Licence Renewal Inspection Report for Treatment and Storage Centres Brentwood Fertility Centre 0165 Date of Inspection: June 29 th 2006 Date of Licence Committee: October 11 th 2006 Page 1 of 22
CENTRE DETAILS Centre Address Brentwood Fertility Centre Essex Nuffield Hospital Shenfield Road Brentwood Essex CM15 8EH Telephone Number (01277) 695680 Type of Inspection Person Responsible Nominal Licensee Licence Number Inspector(s) Fee Paid - date Renewal ( short notice) Mr Rahim Haloob Mr Satha Sathanandan L0165-9-a Janet Kirkland (Lead inspector HFEA) Dr Victoria Lamb (Scientific inspector HFEA) Dr Marion Witton (Head of inspection HFEA) Mr Peter Brinsden (External advisor clinical) Not due Licence expiry date 31 st December 2006 Page 2 of 22
Index Page Centre details... 2 Index... 3 About the Inspection... 4 Brief Description, Activities Summary & Risk Assessment... 5 Evaluation & Judgement... 7 Breaches, Non-compliance Records, Proposed Licence... 8 Changes/Improvements, Additional Licence Committees... 9 Organisation... 10 Quality of Service... 12 Premises and Equipment... 14 Information... 16 Laboratory and Clinical Practice... 17 Appendix A... 19 Appendix B... 21 Appendix C... 22 Page 3 of 22
About the Inspection: This inspection visit was carried out at short notice on 29 th June 2006 and lasted for six hours. The report covers the pre-inspection analysis, the visit and information received between July 2006 and June 2007. 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 licence renewal 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. Page 4 of 22
Brief Description of the Centre and Person Responsible The centre has been licensed since 1998 and offers treatment to private patients who are either referred through their GP or through the two consultants at the centre who also hold fertility clinics at the local Basildon and Harold Wood Hospitals. The centre is licensed to carry out donor insemination (DI), in vitro fertilization (IVF), IVF with donor gametes, intracytoplasmic sperm injection (ICSI), assisted hatching (mechanical and chemical), storage of sperm, storage of embryos, storage of sperm within testicular tissue, zygote intra-fallopian transfer (ZIFT) and gamete intrafallopian transfer (GIFT). Approximately 290 licensed treatments have been performed in the previous twelve months. The centre is situated within the Nuffield Hospital and patients attending for surgical procedures attend the general theatre suite of the Hospital. A service is provided of initial screening and work up for patients for a donor egg programme in Spain. Three patients are reported as having used this service in the previous twelve months. Major refurbishments are planned for the centre. Since its inception the centre has been granted licences for one year only because of previous concerns. The last twelve months have seen a significant improvement in compliance with regulations and communications between the Person Responsible and the HFEA. The Person Responsible, Mr Haloob has been at the centre since 1998 and was appointed Person Responsible in January 2003. He is on the General Medical Council (GMC) specialist register and has completed training recognised by the Royal College of Obstetricians and Gynaecologists (RCOG). A previous Licence Committee recommended that the attention of the Person Responsible should be drawn to his responsibilities, particularly in relation to the requirements to ensure that information about the HFEA requirements are disseminated effectively amongst centre staff. There is sufficient evidence that this has been achieved. Page 5 of 22
Activities of the Centre Licensed treatment cycles IVF 158 ICSI 92 FER 13 Donor Insemination 10 Unlicensed treatments Research Storage Artificial insemination Monitored cycles None Yes Summary for Licence Committee Brentwood Fertility Centre has been licensed since 1998. Throughout this period it has been issued with licences for a period of twelve months only. The centre will in the following months undergo major refurbishment to the laboratory area. The team have actively sought advice from the HFEA during the previous few months and lines of communication have been established. A new nurse manager has recently been appointed. She had previously been a member of the team in 1998 when the centre was in the planning stages. She now offers experience, commitment and enthusiasm to the centre team. The laboratory manager / Senior Scientist provided the inspection team with laboratory protocols within the time limit required by previous Licence Committee. The inspection team noted improvements in the protocols and compliance with regulations and recommendations since the last inspection and recommend renewal of the licence for a period of three years. The Person Responsible has committed to keeping the Executive informed regarding the refurbishment of the premises and contingency plans for treatments over the following months. He has provided extensive contact details for himself and other team members and has invited the Executive to re-visit the centre at any time. Inspection teams have visited three times in the previous twelve months and will revisit on completion of the refurbishment. Page 6 of 22
Risk Assessment The current risk assessment for the centre based on the risk matrix is 37% Overall judgement of the effectiveness of the centre No Improvements required Some Improvement required Significant Improvement required Evaluations from the inspection Topic No Improvements required Some Improvement required 1. Organisation 2. Quality of the service 3. Premises and Equipment 4. Information 5. Laboratory and clinical processes Significant Improvement required Page 7 of 22
Breaches of the Act or Code of Practice Breach Action required Time scale One patient s sperm samples in long term storage have not been split in accordance with Chair s letter. Non-Compliance Laboratory team to investigate, risk assess and inform executive of actions taken. Immediate. The Senior Scientist has since the inspection informed the executive that this sample was transferred to the centre in 2004. The sample was not screened when it was frozen. At present there is only one tank for unscreened semen samples and therefore the sample cannot be split. Another tank will be purchased when the alterations to the premises have been completed. Area for improvement Action required Time scale None Recommendations Time scale The Person Responsible to keep the on going Executive informed of commencement of refurbishment, and contingency plans for treatment cycles during this period. The Executive to inspect centre on completion. All protocols to be version controlled April 2007 Proposed licence variations The centre will be inspected on the completion of the refurbishment. Page 8 of 22
Changes/ improvements since last inspection Recommendation The attention of the Person Responsible be drawn to his responsibilities particularly in relation to the requirements to ensure that information about the HFEA requirements are disseminated amongst centre staff. Clinical audit to be submitted by March 2006. Executive to monitor extension of premises. The counselling external advisor suggested that a counselling leaflet be produced. Action taken Minutes of monthly meetings submitted to the HFEA provide evidence that the Person Responsible has attended the majority of the meetings and document feedback and contact with the HFEA. Staff interviewed stated that the Person Responsible ensured that all staff were aware of communications from the HFEA. Clinical audit of oocyte donation cycles submitted within the required timescale. Extensive refurbishment planned. The Executive updated accordingly A counselling leaflet has been produced and is included in the patient information pack and is also available in the waiting room Additional licence conditions and actions taken by centre since last inspection C Laboratory protocols and standard operating procedures have to be submitted by 1 st March 2006 A Yes Page 9 of 22
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 Person Responsible and staff have since the previous inspection improved communications with the HFEA seeking guidance and updating the Executive of plans for the refurbishment. The inspection team assessed that the centre was well organised, and whilst the two consultants have commitments elsewhere, the nursing team report that they can seek guidance from them at any time. A new nurse manager has recently been appointed. She had previously been part of the team when the centre was in the planning stages and she demonstrated a good understanding of the centre s activities and of regulatory issues. All staff interviewed were aware of the incident reporting system. The centre incident folder was reviewed by the inspection team. The Person Responsible has, since the previous inspection, reported an incident regarding the low level oxygen alarm. The team hold multidisciplinary meetings and minutes of meetings have been sent to the HFEA on a regular basis. The minutes evidence communications with the HFEA. Major refurbishments are planned for the centre and the Person Responsible is maintaining a dialogue with the Executive regarding the proposed time scale and contingency plans for patients attending the centre during this period. Page 10 of 22
Areas for improvement The Person Responsible previously reported difficulties in identifying a satisfactory mode of communication with the HFEA. Since the inspection he has provided the lead inspector with an extensive list of phone numbers for himself and key team members. On the day of the inspection the lead inspector also discussed the systems in place for contacting the HFEA. It was noted in the self assessment document that the team do not have a written agreement/contingency plan in the event that treatments are unable to be completed or carried out at Brentwood. Executive recommendations for Licence Committee None Areas not covered on this inspection None Evaluation Some improvement required Page 11 of 22
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 The treatment results are audited monthly and information which is sent to patients updated annually. Areas of firm compliance Staff interviewed confirmed that they were involved in Welfare of the Child discussions and aware of the process of assessments. Patient records were seen to be stored in locked cabinets in a room which is locked when not in use. Patients are given information both verbally and in writing. Patient information reviewed by the inspection team was considered to be satisfactory. Patients are allocated a private room within the general pre - and post operative ward when they attend for oocyte collection. These rooms were seen by the inspection team and found to be both private and comfortable. The complaints folder was reviewed by the inspection team. Staff interviewed were aware of the complaints procedure and leaflets were seen to be in the patient s waiting area. This inspection was performed with short notice and therefore HFEA patient questionnaires were not issued prior to the inspection. Patients are issued with centre questionnaires post embryo transfer. These were seen by the inspection team and cover areas such as: contact with the clinic, continuity of care and information provided. Responses are reviewed and actions taken accordingly. Patients interviewed on the day of the inspection expressed satisfaction with their treatment and care. Page 12 of 22
An audit of counselling services was provided for the inspection. A total of 87 sessions took place compared to 97 in the previous twelve months. The audit indicated that 14 patients had been seen with regards to egg donation or egg recipient and one regarding surrogacy. It was reported in the audit that all patients are given the counsellors details to contact directly or via centre staff. They are encouraged by the counsellor to make contact at any time during and after treatment. Areas for improvement The centre s live birth rate is below the national average for all treatments offered. The Person Responsible suggested that many of his patients have, taking into account their history, a low chance of success and they are counselled accordingly. The Person Responsible is committed to improving the success rates with continual audit and review of protocols and treatments offered. It was noted by the inspection team that telephone conversations in the office could at times be clearly heard in the waiting room. Executive recommendations for Licence Committee None Areas not covered on this inspection The counsellor was unable to attend on the day of the inspection. An audit was provided for the inspection team which was informative and included comments and recommendations. Evaluation Some improvement required Page 13 of 22
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 inspection team followed the pathway the patients take on the day of oocyte collection. The patients and partners attend the general surgery unit of the hospital. They are cared for by the theatre and ward team of the Nuffield hospital. The nurse manager explained that members of the centre team ensure that they visit the patients while they are in this area and provide information and instruction. This arrangement will remain unchanged after the refurbishment of the centre. Access to the storage area was seen to be restricted by a keypad lock. All dewars were seen to be locked and alarmed and a low level oxygen alarm was in place. Records checked by the inspection team included: nitrogen top up, temperature checks and daily work sheets Areas for improvement Major refurbishment is planned for the centre. The area affected will primarily be the laboratory. The close proximity of the laboratory to the patient areas such as consulting rooms, waiting area and scan room will have an impact on the centre as a whole. It was discussed with the Person Responsible and it is his intention they suspend all clinical and laboratory procedures throughout the time of the refurbishment. The Person Responsible will provide the executive with the final plans for the centre along with contingency plans regarding treatment cycles and a time scale for the work to be carried out as soon as they have been finalised. Executive recommendations for Licence Committee The Person Responsible to provide the Executive with final plans for the refurbishment as well as a contingency plan for patient care during this time. Since the inspection the Person Responsible has provided minutes of staff meetings. These minutes document the continuing discussions regarding the dates for the commencement of building work and the scheduling of treatment cycles. Page 14 of 22
Areas not covered on this inspection None Evaluation Significant improvement required and planned Page 15 of 22
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 Seven patient records were reviewed at the inspection. These were found to be in good order with evidence of Welfare of the Child assessment, consent to disclosure and HFEA consents to use and storage. Areas of firm compliance Patients are given information both verbally and in writing. Patient information reviewed on the day of the inspection was found to be clear and informative. Registry at HFEA reported no issues of late reporting. Areas for improvement Not all protocols were version controlled. Some patient files reviewed at the inspection were found to have missing consents these were discussed at the feedback session. Executive recommendations for Licence Committee None Areas not covered on this inspection None Evaluation Some improvement required Page 16 of 22
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 2 NMC registered nurses 2 HPC registered scientists Support staff (receptionists, record managers, quality and risk managers etc) Summary of laboratory audit Awaiting results from centre 2 + 1 trainee 1 Summary of spot check of stored material Two samples of sperm and two of embryos were tracked from records to dewar and dewar to records. There were no discrepancies in location. It was discovered that one patient s samples in long term storage had not been split in accordance with Chair s letter. It was also noted that embryos were stored beyond the statutory period and the patient s consent to extended storage could not be located. The laboratory manager has since the inspection provided the inspection team with a copy of the patients consent to extended storage which evidence that it had been completed prior to the inspection. Areas of firm compliance A new nurse manager has been appointed who had previously been part of the team to set up the centre at Brentwood. She appears to be both enthusiastic and committed and will be of great value through the refurbishment of the centre and the establishing and updating of protocols. Areas for improvement It was noted that whilst centre staff indicated that they were satisfied with levels of continuing education this had at times been self funded or funds had been sought from commercial companies. Page 17 of 22
Executive recommendations for Licence Committee The laboratory manager to investigate the reason why a sample in long term storage has not been split and advise the Authority accordingly. Areas not covered on this inspection PGD/PGS Evaluation Some improvement required Page 18 of 22
Report compiled by: Name Janet Kirkland. Designation HFEA Lead inspector. Date 19 th July 2006 Appendix A: Centre Staff interviewed Person responsible: Mr Rahim Haloob Nominal Licensee: Mr Sath Sathananthan Senior Scientist: Shantal Rajah / Laboratory manager and Senior Scientist Three other centre staff Page 19 of 22
Appendix B: Licence history for previous 3 years First Licensed 1998 2006 Inspection 29 th June 2006 2005 Licence Committee November 2005 The Committee agreed to renew the licence for one year with one condition Inspection 20 th July 2005 2004 Licence Committee 25 th October 2004 The Committee agreed to renew the licence for one year with one condition and seven recommendations. Inspection 18 th August 2004 2003 Licence Committee 3 rd December 2003 The committee agreed to renew the licence for one year with one additional condition and six recommendations Inspection 20 th November 2003 (Clinical follow up) Inspection 11 th September 2003 Licence Committee 29 th January 2003 The Committee agreed to the variation of the licence to recognise Dr Haloob as Person Responsible. Page 20 of 22
Appendix C: RESPONSE OF PERSON RESPONSIBLE TO THE INSPECTION REPORT Centre Number - 0165 Name of PR - A. Rahim Haloob Date of Inspection 29 th June 2006 Date of Response 2 nd August 2006 Please state any actions you have taken or are planning to take following the inspection with time scales Most of the points raised by the inspection team will be met by the time the expansion plan is completed. I have read the inspection report and agree to meet the requirements of the report. Name. Date 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 21 of 22
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 Page 22 of 22
Licence Committee Meeting 11 October 2006 21 Bloomsbury Street London WC1B 3HF MINUTES Item 3 Brentwood Fertility Centre (0165) Licence Renewal Members: Emily Jackson, Lay Member Chair Richard Harries, Lay Member Ivor Brecker, Lay Member Maybeth Jamieson, Consultant Embryologist, Glasgow Royal Infirmary In Attendance: Frances Clift, Legal Adviser Marion Witton, Head of Inspection Claudia Lally, Committee Secretary Conflicts of Interest: members of the Committee declared that they had no conflicts of interest in relation to this item. The following papers were considered by the Committee: papers for Licence Committee (37 pages) no papers were tabled. 1. The papers for this item were presented by Janet Kirkland, HFEA Inspector. Ms Kirkland informed the Committee that the centre has been licensed since 1998. The centre has a mixed history of regulatory compliance, however the inspection team gained a favourable impression of the centre and noted the improvements in the protocols and compliance with regulations and recommendations. 2. Ms Kirkland informed the Committee that the centre has planned a refurbishment of the premises and has committed to keeping the Executive informed about this. 3. The Committee noted the centre s low success rates and asked Ms Kirkland to comment. Ms Kirkland replied that the centre explains these rates in terms of the group of patients which they treat. However, the centre is committed to continually auditing their results and working towards their improvement. 4. The Committee asked Ms Kirkland to explain the fact that the centre has a relatively high risk score despite the fact that the inspection report had been
largely favourable. Ms Kirkland replied that the high risk score is a reflection of historical concerns about the centre rather than the most recent inspection. This was noted by the Committee. 5. On the basis of the relatively high risk score the Committee decided to renew the centre s licence for a period of three years. Signed. Date.. Emily Jackson (Chair)