Areas not covered on this inspection None Evaluation Some improvements needed

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4. Information Desired outcome: Information is relevant, clear and up to date for patients and the HFEA Summary of findings from inspection:

� Information management � Information to patients and donors � Information to the HFEA registry and updates � Consent � Protocols � Record keeping

Outcome of audit of records Nine patient records were examined by the inspectorate. Of these, five had discrepancies, these are listed below:

Error Number of notes (00)6 form not dated 1 (00)6 and (00)7 forms indicate consent for 10 year storage of embryos but no 96/8 form was present

1

(00)7 form had no consent to storage of embryos but section II, wishes after death, was completed

1

(00)7 no partner name was listed 1 Consent to egg retrieval and fertilisation not witnessed and appropriately signed

2

Reasons for 3 ET not documented 2 Renewed Welfare of the Child form following successful treatment

1

Evidence of witnessing at the time of embryo transfer was observed in the patient records. Documentation relating to the witnessing of other key steps undertaken during the treatment was stored in laboratory records. Posthumous consent to birth registration could not be evidenced in records of patients storing sperm or embryos and a member of the embryology team reported that not all patients with embryos or sperm in store have been contacted to advise them of the change in the law. Chair’s letter CH(03)06 advised that clinics should take steps to identify and contact those men who had already consented to storage of sperm or embryos with consent for posthumous use, as they will also be subject to these written consent requirements if they wish to be registered as the father. Areas of firm compliance Patient records are kept in distinctive ACU paper files which reduce risk of confusion with NHS hospital notes. Records are also stored on an electronic database which is password protected. The HFEA Register department are satisfied with the return rate of HFEA forms; the late

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reporting rate is 1% which is within the acceptable range. Areas for improvement Although the patient information was considered to be quite comprehensive and detailed by the Inspectorate, certain pieces of information were not included or need to be amended: • Side effects of stimulation drugs and egg collection procedures were not included. • Information about discomfort, pain and risks associated with egg collections was not

mentioned. Reference to these areas is required in the Code of Practice 5.4iii. • The role and purpose of the disclosure policy is not included in general patient information.

It is planned that the consent to disclosure form will be amended to reflect this. • Information about donor insemination was brief and did not include details about parental

responsibility, sensitivity of tests to be carried out on donors and the possibility that a screened provider of gametes may be a carrier of a genetic disease or infection (Code of Practice 5.6). The information that can now be disclosed to people born as a result of donation also needs to be explained.

• Recent, relevant live birth rates are not included in the patient information. Currently this

information is provided to patients verbally just prior to embryo transfer. The PR has realised the disadvantages of this approach and has planned that in future this information will be presented in a poster format within the waiting room.

• Ovum donor information does not currently include guidance about the importance of

giving a correct and full medical history. The information also needs to be updated so that it is in line with requirements of the SEED review, namely the “ten family events” rather than “10 live birth events” limit for donors.

• Ovum recipient information is not comprehensive on the subject of screening tests for the

donor; this should be revised to include the screening tests required for sexually transmitted diseases and in certain cases sickle cell and thalassaemia.

• The treatment booklet should name the individual responsible for handling complaints and

it should also give their contact details. Of the protocols submitted to the HFEA, clinical and administration protocols had evidence of document version control. However, laboratory protocols had no such evidence and it is recommended that the system for version control is developed and documented for all departments. The Register Department reported a number of errors in the completion of HFEA forms; these were addressed with relevant members of staff who plan to investigate the concerns raised.

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Executive recommendations for Licence Committee Require compliance with Ch (03)06 Require patient information and protocols to be reviewed and version controlled Areas not covered on this inspection None Evaluation Significant improvements needed

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5. Laboratory and Clinical Practice Desired outcome: Staff are competent and recruited in sufficient numbers to ensure safe clinical and laboratory practice.

Summary of findings from inspection:

� Assessment of patients and donors � Safe handling systems � Procedures in practice � Laboratory processes and practice � Clinical practice � PGD/ PGS � Recruitment and retention of staff � Staff competence, qualifications, training and CPD

Full time equivalent staff GMC registered doctors 3 NMC registered nurses 5 HPC registered scientists 1 Scientists working towards registration

2

Support staff (receptionists, record managers, quality and risk managers etc)

3

Summary of laboratory audit An audit of all stored samples was conducted in December 2005. Information about the audit was provided with the pre-inspection questionnaire. However, this did not explain whether any discrepancies were noted and what action had been taken. Greater detail in future audit reports was requested. The Senior Embryologist confirmed verbally that no discrepancies were noted during this audit. Summary of spot check of stored material In the spot check of stored material conducted by the inspectorate one embryo and one set of sperm samples were tracked from dewar to freeze record and vice versa. No discrepancies were detected. Oncology samples were reported to be split and evidence of this was seen in the patient records. Areas of firm compliance Viral positive patients are provided with treatment at the centre. A number of patients are transferred from other Trusts so that they can use this service. A designated laboratory exists which is used to process and store gametes and embryos from infected individuals. A detailed protocol for ovarian hyperstimulation syndrome management was submitted as part of the pre-inspection papers.

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Audits on elements of service are carried out; the Senior Embryologist reported that fertilisation and cleavage rates are audited every two months and that clinical audits on abandoned cycles, OHSS and outcomes have been carried out. Evidence of an audit into “Welfare of the Child” assessments was provided by the PR. Relevant staff are registered with appropriate statutory bodies, evidence of this was produced by the PR. The Inspectorate considered that some improvements in the arrangements for Continual Professional Development have been made since the last inspection. All staff interviewed expressed satisfaction with the provision for their CPD and a number of members of staff reported that they had attended conferences, including the Annual Meeting of the European Society for Human Reproduction and Embryology (ESHRE), this year. The Senior Nurse confirmed that all members of the nursing team have received Basic Life Support (BLS) training in the last three months. The Counsellor has continued with her CPD although this is self-funded. Efforts have also been made to improve the in-house training programme. A training log for the new clinician was made available to the team; which included daily training plans and competency sign offs by a more senior member of the team. Evidence was also seen of supervision and competency checks for a junior member of the embryology team. The system of appraisals has been introduced for the laboratory team and the PR stated that the medical and nursing staff also have formal appraisals on a yearly basis. Monthly education meetings for all staff have been set-up; these involve a presentation by a member of staff about a particular subject followed by discussion of key issues. Examples of these presentations were evidenced during the inspection. Areas for improvement During 2005, 41 three embryo transfers were performed. Of these 5 three embryo transfers were carried out on women aged under 40 years old. Notes from a selection of patients who had received 3 embryos during a transfer were examined by the Inspectorate and it was observed that in some cases the reasons for and discussions regarding 3 embryo transfers (including risks) were not documented in the patient records. In one particular case, a three embryo transfer resulted in a triplet pregnancy. Written protocols on confidentiality, response to failure of storage vessels, cleaning/filling/securing of dewars, management for gametes and embryos in storage and the maintenance and servicing of equipment, have not been developed. Witnessing procedures were described to the inspectorate and evidence of witnessing was observed in laboratory records. However, the protocol for witnessing practice was considered to be brief; information about the responsibility and detailed methodology associated with witnessing was not included. It is therefore recommended that this protocol is reviewed and developed so that it provides clear guidance to trainee and locum members of staff.

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The laboratory is not currently involved in a system of quality assurance. It was suggested that they consider participation in the United Kingdom National External Quality Assessment Service (NEQAS) andrology scheme. Although improvement was noted in staff CPD it is suggested that a documented training programme for staff is developed. Executive recommendations for Licence Committee To note non-compliance with Code of Practice paragraphs 8.20i and 8.19. Areas not covered on this inspection PGD/ PGS Evaluation Significant improvements needed

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Report compiled by: Name……Sarah Hopper……………………………. Designation Inspector ………………………………. Date……………………………………………………………… Appendix A: Centre Staff interviewed Julian Norman-Taylor (PR), Kathryn Mangold (NL) and 7 members of staff

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Appendix B: Licence history for previous 3 years Licensing History

Centre: Assisted Conception Unit, Chelsea and Westminster Hospital

Number: 0158

PR: Mr Julian Norman-Taylor

Licensed for: Storage of Sperm, Storage of Embryos, DI, IVF, IVF with Donor Eggs, Egg Sharing, IVF with Donor Sperm, PZD, ICSI, Intra Cytoplasmic Sperm Injection with Donor Sperm, Chemical Assisted Hatching, Mechanical Assisted Hatching, ZIFT

First licensed 12th October 1996. 2006 Interim Inspection 5th September 2006 2005 Licence Committee 2nd November 2005 – consideration of renewal inspection report The Committee noted that the Executive felt that the centre had made a positive start in addressing the problems discussed at the Licence Committee meeting of the 12th October. The Committee decided to renew the Centre’s licence for a period of 3 years, with no additional conditions. Licence Committee 12th October 2005 – Consideration of Licence Renewal report The Committee noted that the former Person Responsible for the centre, Dr Carole Gilling-Smith, sent a letter of resignation from the post dated 23 September 2005. However, no letter has been received from the centre nominating an alternative Person Responsible. The Committee agreed that the centre must put forward a new Person Responsible as a matter of urgency, as well as making progress on the outstanding issues of concern raised in the inspection report. Members of the Committee also agreed that if this situation were allowed to continue without being addressed, patient safety might begin to be compromised. The Committee decided that the centre should be warned that if the next report to Licence Committee did not indicate that progress is being made then the Committee might have to

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consider suspending the centre’s licence. As no PR was in post the Committee could not make a decision on renewal of the Centre’s licence and so postponed the decision until re-submission of the renewal application form and acceptance of the temporary PR position by Mr. Norman-Taylor. Renewal Inspection 3rd May 2005 2004 Licence Committee 25 October 2004- Consideration of Interim Inspection The Committee decided that the centre should comply with the following requirements: • That the dewar in the infectious diseases laboratory is connected to an autodialler alarm

by the end of June 2005, as specified in Chair’s Letter (04)03 • That the centre ensures that counselling is only carried out by qualified counselors • That the centre implements a formal CPD programme for staff • That the centre submits any outstanding treatment forms, and its OHSS data as soon as

possible • That the centre updates its patient information in response to the changes to the donor

anonymity laws and to include information on parental responsibility with regard to the use of donor gametes

• That the centre presents figures for its frozen embryo transfer rate. Licence Committee 23rd June – change of PR (to re-instate previous PR following maternity leave) Inspection 6th July – interim 2003 Licence Committee 18th December - Initial Research Licence R0150 The Committee agreed to grant a 36 month licence for research project R0150 under the above research purposes to expire 31st December 2006 under the standard licence conditions for stem cell research: Licence Committee 3rd December – change of PR The Committee agreed to recognise Mr Norman-Taylor as Person Responsible Inspection 13th November For a new research licence R0150 Licence Committee 23rd July The Committee recommended that the centre amends the embryo transfer consent form to allow the patient to specify whether they have consented to the replacement of 1, 2, or 3 embryos. Inspection 13th June – interim inspection

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Appendix C: RESPONSE OF PERSON RESPONSIBLE TO THE INSPECTION REPORT Centre Number………… 0158……………………………………………………………………… Name of PR…………… Mr Julian Norman-Taylor………………………………………………. Date of Inspection……… 5th September 2006 …………………………………………….. Date of Response…………25th September 2006………………………………………………… Please state any actions you have taken or are planning to take following the inspection with time scales Breach of Code of practice. A new pro-forma (attached) to be completed by embryology, nursing and medical staff at the time of ET. It ensures that the issues surrounding multiple embryo transfer are fully discussed again. (It is already standard operating practice to discuss these issues at the time of setting up a cycle). The pro-forma also ensures that reasons for 3ET are set out in the notes and recorded in the 3ET log-book. It also points out that 3ET in a women under 40 years of age is a breach of the HFEA Code of Practice, and is not to be considered without full discussion in the MDT and the agreement of the PR (who cannot envisage any reasons why the code might be breached). Contingency plans for the failure of Dewar storage are being developed in conjunction with other local units and will be complete within 3 months of the report of the licence committee. Non-compliance. All staff have been reminded of section 2.24 of the Code of practice in relation to adverse incidents. New written protocols on confidentiality, witnessing, response to damaged storage vessels, cleaning/ filling/ securing of Dewars, management of the gametes and embryos in storage and for the maintenance and servicing of equipment are being developed and will be complete within 6 months of the report of the licence committee. Laboratory are discussing participation of NEQAS When a treatment cycle is planned, patients are given the ‘Treatment Booklet’, which gives information on counselling along with a separate more detailed sheet. In addition there is a notice on the wall advertising the availability of counselling. Accordingly we are planning to conduct an audit of awareness of counselling services, and reasons why there is a low uptake. We are actively considering the appointment of a counsellor for regular on-site appointments. The cost to be included in the cost of treatment. The audit and any new procedures will be completed within 6 months of the report of the licence committee.

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A protocol for response to Dewar failure and low oxygen will be developed within 3 months of the report of the licence committee. Oocyte donor and recipient information has been update in line with the inspectors’ recommendations and is attached. Donor sperm information will take the form of the HFEA leaflet forthwith. CPD is currently an important part of our unit, with intensive, organised training of the junior medical staff and monthly educational meetings specifically aimed at all the staff. All staff have attended external meetings, such as ESHRE or Insights. All staff keep a full record of their CPD – evidence of this was not asked for on the day of inspection. We plan to make the evidence of our training program for all staff clearer and more structured A senior embryologist will carry out a risk assessment of the current alarm system for responding to dewar failure within 3 months of the report of the licence committee. In relation to other points in the report. 1. Organisation. We have satellite arrangements with several clinics on an ad hoc basis for infectious cases. A formal agreement pro-forma is to be developed as part of the requirements for EUTD. Our Risk Assessment system will become more formalised as part of the requirements for EUTD. In relation to the unreported clinical incident: The incident has now been reported as requested by the HFEA inspectors. However I have discussed this issue with 3 other PRs and 2 former HFEA inspectors. The incident itself was minor everyday occurrence and it is correct that we should have gone through the in-house risk assessment that we did. None of my colleagues felt that an incident of this nature would normally be required to be reported to the HFEA. It is also a central tenant of ‘Risk Management’ that there should be no actual or inferred criticism associated with the practice. The HFEA should strongly consider separating the process of inspection from the process of incident reporting. Documented contingency plans for failure of all elements of the service will be established as part of the requirements for EUTD. 2. Quality of Service. The WoC process is clearly documented in the protocols. A staff meeting has been held to reminded us all as to the process and its importance. The process of making a complaint is clearly documented in the patient treatment booklet and on a poster on the wall. The team will discuss how this can be highlighted to patients. The wall poster contains a named person as the complaints manager. We will include this in other documentation.

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The availability of counselling is clearly documented in the patient treatment booklet and on a poster on the wall. The team plan to audit why there is a low uptake with a view to improving awareness and possibly developing extended counselling services. We plan to use the new HFEA Consent to Disclosure, and a protocol is developed to ensure its completion. We are aware of the failure of the telephone system to provide a satisfactory service. We are in discussions with ThamesNet, our telephone service provider, as to how this might be improved. We plan to introduce patient audits as part of the requirements for EUTD 3. Premises and Equipment A protocol for response to Dewar failure and low oxygen will be developed within 3 months of the report of the licence committee. We are in the process of purchasing additional Dewar storage. A risk assessment will be carried out in relation to the low oxygen alarm and the alarms fitted to the incubators. The processes and protocols for the maintenance of laboratory and other equipment are being developed as part of the requirements for EUTD. 4. Information The process of distribution of the Posthumous Consent to Birth Registration forms is to be reviewed. It is protocol to review, with the patients, all the risk of treatment, including ohss and other side-effects of medication during consultation. There is a list in the Patient Treatment Booklet which the doctor goes through with the patient. A revised version of The Patient Treatment Booklet is to contain more information in relation to the side effects of the medications. It is protocol to review, with the patients, all the risk of treatment, including complications of egg collection. There is a list in the Patient Treatment Booklet which the doctor goes through with the patient. A revised version of The Patient Treatment Booklet will further emphasise the risks and complications of the egg collection procedure. We plan to use the new HFEA Consent to Disclosure, and a protocol is developed to ensure its completion. Donor sperm information will take the form of the HFEA leaflet forthwith. Recent and relevant live birth rates are to be displayed in the waiting/reception area. Oocyte donor and recipient information has been update in line with the inspectors’ recommendations and are attached.

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A revised version of The Patient Treatment Booklet will contain the name of the complaints officer. Version control is to be introduced for all documents as part of the requirements for EUTD. 5. Laboratory and Clinical Practice. A clinical attachment from abroad performed a 3ET which resulted in a triplet pregnancy. She was from a country where multiple ET is common practice. It is now the policy of the unit that no one is permitted to perform unsupervised ET in the unit without having completed appropriate accreditation and received specific guidance on the regulations surrounding multiple ET in the UK. In addition a new pro-forma (attached) is to be completed by embryology, nursing and medical staff at the time of ET. It ensures that the issues surrounding multiple embryo transfer are fully discussed again. The pro-forma also ensures that reasons for 3ET are set out in the notes and recorded in the 3ET log-book. It also points out that 3ET in a women under 40 years of age is a breach of the HFEA Code of Practice, and is not to be considered without full discussion in the MDT and the agreement of the PR. New written protocols on confidentiality, witnessing, response to damaged storage vessels, cleaning/ filling/ securing of Dewars, management of the gametes and embryos in storage and for the maintenance and servicing of equipment are being developed and will be complete within 6 months of the report of the licence committee. The laboratory team is discussing participation of NEQAS A more fully documented staff training program is being developed as part of the requirements for EUTD I have read the inspection report and agree to meet the requirements of the report. Signed…………………………………………………………………………………………………… Name……………………………………………………………………………………………………. Date………………………………………………………………………………………………………

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2. Correction of factual inaccuracies Please let us know of any factual corrections that you believe need to be made (NB we will make any alterations to the report where there are factual inaccuracies. Any other comments about the inspection report will be appended to the report). Page 1. The Nominal Licensee is Kathryn Mangold (report amended in response- SH) Page 9. Mention is made of ‘high levels of staff absenteeism and staff turnover’. This is not a fair reflection. There have been locum embryologists in the lab, but this was largely due to cover for maternity leave, which is a very different thing. (Comment considered and report amended in response -SH). Page 19. In relation to the patient who conceived with a triplet pregnancy, the unit has not received a verbal, written, formal or informal complaint from this patient. (Comment considered and report amended in response -SH) We also welcome comments about the inspection on the inspection feedback form, a copy of which should have been handed out at the inspection. If you require a copy of the feedback form, please let us know. Please return Appendix C of the report to: Regulation Department Human Fertilisation & Embryology Authority 21 Bloomsbury Street London WC1B 3HF