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Date of Inspection: 19 November 2009 Length of inspection: 5 hours Inspectors: Dr Chris O’Toole Dr Maybeth Jamieson Ms Mim Glenn Inspection details: The report covers the pre-inspection analysis, the visit and information received with the new licence application and subsequently. Date of Licence Committee: 14 December 2009 Purpose of the Inspection report The purpose of the new licence inspection is to assess whether centres will comply with the HF&E Act 1990 (as amended), the HF&E Act 2008 and the Code of Practice and to ensure that new centres will provide a quality service for patients. The report summarises the findings of the new licence inspection highlighting areas of good practice, as well as areas where further improvement is required to improve the future patient services and meet regulatory requirements. It is primarily written for the Authority’s Licence Committee which will make the decision about the centre’s licence application. Centre details Centre Name Leeds Centre for Reproductive Medicine Centre Number Centre Address

Seacroft Hospital York Road Leeds LS14 6UH

Telephone Number Proposed Person Responsible

Mrs Vinay Sharma

Proposed Licence Holder

Professor Peter Bellfield

Date of proposed licence issue

December 2009 – Storage Licence January 2010 – Treatment Licence

Additional conditions to be applied to this licence

None

New Centre Licence Inspection Report

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Contents Page Centre details………………………………………………………………………………………1 Contents…………………………………………………………………………………………….2 Report to Licence Committee/Executive Licensing Panel…………………………………3

Brief description of the centre and its licensing history Proposed activities of the Centre Updated actions since the centre was inspected Summary for licensing decision Recommendation to the Licence Committee

Detail of inspection findings…………………………………………………………………….7

Risk to patients and children born as a result of treatment services Patient Experience Protection of embryos Good governance and record keeping Changes / improvements since the last inspection

Areas of proposed practice that require the attention of the Person Responsible…..20

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Report to Licence Committee Brief description of the centre and its licensing history: The Leeds Centre for Reproductive Medicine is based within the Leeds Teaching Hospitals NHS Trust. At present there are two reproductive units; one based in the Clarendon Wing at Leeds General Infirmary (Centre 0052) and the other is located in the Gledhow Wing of St James’s University Hospital (Centre 0063). Both these units have been licensed by the HFEA since 1991. The two units plan to merge in a newly deveoped facility at the Seacroft Hospital in January 2010. The new facilities are a purpose-built refurbishment of two ward areas within the Seacroft Hospital. The site is a few miles from the city centre and is well served by public transport, being on the major trunk road between Leeds and York; in addition, the site offers much improved parking. The service aims to perform approximately 2000 cycles of IVF/ICSI per annum, along with associated frozen embryo transfers and IUIs. It will operate seven days each week, though egg collections will not be performed on Sundays. Reconfiguration will allow a consultant-led service combining not only tertiary level assisted conception treatments but secondary level clinics. Sedation will also be provided by consultant anaesthetists. The facility covers almost 1500 square metres. This includes four key laboratories for embryology, cryopreservation, sperm preparation for treatment and semen analysis/routine andrology. Laboratory areas are designed to attain clean room standards with an air handling plant that can provide class B air. There is also an administrative area for embryologists just off the main laboratory, as well as a dedicated research laboratory and cryostorage area. There will be a large patient waiting area, and adjoining suite of dedicated consulting and ultrasound rooms, together with procedure rooms and two-stage recovery areas. In addition, the facility will provide a discreet suite of rooms for sample production away from thoroughfares. Proposed activities of the Centre: At the new premises, the centre will provide to self-funded and NHS patients, the full range of licensed treatment that centres 0052 and 0063 currently provide, i.e: IVF/ICSI; frozen embryo transfers; donor insemination; intrauterine insemination; sperm, oocyte and embryo storage; oocyte sharing; oocyte and sperm donation. The proposed Person Responsible had applied to for preimplantation genetic diagnosis and preimplantation genetic screening to be included on the centre’s licence. However, following discussions with the person responsible and senior embryologists, during the inspection visit, the proposed Person responsible stated that she would like to withdraw this application and that they would apply at a future date for these two activities to be added.

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Updated actions since the centre was inspected on 18 November 2009 None

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Summary for licensing decision: In considering overall compliance, the Inspector considers that they have sufficient information drawn from documentation submitted by the centre prior to inspection and from observations and interviews conducted during the inspection visit to conclude that:

• the proposed PR is suitable and whether she will discharge their duty under section 17 of the HF&E Act 1990 (as amended).

The proposed PR is accredited with the General Medical Council (GMC) as both Consultant Obstetrician & Gynaecologist and a sub-specialist in reproductive medicine. There are no restrictions on her registration. The proposed PR has been the HFEA Person Responsible and head of service at the assisted conception unit (Centre 0063), at St James’s University Hospital, Leeds since 1991. The proposed PR has completed the PR entry programme (PREP) to the satisfaction of the executive. The report of the renewal inspection of centre 0063carried out in 2008 highlighted no areas of concern in relation to the proposed PR’s ability to carry out her statutory duties.

• the proposed premises are suitable

The premises were inspected before being handed over by the contractors and were therefore unequipped. The premises seemed appropriate for the centre’s activities and should provide a safe, clean and private environment for patients and centre staff. The premises are currently suitable to allow the storage of gametes and embryos because the cryostorage laboratory has been fitted with low level oxygen alarms and all the cryostorage dewars are fitted with low level nitrogen alarms. As the rest of the centre was unequipped, the inspection team can not state whether the premises who be suitable to carry out licensed treatment services.

• the proposed practices are suitable. The centre has standard operating procedures are all the proposed licensed activities. All staff are experienced and competent to carry out their designated jobs.

• the centre has submitted appropriately completed documentation in application

for the new licence. • the centre has submitted an application fee to the HFEA in accordance with

requirements.

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Recommendation to the Licence Committee / Executive Licensing Panel: The inspector considers that, overall there is sufficient information available to recommend the issuing of a storage licence to the new centre for a period of one year on the condition that the Person Responsible confirms that the testing of the filling systems and alarms, using the two empty dewars, has been successfully completed. The inspector recommends that a further inspection takes place in early January 2010 to check that all equipment has been installed and validated. It is recommended that a report of that inspection be presented to the Licence Committee prior to a treatment licence being granted.

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Details of Inspection findings 1. The premises to be used to provide treatment activities under the proposed new licence The Leeds Centre for Reproductive Medicine is a new purpose built unit comprising of: 5 consultants’ offices 1 secretaries office 2 office / note rooms Dispensary Meeting room Reception waiting area 3 admin offices Drs / nurses office Staff rest room 2 consultation rooms 5 consultation / scan rooms 3 scan rooms 3 counselling rooms 4 patient toilets - 1 with disabled access 5 sperm production rooms – 1 with disabled access and a shower 2 patient changing rooms – 1 with disabled access 8 bed recovery area + day case waiting area and recovery stage 2 2 staff changing rooms – 1 male and 1 female both with shower and toilet Sperm reception room Seminology / sperm analysis room Seminology / treatment room Embryology laboratory – 3 ISCI stages Crypreservation area Cryo store Notes room Research laboratory Store rooms Cleaning stores If this application is approved, the Centre will relocate during December 2009 and January 2010, according to the relocation plan submitted to the HFEA, ensuring impact on patient care at both the Clarendon Wing and St James’ Hospital is minimised. The proposed PR would like the new centre to be licensed to store cryopreserved gametes and embryos from 16 December 2009 and for other licensed activities to commence at the new premises on or before 25 January 2010, assuming all regulatory requirements have been satisfied and the staff consider the premises suitable to their needs. The premises were inspected before being handed over by the contractors and were

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therefore unequipped. The premises seemed appropriate for the centre’s activities and should provide a safe, clean and private environment for patients and centre staff. Security The main entrance and all internal rooms are protected by a swipe-card security system. There are three levels of access: level 2 authorisation is required for clinical areas and the laboratories require level 3 permission. Laboratories A semen reception area is situated beside the male production rooms. Samples for analysis are received and booked in by a laboratory witness who will also show patients into the rooms. Samples for treatment or freezing will be received by an embryologist who will carry out the necessary identity checks and witnessing. Diagnostic semen analysis will be carried out by in the hospitals pathology department which is accredited by the Clinical Pathology Accreditation Ltd. Male and female staff changing areas are situated outside the laboratory suite and the laboratory area is entered via a ‘step-over’ area where staff will change into dedicated clean area footwear. The main laboratory has been built to a high specification and is well equipped with power sockets and IT connections. The design excludes any horizontal surfaces and all equipment will be mounted on metal stands to facilitate cleaning. The light fittings and windows screen UV light. Hatches connect the laboratory to each of the three procedure rooms. The hatches are electronically linked to the ‘engaged’ signs outside the clinical rooms to ensure that air quality is not compromised during procedures. In order to minimise movement within the laboratory, it is intended to create a work area in conjunction with each of the procedure rooms. These will comprise an IVF workstation, incubators and an ICSI rig. There is sufficient space to add further equipment if required. Laboratory gasses are piped from a dedicated store situated outside the clean area and equipped with appropriate ventilation, alarms and change-over units. The store is designed to allow the use of two different gas mixtures if required. A research laboratory finished to the same specification opens off the main area and a separate area for embryology record keeping is designed to minimise the used of paper in the critical work area. The cryo-storage room is adjacent to the main laboratory and is fitted with three low oxygen sensors linked to visual and audible alarms. The room has constant ventilation fitted at the appropriate height for nitrogen use; the system can be accelerated in the event of a spillage. Liquid nitrogen is supplied via insulated pipes from an external 900L tank. The room will house freezing machines and 38 dewars. The Consultant Embryologist recognises that this is close to the maximum capacity of the area and that alternative, high capacity, storage

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containers may be needed in the future. Dewars will be fitted with temperature and low level alarms. The system can be interrogated remotely via a secure internet link and will also monitor incubator CO2 levels and temperatures. This system is new to both Units and a revised protocol for responding to alarms has been developed. All laboratory equipment is linked to a back-up power system. This comprises a stand alone uninterruptible power supply (UPS) and the main hospital emergency generator. The UPS system is capable of supplying power for four hours in the event of the failure of both supplies. A stand alone air handling system has been designed to provide HEPA filtered air to the theatre and laboratory areas. The system is capable of providing Grade B air but the intention is to operate at Grade C for normal use. The designers will commission and validate the system before the building is handed over. Following a programme of deep cleaning, the system will be re-checked and responsibility for testing air quality will be taken over by QA Pharmacy who performs this function for all clean rooms within the Trust. As in the existing laboratories on both sites, monitoring includes particle counts and microbiological testing. Equipment Proposed equipment was discussed with the Centre management team and their plans suggest the premises will be appropriately equipped. All equipment will be transferred from the two currently licensed premises. Appropriate arrangements have been developed for cleaning, maintaining and securing the premises and the equipment within it. Transfer of Stored Samples and Equipment A detailed plan has been developed for the transfer of stored gametes and embryos, equipment, furniture and other material from the existing sites. This includes risk assessments for all aspects of the movement of critical material and equipment. Prior to the transfer, equipment will be decommissioned at the existing sites and decontamination certificates supplied. Separate teams of clinic staff will be responsible for dispatching and receiving material on the three sites. ‘Benchmark’, a specialist laboratory removal company will pack and move dewars containing cryopreserved material and laboratory equipment. These transfers are currently scheduled for 21st December (Centre 0052) and 4th January (Centre 0063). ‘Pickfords’ will move fragile items such as computers and medical equipment and ‘City Transfers’ will transfer furniture. Patient Information Patients with cryopreserved gametes or embryos have been informed of the move and have been given contact details for the new Unit.

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Commissioning New Premises Two empty dewars will be moved to Leeds Centre for Reproductive Medicine prior to the transfer of patients’ material and will be used to test the filling systems and alarms. Engineers have been booked to fit and commission the new dewar and incubator monitors and alarms before material is moved from the existing sites. Engineers have been booked to re-commission service and calibrate all critical medical and laboratory equipment. Appropriate certification will be obtained. Laboratory staff will validate all equipment using existing standard operating procedures and documentation prior to the resumption of patient treatment. Process validation will be carried out for any new or amended procedures. Amalgamation of Staff and Procedures In advance of the merger, standard operating procedures have been standardised as much as possible. Senior staff have been meeting regularly to agree the new protocols. Senior embryologists have worked in both Units. All staff will undergo a re-induction programme covering any changes to processes and equipment. A period of two weeks is available for staff training and equipment and process validation prior to scheduled treatment. Cryostorage records Cryostorage records at Centres 0052 and 0063 were kept in different formats. The systems have been amalgamated and a complete computer record will be available when the samples are transferred. In addition, a hard copy of the data has been produced and an individual record placed in patients’ notes.

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2. The qualifications and experiences of the key staff who will provide treatment activities under the proposed new licence The proposed PR is accredited with the General Medical Council (GMC) as both Consultant Obstetrician & Gynaecologist and a sub-specialist in reproductive medicine. There are no restrictions on her registration. She is also a designated consultant for the Centre. The proposed PR has been the HFEA Person Responsible and head of service at the assisted conception unit (Centre 0063), at St James’s University Hospital, Leeds since 1991. Mrs Sharma completed the PREP in 2006. The report of the renewal inspection of centre 0063 carried out in 2008 highlighted no areas of concern in relation to Mrs Sharma’s ability to carry out her statutory duties. The centre had provided a complete staff list prior to the visit. However, during the discussion with the proposed Person Responsible (PR) the original list submitted needs to be amended. The PR stated that she would send an up dated list. In summary There are three accredited consultants; a further consultant will be recruited in early 2010. These are supported by 9 doctors and a team of consultant anaesthetists. There are 12 full time registered nurses and 15 part time nursing staff, whose hours range from 14 to 34 hours per week. The head of the embryology and andrology laboratories is a consultant embryologists and is registered with the Health Professional Council (HPC). He is supported by 8 clinical embryologists (5 are registered with the HPC and 3 are working towards registration) and 3 trainee embryologists. In addition there are two reproductive technologists and three dedicated witnesses. The senior counsellor confirmed that the team of six part time counsellors are able to provide, all patients, free counselling sessions on one to one bases, before, during and after any treatment, and for as long as they require it, For those patient based in North Yorkshire and find it difficult to attend the Leeds centre, a counsellor is based in the region which enable these patient, to receive the same level of service. Referrals are received either by the medical, nursing staff or the patient self referral themselves. Information leaflets are sent out to patients at first contact. All staff are considered to be appropriately trained and experienced.

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3. Risk to patients and children born as a result of the proposed treatment services Focus

• The risks of fertility treatment to the health of patients and children born as a result of the activities proposed at the new centre

• Welfare of the Child – all assisted conception processes should only be conducted in a

manner that takes into account the welfare of any child that may be born as a result of treatment services

• Ensuring patients will receive treatment using the correct gametes or embryos –

patients should have confidence that the gametes or embryos used in their treatment are either their genetic gametes or embryos created with their gametes (or in the case of donor gametes that the gametes used are from the correct donor)

• Ensuring donor gametes will only be used where appropriate screening has taken

place – the health of patients and children, born as a result of treatment services, could be at risk if gametes from unscreened donors are used in the provision of treatment services

• Inspection themes 2010 - 2012 – the focus of inspection for 2010 – 2012 should include the following areas

• Witnessing

� Take account of the welfare of any child who may be born as a result of the proposed licensed treatment provided by the centre, and of any other child who may be affected by that birth (Principle 4). Evidence of how the centre demonstrates potential future compliance with this principle The centre has a standard operating procedure for assessing welfare of the child. What they could do better. No areas were identified.

� Conduct all proposed licensed activities with skill and care and in an appropriate environment, in line with good clinical practice, to ensure optimum outcomes and minimum risk for patients, donors and offspring (Principle 7).

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Evidence of how the centre demonstrates potential future compliance with this principle The centre has a standard operating procedure for all licensed activities. All staff are trained and competent to carry out licensed activities. At present the centre has three accredited consultants, with plans to recruit a fourth early next year. These consultants will be primarily based within the reproductive centre and each consultant will exclusively work within the reproductive centre one week in three/four. What they could do better. No areas were identified.

� Ensure that all premises, equipment, processes and procedures to be used in the conduct of licensed activities are safe, secure and suitable for the purpose (Principle 8). Evidence of how the centre demonstrates potential future compliance with this principle The premises were inspected before being handed over by the contractors and were therefore unequipped. The premises seemed appropriate for the centre’s activities and should provide a safe, clean and private environment for patients and centre staff. What they could do better. No areas were identified.

� Ensure that all staff engaged in the proposed licensed activity are competent and recruited in sufficient numbers to guarantee safe clinical and laboratory practice (Principle 9). Evidence of how the centre demonstrates potential future compliance with this principle The centre has a large number of staff, who are considered to be appropriately trained and experienced to carry out licensed activities. What they could do better. No areas were identified.

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� Will the new centre be able to report all adverse incidents (including serious adverse events and reactions) to the HFEA, investigate all complaints properly, and share lessons learned appropriately (Principle 11). Evidence of how the centre demonstrates potential future compliance with this principle The centre will report all adverse incidents to the HFEA. There are plans for regular team meetings were incidents will be discussed and HFEA alerts disseminated to all staff. What they could do better. No areas were identified.

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2. Patient Experience Focus

• Ensuring patients and donors will be treated fairly and that any treatment will be conducted in suitable premises by trained competent staff – treatment should only be carried out in licensed premises and staff must been trained and competent to perform their jobs. All patients and donors should be treated fairly and without discrimination

• Guaranteeing patients, patients, donors and partners’ independent decision

making – this should be done through the careful giving of appropriate and accurate information and the offering of counselling, and the subsequent taking and recording of effective consents

• Inspection themes 2010 - 2012 – the focus of inspection for 2010 – 2012 should

include the following areas

• Information about the cost of treatment (costed treatment plans) • Legal parenthood

� Treat prospective and current patients and donors fairly, and ensure that all licensed activities are conducted in a non-discriminatory way (Principle 1). Evidence of how the centre demonstrates potential future compliance with this principle This could not be assessed at this was an initial inspection. Though the centre does have a complaints policy. What they could do better. No areas were identified.

� Have respect for the privacy, confidentiality, dignity, comfort and well being of prospective and current patients and donors (Principle 2). Evidence of how the centre demonstrates potential future compliance with this principle There will be a large patient waiting area, and adjoining suite of dedicated consulting and ultrasound rooms, together with procedure rooms and two-stage recovery areas. In addition, the facility will provide a discreet suite of rooms for sample production away from thoroughfares. The reception area is screened to reduce conversations being heard by patients in the waiting area. There are sufficient consulting rooms and office pace so that patients may speak with staff in private.

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What they could do better. No areas were identified.

� Give future patients and donors sufficient, accessible and up-to-date information to enable them to make informed decisions (Principle 5). Evidence of how the centre demonstrates potential future compliance with this principle The centre has produced comprehensive patient information – this contains all the requirements set out in the HFEA Code of Practice. The centre plans to have a senior nurse, available each day, whose principle role will be to provide advice to patients who contact the centre. What they could do better. No areas were identified.

� Ensure that patients and donors will have provided all relevant consents before carrying out any licensed activity (Principle 6). Evidence of how the centre demonstrates potential future compliance with this principle The centre has standard operating procedures for obtaining consent. What they could do better. No areas were identified.

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3. Protection of embryos Focus • Safe procurement, processing, storage, application and disposal of gametes and

embryos – gametes and embryos will only be procured, processed, used, stored and disposed off in accordance with the law

� Provide respect for the special status of the embryo when conducting licensed activities (Principle 3). Evidence of how the centre demonstrates potential future compliance with this principle The Centre’s witnessing protocols have been audited against the tool provided by the HFEA. No non-compliances were apparent in the protocol. The Centre uses manual witnessing and have employed dedicated witnesses for laboratory processes. What they could do better. No areas were identified.

� Ensure that all premises, equipment, processes and procedures to be used in the conduct of licensed activities are safe, secure and suitable for the purpose (Principle 8). Evidence of how the centre demonstrates potential future compliance with this principle This could not be assessed as no equipment was in place at the time of the inspection visit. What they could do better. No areas were identified.

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4. Good governance and record keeping Focus

• Where gametes or embryos are used, complete and accurate information will be recorded and reported to the HFEA in a timely manner – incomplete and / or inaccurate information may lead to the wrong information being provided to offspring and / or researchers

• Ensuring gametes and embryos will be only stored in accordance with effective

consent and within the statutory timeframe

• Ensuring identifying information will only disclosed in accordance with consent

• Inspection theme 2010 - 2012 – the focus of inspection for 2010 – 2012 should include the following areas

• Patient consent to the disclosure of information, held on the HFEA register, for use in research

• Consent issues in relation to the storage of embryos (including cooling off period)

� Maintain accurate records and information about all licensed activities (Principle 10).. Evidence of how the centre demonstrates potential future compliance with this principle The centre has a quality manager and a quality management system. The assisted conception units at the Leeds General Infirmary (Centre 0052) and St James’s Hospital (Centre 0063) have jointly gained ISO 9001-2000 accreditation. All records and documents for the existing and new units are held on a separate, secure server (the ‘I’ drive) within the Trust IT system. Data is backed up according to Trust policy. The Unit has developed a ‘ghost I drive’ which contains all data and documents pertaining to the Leeds Centre for Reproductive Medicine. This drive will have restricted access until fully activated at a specific time after all staff have transferred and the current drives archived. The clinic uses an in-house database which is supported by IT staff. It is intended that this system will be expanded to cover all patient data and the eventual development of a paperless system. What they could do better. No areas were identified.

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� Conduct all licensed activities with regard for the regulatory framework governing treatment and research involving gametes or embryos within the UK, including: • maintaining up-to-date awareness and understanding of legal obligations responding

promptly to requests for information and documents from the HFEA, co-operating fully with inspections and investigations by the HFEA or other agencies responsible for law enforcement or regulation of healthcare (Principle 13).

Evidence of how the centre demonstrates potential future compliance with this principle The centre submitted all necessary information to support its application for a treatment and storage licence. With the change in regulation and arrangements for private services and the change in premises, the Leeds Teaching Hospitals NHS Trust and Genesis (the Consultants’ Limited Liability Partnership providing care to private patients) are in the process of applying for registration with the quality Care Commission. What they could do better. No areas were identified.

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