Inspection Report - Microsoft...Inspection details: The report covers the pre-inspection analysis, the visit and information received from the centre between 26 July 2011 and 24 May

Date of Inspection: 19 March 2013 Purpose of inspection: Renewal of Treatment and Storage Licence Length of inspection: 10 hours Inspectors: Susan Jolliffe, Andy Glew, Bhavna Mehta, Victoria Mills. Chris Hall (audit), Emer O’Toole (audit). Inspection details: The report covers the pre-inspection analysis, the visit and information received from the centre between 26 July 2011 and 24 May 2013. Date of Executive Licensing Panel: 07 June 2013. Purpose of the Inspection Report The purpose of the inspection is to assess whether centres are complying with the Human Fertilisation and Embryology (HF&E) Act 1990 (as amended), the Human Fertilisation and Embryology (HF&E) Act 2008 and the Code of Practice, to ensure that centres are providing a quality service for patients. 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 Authority’s Licence Committee/ Executive Licensing Panel which makes the decision about the centre’s licence renewal application. Centre details Centre name London Fertility Centre Centre number 0088 Licence number L/0088/17/f Centre address 53 Portland Place London W1B 1QJ Person Responsible Dr Magdy Asaad Licence Holder Madeleine Delaney Date licence issued 31 August 2009 Licence expiry date 31 August 2013 Additional conditions applied to this licence

None

Inspection Report

Executive Licensing Panel Papers 21 June 2013

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Contents Page Centre details. ........................................................................................................................ 1 Contents. ................................................................................................................................. 2 Report to Executive Licensing Panel. .................................................................................. 3

Brief description of the centre and its licensing history Activities of the centre Summary for licensing decision Recommendation to the Executive Licensing Panel

Details of inspection findings. .............................................................................................. 6

Protection of patients and children born following treatment Patient experience Protection of embryos Good governance and record keeping Changes / improvements since the last inspection

Areas of practice that require the attention of the Person Responsible and the Person Responsible’s response to these findings ........................................................... 29

Critical area of non compliance Major area of non compliance Other area of practice that requires consideration


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Report to Executive Licensing Panel Brief description of the centre and its licensing history: London Fertility Centre has been licensed by the HFEA since May 1992. The centre had a change of ownership in March 2010 when it became part of the Spire Healthcare Group. In December 2011 the centre’s research licence R0169/4/e expired and an application for renewal of the licence was not received. A new Licence Holder was appointed by the Executive Licensing Panel on 18 April 2013. The centre offers a full range of fertility treatment to self funding patients, including pre-implantation genetic screening or diagnosis (PGS / PGD) Activities of the Centre:

Type of treatment Number of treatment cycles

for 01 Mar 2012 - 28 Feb 2013

In vitro fertilisation (IVF) 463 Intracytoplasmic sperm injection (ICSI 324 Frozen embryo transfer (FET) 106 Donor insemination (DI) 33 Egg donation (non egg share) 23

Other licensable activities or Not applicable (N/A) Storage of eggs Storage of sperm Storage of embryos Research N/A

Outcomes* For IVF/ICSI, HFEA held register data for the period December 2011 to November 2012 show' the Centre’s success rates are in line with national averages with the following exceptions:

• The clinical pregnancy rate per cycle for Frozen Embryo Transfer (FET) in those aged 39 years and above is significantly higher than the national average.

In 2011 the centre reported 77 cycles of partner insemination with 6 pregnancies. This equates to an 8% pregnancy rate which is consistent with the national average. *The data in the Register may be subject to change as errors are notified to us by clinics, or picked up through our quality management systems.


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Summary for licensing decision – post review of draft by PR In considering overall compliance, the inspection team 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 PR is suitable and has discharged his duty under section 17 of the HF&E Act 1990 (as amended)

• the premises are suitable • the practices are suitable • the centre has submitted appropriately completed documentation in

accordance with General Direction 0008, in application for renewal of their licence

• the centre has submitted an application fee to the HFEA in accordance with requirements

The Executive Licensing Panel is asked to note that at the time of the inspection there were a number of areas of practice that required improvement, including two critical areas of non-compliance, three major areas of non-compliance and eight ‘other’ areas of non-compliance or areas of poor practice. Since the inspection visit the PR has provided evidence that the following recommendations have been fully implemented. Critical areas of concern:

• The PR should ensure that following sperm preparation, witnessing of the disposal of the container is performed by two members of staff and a record of the witnessing step is retained in the patient’s records.

Major areas of non compliance:

• The PR should ensure that all critical equipment is validated. • The PR should ensure that critical equipment is cleaned regularly and recorded

accordingly. • The PR should ensure that the multiple birth minimisation strategy is reviewed

to ensure that the centre works efficiently towards meeting the current multiple birth rate of 10% and that in cases where more than one embryo is transferred into to a woman who meets the criteria for single embryo transfer, the reason why more than one embryo has been transferred should be documented in the patients record.

Other areas of practice that require improvement:

• The PR should ensure that quality indicators are established for counselling. • The PR should ensure that there is an Standard Operating Procedure (SOP) to

be followed when; providing information to patients before providing consent to use of their

gametes in training; the process to follow for the legal parenthood provisions are required;


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• The PR should ensure that the test tubes and egg collection dish are appropriately labelled during egg collection, or should ensure the practice is risk assessed.

• The PR should ensure that there is a review of procedures for submitting patients’ consent to disclosure to researchers to the HFEA.

The PR has given a commitment to fully implement the following recommendations: Critical areas of concern:

• The PR should ensure that no gametes or embryos are kept in storage for longer that the consented period.

Other areas of practice that require improvement:

• The PR should ensure that all diagnostic tests are carried out in an appropriately accredited laboratory.

• The PR should ensure that it is a condition of all written agreements with third parties, that they will meet the requirements of the relevant licence conditions and the guidance set out in the HFEA Code of Practice.

• The PR should ensure that an audit of confidentiality and privacy is undertaken every two years.

• The PR should ensure that all licenced treatment activity is reported to the Authority within the timeframe required.

Recommendation to the Executive Licensing Panel The inspection team recommend the renewal of the centre’s licence for a period of four years without additional conditions subject to compliance with the recommendations made in this report being implemented within the prescribed timescales. Should the centre not provide satisfactory evidence that the recommendations are addressed within the agreed timescale, the inspection team recommend a further inspection be undertaken and a report of those findings be presented to the Executive Licensing Panel or Licence Committee, as appropriate.


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Details of inspection findings 1. Protection of patients and children born following treatment Focus The purpose of the inspection was to assess whether the centre:

• conducts all 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

• takes into account the welfare of any child who may be born as a result of the licensed treatment provided by the centre, and of any other child who may be affected by that birth

• ensures that all premises, equipment, processes and procedures used in the conduct of licensed activities are safe, secure and suitable for the purpose

• reports all adverse incidents (including serious adverse events and reactions) to the HFEA, investigates all adverse incidents and shares lessons learned.

► Witnessing and assuring patient and donor identification (Guidance Note 18) What the centre does well. The following laboratory activities were observed in the course of the inspection: egg collection, sperm preparation and Intracytoplasmic sperm injection. All of the procedures observed were witnessed in accordance with HFEA requirements using a manual witnessing system with the two exceptions noted below. The inspection team were able to review nine sets of witnessing records and concluded that records of manual witnessing are maintained in accordance with standard licence condition (SLC) T71. Electronic witnessing has recently been introduced. The system is being used for semen preparation initially and will continue to be run alongside manual witnessing until validation is completed before being implemented for all witnessing steps (SLC T24). There is a standard operating procedure (SOP) for witnessing procedures in place (SLC T 33 b). Audits of compliance with witnessing requirements are performed annually. A report of a witnessing audit of patient records in 2012 and 2013 was seen on inspection and demonstrated that corrective action had been identified and implemented (SLC T36).


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What the centre could do better. The tubes and dishes used during egg collection are not marked with patient identifiers (SLC T101). The tubes are used to transfer eggs within follicular fluid from the theatre to the laboratory. The aspirate is then transferred to dishes marked with the appropriate patient identifiers. See recommendation 2. The inspection team were able to observe sperm preparation in the laboratory, it was noted that the disposal of the container was not witnessed by a second member of staff in accordance with CoP 18.4(j) (SLC T71).

► Patient selection criteria and laboratory tests • Procuring, processing and transporting gametes and embryos (Guidance

Note 15) • Counselling (Guidance Note 3)

What the centre does well. Procuring, processing and transporting gametes and embryos: Guidance Note 15 Justification for the use of gametes and embryos in treatment, based on the patient’s medical history and therapeutic indications, was seen to be documented in the patient notes reviewed on inspection (SLC T49). An audit of 10 patient records conducted on inspection demonstrated that patients are screened for HIV, Hepatitis B, Hepatitis C and Anti-HBc as required by SLC T50. Screening results of satellite and transport patients are reviewed prior to treatment at the centre. Laboratories undertaking diagnosis and investigation of patients are accredited by the Clinical Pathology Accreditation (UK) Ltd. (CPA), with one exception detailed on page 14. Counselling: Guidance Note 3 The centre advocates and offers counselling to all patients and partners prior to them consenting to licensed treatment (SLCs T60 and T61). The importance of counselling and how to access it are documented in patient information sheets and a verbal offer of counselling is made and documented in the medical notes (SLC T58f). Satellite patients are given the option of having counselling provided at the secondary centre or at the centre. Counselling is provided in a comfortable and confidential environment by an experienced counsellor (SLCs T17 and T60). Patients interviewed at inspection were aware of the availability of counselling. The centre has SOPs which describe the counselling service processes (SLC T33b).The counsellor discussed outcomes of


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the most recent audit of the counselling services showing a high level of satisfaction with the service (SLC T36). Provision is available at the centre to refer patients requiring counselling for PGS / PGS if required. What the centre could do better. Counselling: Guidance Note 3 The centre has not established quality indicators for counselling (SLC T35). See recommendation 6

► Donor recruitment, assessment and screening (Guidance Note 11) Payments for Donors (Guidance Note 13) Donor assisted conception (Guidance Note 20) What the centre does well. Donor recruitment, assessment and screening: Guidance Note 11 A review of the relevant SOPs and discussions with staff, indicate that donor recruitment, screening and assessment practices are compliant with requirements. An audit of five donor records on the day of the inspection found that laboratory test results indicated that all required screening was conducted (including additional tests where required). Payments for donors: Guidance Note 13 The reimbursements made to donors are restricted to expenses incurred in the UK. All claims are verified in accordance with the centre’s protocol. This protocol and the patient information sheet regarding reimbursement were reviewed on inspection and were found to be compliant with the requirements of General Direction 0001. Donor assisted conception: Guidance Note 20 All donated gametes used in treatment are from identifiable donors (SLC T54). Records of donor gamete usage are kept which allow the centre to provide donors with information, if requested, regarding the number of persons born as a result of their donation, their sex and their year of birth (HF&E Act 1990 (as amended), Section 31 ZD (3)). What the centre could do better. Nothing noted at the time of this inspection.


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► Good clinical practice • Quality management system (Guidance Note 23) • Traceability (Guidance Note 19) • Validation (Guidance Note 15) • Equipment and materials (Guidance Note 26) • Premises – suitability of the premises and air quality (Guidance Note 25) • Adverse incidents (Guidance Notes 27) • Third party agreements (Guidance Note 24) • Intracytoplasmic sperm injection (ICSI) (Guidance Note 21)

What the centre does well. The quality management system: Guidance Note 23 The centre has a quality management system (QMS) that is accessible electronically and contains a quality manual and SOPs (SLC T33 a and b) which are regularly reviewed and document controlled (SLC T34). The quality manual was recently updated (version 5 approved in February 2013), the quality manual is well organised and referenced in accordance with good practice. (SLC T33). A sample of quality indicators were seen, including those for the provision of information, consent, welfare of the child and submission of data to the HFEA (SLC T35). Documentation provided demonstrated a comprehensive schedule of audits across key licensed activities against SOPs and regulatory requirements (SLC T36). Traceability: Guidance Note 19 There are procedures in place to ensure the traceability of all gametes and embryos and the consumables, reagents and equipment that come into contact with them (SLC T99). Containers used in the course of procurement and processing of gametes and embryos were observed on inspection to be marked with the full name of the patient and two further identifiers. With the exception noted on page 6 of this report. The centre’s traceability procedure is documented in a SOP (SLC T33 (b)). The laboratory manager demonstrated the centre’s database which is used to record consumable and reagent traceability data, including the supplier, product description and batch number (SLC T99). Four consumables in use in the laboratory were cross referenced to the centre’s database at inspection; no discrepancies were noted. Traceability audits are performed regularly, including physical audits of consumables in use in the laboratory against those recorded as being in use (SLC T36).


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Process validation: Guidance Note 15 The centre’s critical processes have been validated in compliance with SLC T72. A selection of validation documents were reviewed on inspection, including those for embryo transfer, IVF, ICSI, and cryopreservation. Critical gamete and embryo procurement and processing procedures were validated in July 2010, and are currently being reviewed using a retrospective analysis of the centre’s own data. Equipment and materials: Guidance Note 26 The laboratory manager provided documented evidence that all equipment that affects critical processing or storage parameters is subject to monitoring, alerts and alarms. Defined temperature limits have been set for temperature sensitive equipment and the centre’s monitoring system for dewars, incubators and refrigerators will alarm if the measurements are outside of these limits. The centre has an on-call rota for responding to alarms out of hours. Further monitoring of critical equipment, including frequent temperature mapping of incubators and heated stages is also performed (SLC T24). Evidence was provided that critical measuring equipment, including thermometers, are calibrated against national standards (SLC T24). The centre has documented procedures for the operation of all critical equipment (SLC T27) and a planned preventive maintenance programme has been established. Service records for a selection of critical equipment were reviewed and demonstrated that the selected equipment had all been serviced within the last year (SLC T24). Critical equipment has been validated, with one exception noted below (SLC T28). Validation records were reviewed for the electronic witness system, which has been introduced initially for only semen preparation, and will continue to be run alongside manual witnessing until validation is completed (SLC T24). The laboratory manager confirmed that revalidation of equipment following repair is performed; no equipment has required revalidation since the last inspection (SLC T25). Staff were able to confirm that sterile instruments and devices are used in gamete and embryo procurement and processing procedures (SLC T28). All devices are ‘CE’ marked (SLC T30). Premises and facilities: Guidance Note 25 A tour of the centre confirmed that all licensed activities are carried out on licensed premises. Patient records at Cozens House, which is owned by the centre but used for consultation only, are stored securely in locked cabinets, in rooms with restricted access for staff only (SLC T1). The premises were considered by the inspection team appropriate for the activities undertaken there (SLC T17).


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Documented evidence was provided to demonstrate that the processing of gametes and embryos takes place in an environment of at least grade C air quality in the critical work area and a background air quality of at least grade D (SLC T20). The centre has a dedicated, secure cryostorage room for the dewars used to store cryopreserved gametes and embryos. Adverse incidents: Guidance Note 27 The centre is compliant with HFEA requirements for incident reporting. The centre has an incident reporting SOP (SLC T33b) and discussions with centre staff indicated they understood the importance of reporting and investigating incidents appropriately (SLC T119). A review of the centre’s incident log against HFEA records confirmed that all HFEA reportable incidents had been reported (SLC T118). Third party agreements (TPAs): Guidance Note 24 The centre has developed TPAs where necessary with its suppliers. (SLC T111). A list of TPAs was available on inspection (SLC T115) a sample of five TPAs were reviewed on inspection and found to be compliant with SLC T114, but not with SLC 116, as described below. . Satellite and transport centre management: Guidance Note 24 The centre has no transport centres, and from 01 April 2013 the centre has 12 satellite centres, 10 Spire group hospitals and two non Spire group hospitals. The agreements in place for the 12 satellite clinics were reviewed at the inspection, and included the process by which the satellite centres should meet the requirements of General Direction 0010. What the centre could do better. Equipment and materials: Guidance Note 26 Critical equipment has been validated, however the new ICSI Research Instrument, which was introduced in November had not been validated 2012 (SLC T28). See recommendation 4. A log recording the regular cleaning and decontamination of equipment in the laboratory and clinical areas was observed. On checking the log and corresponding equipment, the log showed that the incubator was due to be cleaned monthly, but the log was completed last in December 2012 (SLC T26). The monthly cleaning log for the incubator had not been completed for January or February 2013 (SLC T26). See recommendation 4. Third party agreements: Guidance Note 24 The third party agreements in place, do not make it clear that the third party will meet the requirements of the relevant licence conditions and the guidance set out in the HFEA Code of Practice (SLC T116) See recommendation 7.


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►Multiple Births (Guidance Note 7) What the centre does well In 2010/11 the centre’s multiple clinical pregnancy rate for all IVF, ICSI and FET cycles for all age groups was 26%: this represented performance that was not likely to be statistically different from the 20% live birth rate target. The PR has provided sufficient evidence to demonstrate partial compliance with HFEA Directions 0003 in that: • staff at the centre have audited their strategy and protocols as part of the quality

management audit programme; • staff have maintained a log of women receiving double and triple embryo

transfers who meet the criteria for single embryo transfer; What the centre could better For the time period April 2011 to September 2012 the centre’s multiple clinical pregnancy rate for all IVF, ICSI and FET cycles for all age groups was 27%: this represents performance that is likely to be statistically different from 15% live birth rate target. The PR has not provided sufficient evidence to demonstrate compliance with HFEA Directions 0003 in that:

• he was not able to adequately demonstrate the centre’s progress towards reducing their multiple pregnancy rates and subsequent multiple birth rates;

• staff have not maintained a log which indicates the reasons for variation from the centre’s single embryo transfer policy and outcomes which are also recorded in the patient record in all cases;

On inspection, an audit of nine patient records showed that four records did not state a reason for transferring more than one embryo into a woman who meets the single embryo transfer criteria. There was no explanation in the patient’s records confirming that the risks associated with multiple pregnancy had been fully discussed. See recommendation 5. 2 The HFEA use a conversion factor of 1.27 to convert the multiple live birth rates (MLBR) target to a multiple clinical pregnancy rate (MCPR) target. The 2010/11 MLBR target of 20% is calculated as equivalent to a MCPR of 25%: the 2011/12 MLBR target of 15% is calculated as equivalent to a 19% MCPR.


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► Staff engaged in licensed activity • Person Responsible (Guidance Note 1) • Staff (Guidance Note 2)

What the centre does well. The PR has given assurance that staff are suitably qualified to carry out licensed activities and associated services. All staff, where registered with the relevant professional and/or statutory bodies. Person Responsible (Guidance Note 1) The PR Mr Magdy Asaad MB BCh has held the position of PR at the centre since 2008, and has academic qualifications in the field of medicine as required by the HF&E Act 1990 (as amended) section 16(2)(c)(i) and (ii) and has more than two years of practical experience which is directly relevant to the activity to be authorised by the licence. The PR has successfully completed the HFEA Person Responsible Entry Programme (PREP number T/1051/7). Staff (Guidance Note 2) The centre has an organisational chart within the QMS which defines accountability and reporting relationships (SLC T11). Evidence was provided that staff are appropriately accredited, qualified and registered (SLCs T12 and T14). The PR is the Clinical Director for the centre, supported by a quality lead and clinical governance lead. (SLCs T14 and T16). Counselling is provided by a qualified and experienced counsellor, who is a senior accredited member of the British Infertility Counselling Association (BICA). The centre has policies to support induction training and competence assessment, professional development and annual performance appraisal (SLCs T12 and T15). Nursing and laboratory staff provided evidence of an induction programme for new staff which included a corporate induction followed by a local induction. Nursing and laboratory staff records showed documented evidence of on-going assessment of core competencies and attendance at study days (SLC T12 and T15a). What the centre could do better. Nothing noted at the time of this inspection.


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► Welfare of the Child (Guidance Note 8) What the centre does well. The inspection team concluded that before providing treatment, the centre takes into account the welfare of the child (WoC) who may be born as a result of treatment and of any other child who may be affected by that birth (SLC T56). This conclusion was based on a review of eight sets of patient records all of which contained a WoC assessment (SLC T46e). The patient records showed that the WoC assessment process is documented and is applied to all patients, including all those participating in surrogacy arrangements (SLC T56). The WoC assessment process is subjected to monitoring and an annual audit of patient records, the last audit in December 2012 showed that 79 files had been reviewed and a 100% compliance was achieved for WOC assessment (SLC T35 and T36 What the centre could do better. Nothing noted at the time of this inspection.

► Embryo Testing • Preimplantation genetic screening (Guidance Note 9) • Embryo testing and sex selection (Guidance Note 10)

What the centre does well. The centre is licensed for embryo testing and offers both Preimplantation genetic diagnosis (PGD) and Preimplantation genetic screening PGS. The centre’s embryo biopsy procedures are documented in SOPs, which have been reviewed in the last 12 months (SLC T33b). Quality indicators have been established for biopsy procedures, and corrective action taken where expected performance has not been achieved. The SOP for biopsy procedures was reviewed in November 2012 (SLC T35 and T36). The centre’s PGD log for 2012 was reviewed on inspection and demonstrated that PGD testing was only performed for genetic conditions that have been authorised by the Authority. The centre’s PGD checklist includes confirming if the condition has been approved by the Authority prior to commencing the treatment cycle (SLC T89).


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The laboratory manager confirmed that no sex selection for social reasons is conducted at the centre. The sex of the embryo is not included in the report from the external genetic testing laboratory unless it is required for sex-linked conditions (SLC T88b). Evidence of competence assessment for staff performing embryo biopsy was reviewed on inspection (SLC T15a). An external laboratory is used to undertake the genetic analysis of material for PGD and PGS. The third party agreement with the laboratory was reviewed and is compliant with requirements (SLC T111, T114 and T116). All donor screening tests are undertaken in a Spire Healthcare CPA-accredited pathology laboratory (SLC T53a) What the centre could do better. The centre uses an external laboratory for the diagnostic genetic analysis for embryo testing. This laboratory is in the process of obtaining CPA accreditation, and the centre had confirmation that a CPA inspection is arranged for August 2013 (SLC T21). See recommendation 10.


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2. Patient Experience Focus The purpose of the inspection visit was to assess whether the centre: • treats prospective and current patients and donors fairly, and ensures that all

licensed activities are conducted in a non-discriminatory way • has respect for the privacy, confidentiality, dignity, comfort and well being of

prospective and current patients and donors • gives prospective and current patients and donors sufficient, accessible and up-

to-date information to enable them to make informed decisions • ensures that patients and donors have provided all relevant consents before

carrying out any licensed activity

► Treating patients fairly • Treating patients fairly (Guidance Note 29) • Confidentiality and privacy (Guidance Note 30) • Complaints (Guidance Note 28) • Provision of costed treatment plans (Guidance Note 4) • Egg sharing arrangements (Guidance Note 12) – not applicable • Surrogacy (Guidance Note 14)

What the centre does well. Treating patients fairly: Guidance Note 29 The PR reported that there are various policies in place regarding the fair treatment of patients, which ensure that licensed activities must be conducted in a non-discriminatory manner and that careful consideration is given as to how the centre may meet the needs of individual patients and their circumstances. Confidentiality and privacy: Guidance Note 30 A tour of the centre demonstrated that access to registers; data and patients records are restricted to authorised personnel. Key pad entry is used for access to non-patient areas in the centre. Areas where personal conversations and consultations may occur were seen to be private. The main medical record store room had a keypad lock and was considered by the inspection team to be appropriately secure (SLC T17). Complaints: Guidance Note 28 Complaints are processed in a manner compliant with CoP Guidance Note 28. The centre has a complaints policy and record log. Information on how service users may make a complaint is available to patients (CoP Guidance 4.2k).


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Provision of costed treatment plans: Guidance Note 4 Discussions with staff indicated that patients and their partners are provided with clear written information by the treating clinician about their proposed treatment and its anticipated costs (CoP Guidance 4.3). Detailed information regarding treatment costs is also available from the centre’s website. Surrogacy: Guidance Note 14 The centre does offer surrogacy treatment, and all participants in surrogacy arrangements are subjected to WoC assessment (SLC T56). The gamete providers are screened as donors in accordance with SLC T52, and registered in accordance with Directions 0001. What the centre could do better. Confidentiality and privacy: Guidance Note 30 In the last two years, the centre has not audited how far the confidentiality and privacy procedures comply with the approved protocols, the regulatory requirements and quality indicators (SLC T36). See recommendation 11.

► Information • Information to be provided prior to consent (Guidance Note 4) • Information about storage of embryos (including cooling off periods) • Information about Intracytoplasmic sperm injection (Guidance Note 21) • Information about preimplantation genetic testing (Guidance Notes 9 &

10) • Information about legal parenthood (Guidance Note 6)

What the centre does well. Information to be provided prior to consent (Guidance Note 4) The centre has an SOP for information provision to patients (SLC T33b). All prospective patients are invited to an initial consultation session to discuss any aspect of treatment and enable them to look around the centre. When treatment commences, patients are given an information pack containing all documentation relevant to their treatment pathway, including all required consent forms. Patients are asked to review the literature and to complete the relevant consent forms once discussed at the second consultation. Patient information was reviewed on inspection and was found to be compliant with CoP requirements and to provide detailed information about the treatments available, their consequences and risks, consent, and the availability of counselling (SLCs T58 and T60).


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Information about storage of embryos (including cooling off periods) Review of the written information indicated that patients are provided with appropriate information about gamete and embryo storage (SLCs T58 and T84; CoP Guidance 17.11, 17.12, 17.14). Information is also provided regarding the gamete provider’s right to vary or withdraw their consent to storage and how this can be achieved (SLC T58). Information about Intracytoplasmic sperm injection (ICSI) (Guidance Note 21) Discussion with staff and review of written patient information indicated that patients and their partners are given specific information about ICSI which discusses the process and the associated risks (CoP Guidance 21.1 and 21.2). Information about preimplantation genetic testing (Guidance Notes 9 & 10) Patient information explained the nature of the treatment, its consequences and risks (SLC T58). Information about legal parenthood (Guidance Note 6) The nursing staff and counsellor interviewed during the inspection demonstrated a good understanding of legal parenthood requirements (SLC T61 – T65). Information packs provided to recipients of donated gametes contain information about parenthood provisions (SLC T60 and T61).

What the centre could do better. Information to be provided prior to consent (Guidance Note 4) The centre does not have a SOP for the process to be followed when providing information to patients before providing consent to use of their gametes in training (SLC T33b). See recommendation 8. Information about legal parenthood (Guidance Note 6) The centre does not have a SOP to follow for taking consent to parenthood before treating a woman with donor sperm or embryos (SLC T33b). See recommendation 8.

► Consent • Consent to treatment, storage, donation, training and disclosure of

information (Guidance Note 5) • Consent to legal parenthood (Guidance Note 6)

What the centre does well. Consent to treatment, storage, donation, training and disclosure of information (Guidance Note 5) Staff at the centre provided evidence to demonstrate that appropriate written consent is obtained from patients by suitably qualified and competent staff before gametes or embryos are used in treatment or stored (SLC T57). Consent for the satellite patients is obtained at the satellite centre.


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Consents are taken from patients in nurse consultations after written information has been provided and patients have been offered counselling and an opportunity to ask questions (SLC T57 and T58). Photographic identification is used to verify patient identity. Copies of photographic identification were seen in the patient notes reviewed on inspection (CoP Guidance 5.10). The consent taking processes are described in clinical SOPs (SLC T33b). The centre has a quality indicator in place for consent form completion which is audited (SLC T35 and T36). Assessment of staff competence to take consent has been documented (SLCs T12 and T15a). A sample of eight sets of medical records from patients and donors undergoing various treatments (IVF, FET, sperm donation, and DI), demonstrated that all contained correctly completed treatment and storage consent forms (SLC T57). Consent to legal parenthood: Guidance Note 6 Information regarding legal parenthood is given to patients prior to treatment; Medical staff explained the process that would be followed if consent to parenthood was withdrawn, the centre could not recall a case where a partner had withdrawn consent (SLCs T64 and T65). What the centre could do better. Nothing noted at the time of this inspection.


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3. Protection of gametes and embryos Focus The purpose of the inspection was to assess whether the centre has respect for the special status of the embryo when conducting licensed activities

► Legal Requirements [Human Fertilisation and Embryology Act 1990 (as amended)]

• Licensed activities only take place on licensed premises • Only permitted embryos are used in the provision of treatment services • Embryos are not selected for use in treatment for social reasons • Embryos are not created by embryo splitting • Embryos are only created where there is a specific reason to do so which

is in connection with the provision of treatment services for a particular woman

• Embryos are only stored if those embryos were created for a woman receiving treatment services or from whom a third party agreement applies

• Embryos which are or have been stored are not given to a person, other than in the course of providing treatment services, unless that person is a person to whom a licence applies

• No money or other benefit is given or received in respect of the supply of gametes or embryos unless authorised by the Authority

What the centre does well. The inspection team consider that following discussions with centre staff and a review of documentation and records relating to imported gametes, no money or benefit is given or received for the supply of gametes except where authorised by the Authority. Donor compensation records indicated that compensation paid to donors is within the prescribed limits of General Direction 0001. What the centre could do better. Nothing noted at the time of this inspection.

► Storage of gametes and embryos • Storage of gametes and embryos (Guidance Note 17) –

What the centre does well. The centre has SOPs detailing the procedures for storing gametes and embryos (SLC T33b). The laboratory manager stated that storage audits are performed every two years and the report of the last audit, performed in November 2011, was


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reviewed on inspection. Corrective action was identified, and an action plan to address the issues is being implemented (SLC T36). What the centre could do better. A review of the centre’s records of consent to storage of gametes and embryos on inspection showed that 38 samples are being stored after the expiry of their consented storage period (HF&E Act 1990 (as amended) Sch 3, 8 (1) and 8 (2)). See recommendation 1.

► Distribution and / or receipt of gametes and embryos • Distribution of gametes and embryos (Guidance Note 15) • Export of gametes and embryos (Guidance Note 16) Receipt of gametes

and embryos (Guidance Note 15) • Import of gametes and embryos (Guidance Note 16)

What the centre does well. The centre has imported and exported sperm and embryos since the last inspection. The notes of two sets of patients who had samples exported in January 2013 were reviewed and included details required by the General Direction 0006. The centre had also imported donor sperm from America and Denmark. Confirmation that the requirements of General Direction 0006, schedule 3 were satisfied for the import of sperm from America was reviewed and found to be comprehensive. The centre’s procedures for the distribution of gametes and embryos using transport incubators and dry shippers are supported by an SOP and checklists (SLC T110), including the action to be taken if a recall of material is required.

What the centre could do better. Nothing noted at the time of this inspection.


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► Use of embryos for training staff (Guidance Note 22)

What the centre does well. Embryos are used for staff training at the centre. Once the gametes and embryos have been designated as not for treatment purposes, the training consent is checked and material moved to a dedicated area (SLC T93). Staff interviewed demonstrated a clear understanding of the purposes for which embryos could be used for training purposes (SLC T93). The centre’s patient information clearly describes how gametes and embryos will be used to train staff and includes the requirements of SLC T97. The centre had an SOP for the consent to training, this covered the process by which it is assured that embryos donated for training purposes are not used in treatment ( SLC T 92), and the procedure to ensure that no actual or perceived conflict of interest between the use of embryos in the provision of treatment services (SLC T95). What the centre could do better. Nothing noted at the time of this inspection.


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4. Good governance and record keeping Focus The purpose of the inspection was to assess whether the centre: • maintains accurate records and information about all licensed activities • conducts all licensed activities with regard for the regulatory framework

governing treatment involving gametes and embryos within the UK, including o maintaining up-to-date awareness and understanding of legal

obligations o responding promptly to requests for information and documents from

the HFEA o co-operates fully with inspections and investigations by the HFEA or

other agencies responsible for law enforcement or regulation of healthcare

► Record keeping • Record keeping and document control (Guidance Note 31)

What the centre does well. All patient records reviewed on inspection were clear, legible, well organised and complete (SLC T46). Each record was seen to include the patient’s first name, surname, date of birth, age and sex. Details of how the patient had been identified by staff were also evidenced in the records, with a copy of the passport as identification. Patient’s notes included details of the services provided to them, a medical history and relevant documented consents, laboratory data and the results of tests carried out (SLC T46). The centre has procedures in place to ensure that records are protected and are retained and readily retrieved (SLC T47). A system has been established to archive records for a minimum of 30 years (SLC T48). What the centre could do better. Nothing noted at the time of this inspection.

► Legal requirements [Human Fertilisation and Embryology Authority 1990 (as amended)] • Obligations and reporting requirements of centres (Guidance Note 32)

What the centre does well. The PR provided all information required by the application process prior to


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inspection. Centre staff cooperated fully with the inspection team and all further information requested for the inspection was provided in a timely manner. To determine whether all licenced treatment activity is reported to the HFEA and within required timescales, a sample of treatments undertaken over a 12 month period and recorded within the centres laboratory records was compared to data submitted by the centre for inclusion on the HFEA register. All donor insemination (DI) treatments and 122 of 123 IVF treatments within the audit sample had been reported to the HFEA as required by Direction 0005. What the centre could do better. One of 123 IVF treatments in the audit sample had not been reported at the time of inspection. The audit demonstrates failings in the clinic’s reporting procedures to the HFEA which may indicate that other treatments may not have been reported in accordance with Direction 0005. A significant proportion (over 60%) of the licensed treatment data in the audit sample has been submitted to the HFEA outside the time period required by Direction 0005. See recommendation 13.

► Disclosure of information • Confidentiality and privacy (Guidance Note 30) • Disclosure of information, held on the HFEA Register, for use in research

What the centre does well. Confidentiality and privacy (Guidance Note 30) Discussions with staff, a review of information submitted prior to inspection and a tour of the premises indicated that confidential patient information is not disclosed unless under circumstances permitted by law (SLC T43). Disclosure of information, held on the HFEA Register, for use in research The centre’s procedures for disclosing information are compliant with HFEA requirements, with the exception noted below. What the centre could do better. Confidentiality and privacy: Guidance Note 30 In the last two years, the centre has not audited how far the confidentiality and privacy procedures comply with the approved protocols, the regulatory requirements and quality indicators (SLC T36). See recommendation11.


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Disclosure of information, held on the HFEA Register, for use in research A sample of 15 completed patient and partner disclosure consents were reviewed against disclosure consent data supplied by the centre for inclusion on the HFEA register. In two instances a discrepancy was found between the consent decision recorded in the patient and her partner’s records and that submitted to the HFEA register. In both instances consent to the use of identifying register data for research purposes has been given, but the register records consent was withheld. See recommendation 12.


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5. Changes / improvements since the previous inspection on 26 July 2011 Area for improvement Action required Action taken as

evidenced during this inspection

Diagnostic testing of embryo biopsies is currently being performed in a non-CPA accredited laboratory (SLC T21)

The laboratory performing diagnostic embryo biopsy testing for PGS/PGD should be accredited by CPA (UK) Ltd or another body accrediting to an equivalent standard.

At inspection the centre confirmed that the laboratory is in the process of obtaining CPA accreditation, the CPA inspection is planned for August 2013. Further action required

Some critical processes & equipment have not been validated.(SLC T24 T72)

As this was an issue at the previous inspection the PR should ensure, without further delay, that appropriate validation of all critical processes and equipment is in place by 26 October 2011.

Information was sent to evidence that validation was in place post interim inspection. At this inspection the ICSI equipment required validation, this has since been completed.

The QMS has not been well maintained since March 2010, due to organisational and personnel changes. There are now outstanding issues relating to; • SOP development • Audits of practice • QI development • Document control which need to be addressed as a matter of urgency. (SLC T33b T36 T35 T34)

The PR should provide an action-plan and time-line for the implementation of all QMS improvements to the inspector by 26 October 2011.

Action plan received, the QMS system at this inspection was better organised. However two SOPs and one QI were outstanding post renewal inspection, this has been addressed.

Staffing, resource and training issues were identified during the course of the inspection. (SLC T12 T15)

The PR should assess present resources versus activity, to ensure that enough appropriately trained and competent staff are in post to provide safe treatment services. The PR should forward a report to the inspector, giving details of such

Following the interim inspection, the PR completed a ‘work activity matrix’ which showed that adequate resources were in place in the


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an assessment and any action points to be taken by 26 October 2011.

laboratory to safely deliver the level of treatment. No further action required.

The MBMS has not been reviewed or developed during the past eighteen months. (General Direction D0003)

The PR should ensure that data is retrieved from the centres database and used to review its present MBMS, prior to the updating of the strategy. A log of patients who were eligible for eSET, but who chose to have multiple embryos transferred should be updated and maintained. The PR should forward evidence to the inspector that the centre’s MBMS has been updated, based on the review of its own data, by 26 October 2011

The centre has recently revised their MBMS, and has maintained a log. At inspection it was found that patient records did not record the reason why more than one embryo was transferred in all cases.

During the review of the witnessing SOP, it was found that additional witnessing steps were required. (SLC T71)

The PR should ensure that the witnessing SOP is reviewed and amended to include areas highlighted within the report. Evidence that the SOP has been amended should be forwarded to the inspector by 26 October 2011.

The PR supplied a reviewed and amended witnessing SOP, post interim inspection. No further action required.

Current donor payments are not compliant with General Direction D0001. (General Direction D0001)

The PR should ensure that donor payments are compliant with General Direction D0001. Evidence that the centre’s procedure has been amended should be forwarded to the inspector by 26 October 2011.

Procedure reviewed and amended in line with General Direction D0001. No further action required

Information submitted to the Registry via the EDI system was found to be inaccurate. (SLC T9e)

The centre should ensure that information submitted to the HFEA is accurate at all times.

This issue remains unresolved. Further action required

The present gamete/embryo transportation SOP does not include information on temperature, time limits or actions to be taken in the event of a shipment recall. (SLC T107 G15C)

The PR should ensure that the transportation SOP is reviewed and amended to include information relating to temperature and time limits, and actions to be taken in the event of a shipment recall. Evidence that the SOP has been amended should be forwarded to the inspector by 26 October 2011.

Amended SOP received. No further action required.


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Some equipment SOPs reviewed do not include information concerning actions to be taken in the event of equipment malfunction. (SLC T27)

The PR should ensure that all equipment SOPs are reviewed and amended to include action points in the event of equipment malfunction.

Issue resolved No further action required.

When reviewed, the Centre’s website included inaccurate success rates. This was also an issue at the previous inspection

The PR should ensure that all patient information displayed on their website is accurate and compliant with Chairs letter CH(11)02.

Issue resolved No further action required.

During review it was discovered that some TPAs were not compliant with all required Licence Conditions. (SLC T116

The PR should ensure that all TPAs are compliant with all required Licence Conditions.

The TPA’s supplied at inspection were not compliant with all standard licence condition T116. Further action required.

It was observed that equipment and premises cleaning records are not being updated (SLC T26

The PR should ensure that cleaning records are accurately maintained.

Issue resolved post inspection. No further action required.

Cryopreserved semen samples for oncology patients are not being divided into different cryo-storage vessels. (G17.7)

The PR should ensure that cryopreserved semen samples for oncology patients are divided into different cryo-storage vessels.

Issue resolved pre inspection. No further action required


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

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

Area of practice and reference

Action required and timescale for action

PR Response Executive Review

1. Consent: To the storage of cryopreserved material. The centre had on 19 March 2013, 20 embryo samples and 18 sperm samples stored beyond the storage consent period, and without patient consent, contrary to HF&E Act 1990 (as amended) Schedule 3, 8 (1) and 8 (2 (SLC T79).

The PR must ensure that gamete and embryo samples are stored within the terms of the gamete provider’s consent and within the statutory storage periods. The PR should conduct an urgent audit of all stored gametes and embryos against the consent records held by the centre and provide a summary report to the HFEA documenting

The inspection visit was on 19th March and we received the report on 10th May. At the time of inspection I did ask that when the report is sent to us with actions to please allow us enough time to take the required actions. We do not consider that 20th of June is a realistic time frame to complete the required actions. We ask to extend that to 20th

The lead inspector is satisfied that progress is being made, and the target date of 20 July 2013 is acceptable, and will be monitored closely.


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the findings of the audit. The report should be submitted to the lead inspector by 20 July 2013. The centre should submit an action plan for the implementation of corrective actions to ensure effective consent is in place for all stored gametes and embryos. The PR is reminded that the centre should follow their documented procedures to ensure that all reasonable efforts have been made to contact the gamete providers prior to any disposal without consent. If there is possibility of legal challenge to the disposal of gametes then the PR should report this to the inspector: See guidance in Chair’s letter CH (03)03. http://www.hfea.gov.uk/2687.html The centre should review their bring forward procedures, a summary report of the review including corrective actions and

July. We will do our best to complete the requirements before that date. We have reviewed the bring forward policy and already introduced a new a new measure. Please note that as always LFC team has been very transparent with HFEA and its inspectors and we did highlight the main problems during the inspection, especially storage. We have identified that and were starting to work on it. I am sure the inspection team can confirm that.


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timescales for their implementation should be submitted to the lead inspector before 20 July 2013.

2. Witnessing The centre does not witness the disposal of the container following sperm preparation CoP 18.4(j) (SLC T71).

The PR should ensure that following sperm preparation, witnessing of the disposal of the remaining container is performed by two members of staff and a record of the witnessing step is retained in the patient’s records. This should be implemented immediately, and checked by an audit. Corrective actions should be implemented and the audit report and corrective action should be sent to the inspector by 20 June 2013.

This action has been implemented and audited. Attachments: 1. Semen assessment lab form (amended to include witnessing of container discard) 2. Audit of the disposal of container following sperm preparation.

12 June 2013 A copy of the amended semen assessment form was seen, showing an additional witnessing section. Audit of witnessing the disposal of the container following sperm preparation completed. A copy of the audit report showed that in 15 patient records there was a witness to the disposal of the container, therefore 100% compliance. No further action required.


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

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

• which indicates a major shortcoming from the statutory requirements; • which indicates a failure of the Person Responsible to carry out his/her legal duties • a combination of several “other” areas of non-compliance, none of which on their own may be major but which

together may represent a major area of non-compliance.

Area of practice and Reference



3. Validation The centre had purchased new laboratory equipment to perform ICSI, which had not been validated (SLC T28 and SLC 72).

The PR should ensure that the ICSI equipment is validated by 20 June 2013. A copy of the validation report should be sent to the lead inspector.

Completed. Attachments: 1.ICSI RH validation 2. Research Instruments

29 May 2013 the ICSI equipment was validated, supporting documents sent as requested. No further action required.

4. Equipment The centre had not completed the monthly cleaning log for January and February 2013, maintenance and cleaning of critical equipment must be performed regularly and

The PR should ensure that critical equipment is cleaned regularly and recorded. Corrective actions, for example training issues should be addressed and the inspector

Completed Attachments: 1. Cleaning lab record 2. Previous cleaning lab record 3. Cleaning lab audit (including corrective actions

12 June 2013 Copies of the completed cleaning log were sent. Training for staff has taken place and an audit was sent showing that the cleaning log is checked regularly for completeness.


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recorded accordingly (SLC T26)

informed of action taken, with a copy of an audit to show that the cleaning log is completed should be sent to the inspector by 20 June 2013.

No further action required.

5. Multiple Births The PR was unable to adequately demonstrate how the centre’s MBMS is being implemented in order to reduce the centre’s multiple pregnancy rate and subsequent multiple birth rate to meet the current target of 10%.(SLC T123) Where more than one embryo is transferred to a woman who meets the criteria for single embryo transfer, the reason why more than one embryo has been transferred should be documented in the patient’s record. ( Directions 0003)

The PR should review the multiple birth minimisation strategy to ensure that multiple births are minimised in accordance with the requirements of Directions 0003 and standard licence conditionT123. The revised strategy and a plan of how the PR intends to implement and monitor the efficacy of the strategy should be sent to the lead inspector by 20 June 2013 The PR should ensure that where more than one embryo is transferred to a woman, the reason why should be documented in the patients record and confirm that that the risks associated with multiple pregnancy have been

I have explained to the inspection team that a main factor in the higher multiple pregnancy rate is the effect of the non-Spire satellite clinics, as their doctors were performing ET themselves. They also did not have access to our data base system (IDEAS) so they could not document the reasons for transferring 2 embryos for someone who is eligible for eSET in LFC records. This has now changed, as currently all our satellite centres are Spire Clinics and our LFC team performs all the ETs. This means we now have control over number of embryos to transferand also the documentation. We have reviewed the MBMS and we do believe that it will work.

12 June 2013 A copy of the revised multiple birth minimisation strategy and action plan were sent by the PR, the lead inspector is satisfied that these meet the requirements of Directions 0003, and the PR is being pro-active in his progress to meet the 10% target. No further action required.


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fully discussed with the patient.

However, we will look at it again.

► Other areas of practice that requires improvement Areas of practice that requires improvement is any area of practice, which cannot be classified as either a critical or major area of non compliance, but which indicates a departure from statutory requirements or good practice.

Area of practice and reference



6. Counselling The centre has not established quality indicators for counselling. SLC T35

The PR should ensure that quality indicators are established for counselling, and these should be sent to the inspector by 20 June 2013.

Completed Attachments: 1.Counselling Key Performance Indicators 2. KPI LFC 2012

12 June 2013 The PR sent very comprehensive quality indicators for the counselling service. No further action required.

7. Third Party Agreement The centre has established written agreements with third parties who provide goods or services. The centre does not include a

The PR should ensure that it is a condition of all written agreements with third parties, that they will meet the requirements of the relevant standard licence conditions and the guidance set out in the

This is work in progress. We have amended the TPAs for our satellite centres to include SLC T116. The rest will follow and we aim to have them all in place by September. Attachment: A sample of a

12 June 2013 The PR has sent a TPA that does include the HFEA requirements, this shows an understanding and progress towards the target date of September 2013.


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condition of all agreements that the third party will meet the requirements of the relevant licence conditions and the guidance set out in the HFEA Code of Practice (SLC T116).

HFEA Code of Practice. The PR should inform the inspector when all the TPA’s are updated in line with the HFEA Code of Practice, a sample will then be requested by the inspector to review; this should be addressed by 20 September 2013.

satellite centre TPA

8. An SOP is required for; Consent to the use of gametes in training. The centre does not have an SOP for the process to be followed when providing information to patients before providing consent to use of their gametes in training (SLC T33b). Legal parenthood The centre does not have an SOP to follow for taking consent to parenthood before treating a woman with donor sperm or embryos (SLC T33b)

The PR should ensure that there is an SOP to be followed when; 1. Providing information to patients before providing consent to use of their gametes in training. 2. Taking consent to parenthood before treating a woman with donor sperm or embryos. A copy of both SOP’s and a training plan for staff should be sent to the inspector by 20 June 2013.

Attached; 1. Providing information to patients SOP. 2. Legal parenthood SOP.

12 June 2013 A copy of both SOP’s have now been received. No further action required.


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9. Traceability All containers (dishes, vials, ampoules, tubes etc.) at all stages of procurement, processing, use and storage of gametes and embryos should be labelled with the patient's/donor's full name and a further identifier or a uniquely identifying donor code (including labelling in the form of electronic tags) SLC T101

The PR should either ensure that the test tube and egg collection dish is appropriately labelled during egg collection, or should ensure the practice is risk assessed. A copy of the risk assessment and any corrective action should be sent to the inspector by 20 June 2013.

This practice has been risk assessed. Attachments: 1. Risk assessment report. 2. lab record 3. Lab record biopsy 4. OD/OR lab record 5. Oocyte freeze lab record

21 May 2013 a risk assessment was completed and the findings were; Laboratory data sheet will be amended so that an Embryologist and witness will sign that there are no tubes of follicular fluid left in the tube warmer at the end of the procedure. Collection dish and holding dish to be labelled with patient name and date of birth. Evidence of the corrective action taken was sent. No further action required.

10. CPA accreditation The centre uses an external laboratory that has not yet obtained accreditation from CPA (UK) Ltd or any other equivalent body (SLC T21).

The PR should ensure that all diagnostic tests are carried out in appropriately accredited laboratories. The PR should inform the inspector by 20 September 2013 that either accreditation has been achieved. Or, provide an update of alternative action to ensure

Reprogenetics, the genetic lab we use, has submitted all paperwork for CPA accreditation and has a reference number of 4021. It is expected that it will be inspected in August 2013. The lab also has a QMS that is overseen and audited by a professional Quality Manager. Additionally, Reprogenetics UK

The lead inspector has seen the letter confirming that Reprogenetics is scheduled for a CPA accreditation inspection in August. If this fails to either take place, or accreditation is not achieved, then the PR should provide an update of alternative action to ensure that the centre uses an


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that the centre uses an external laboratory with accreditation from CPA (UK) Ltd or any other equivalent body.

participates in all EQA schemes available for genetic laboratories. Attachment: Letter from Reprogenetics Director

external laboratory with accreditation from CPA (UK) Ltd or any other equivalent body.

11. Confidentiality and privacy: The centre has not audited how far the confidentiality and privacy procedures comply with the approved protocols, the regulatory requirements and quality indicators (SLC T36).

The PR should ensure that the audit for confidentiality and privacy is completed in the 2013 audit cycle. A copy of the audit findings, and any corrective action should be submitted to the lead inspector by 20 September 2013.

An audit will be completed in the 2013 cycle and will be submitted to the HFEA inspector

The lead inspector is satisfied with the response, to be followed up by September 2013.

12. Disclosure of information held on the HFEA Register, for use in research. A discrepancy was found between 2 completed patient/partner disclosure consents on patient files and consent data submitted by the centre for inclusion on the register. Chair’s letter CH (10)05.

The PR should review procedures for submitting patients’ consent to disclosure to researcher’s decisions to the HFEA. A summary report of the findings of the review including corrective actions and the timescale for implementation of the corrective actions should be submitted to the HFEA by

We have reviewed the current procedure for submitting patients’ consent to disclosure to researcher’s decisions to the HFEA .and corrective actions have been taken including auditing. Attachment: Disclosure of information held on the HFEA Register for use in research document

12 June 2013 The PR has sent revised procedures for submitting patients’ consent to disclosure to researcher’s decisions to the HFEA. Corrective action is planned, which will include the audit of practice in September 2013. No further action required.


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30 June 2013. Three months after the implementation of corrective actions the centre should audit a random sample of ten sets of patient records to ensure that consent to disclosure to researchers taken from patients has been correctly transferred to the HFEA register. The records audited should have had this consent completed within the previous three months. This audit should be submitted to the HFEA for cross reference against the records held by the HFEA.

13. Obligations and reporting requirements of centres (Guidance Note 32) A significant proportion (over 60%) of the licensed treatment data in the audit sample has been submitted to the HFEA outside the period required by Direction 0005.

The PR must ensure that all licenced treatment activity is reported to the Authority within the timeframe required by Direction 0005. The PR should review procedures for meeting the requirements of Directions 0005.

This is again something that we expect will be much better, as we do not have non-Spire satellites.

The lead inspector is satisfied with the response. A copy of the review will be expected by 30 June 2013.


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A summary report of the findings of the review including corrective actions and the timescale for implementation of the corrective actions should be submitted to the HFEA by 30 June 2013.

Additional information from the Person Responsible I would like to reassure the inspection team and the ELP that we have addressed/addressing all recommendations and are taking them very seriously.


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Executive Licensing Panel AgendaItem 1 - Renewal, 00862013-06-05 - Renewal inspection COVER SHEET, Chelsfield Park, Centre 0086 FinalInspection ReportBundle2011 038834 2011-06-24 - ELP Minutes (Item 3) - Interim - Centre 0086

Item 2 - Renewal, 03212013-06-07 cover sheet for ELP centre 03212013-03-12 0321 Renewal Inspection report with PR response2013-02-04 - Renewal application form - centre 0321 - final2013-02-04 - Renewal application Attachments - centre 0321 - final2013-06-05 e-mail from PR 0321 re clarification of licence application2012-05-18 ELP Minutes (Item 3) - Variation of Licence to include embryo biopsy - Centre 03212011 041237 2011-07-28 - LC minutes (item 3) - new licence application - 0321

Item 3 - Renewal, 00082013-05-23 - Cover sheet renewal inspection centre 0008 - final2013-01-30 - renewal application form centre 0008 - final2013-02-27 - report-renewal inspection centre 0008 - final2011 038838 2011-06-24 - ELP Minutes (Item 6) - Interim - Centre 0008

Item 4 - Renewal (0088)2013-03-19 cover sheet for ELP 00882013-05-29 Renewal report centre 0088 - active2013-03-14 TS licence renewal application - 0088 - FinalBundle 00882013-04-12 ELP minutes (Item 4) - Change of LH - Centre 00883096_0013097_001

2011-11-18 ELP Minutes (Item 2) Interim & Variation of Licence Holder Centre 00882010-12-03 ELP Minutes (Item 5) - Variation of licence for change of Licence Holder Centre 0088 and Centre 03082010-07-28 ELP Minutes (Item 6) - Variation change of LH - Centre 0088 & 0308

Item 5 - Interim, 0021 (R0067)2013-05-28 cover sheet interim inspection report, 0021 R0067, for ELP2013-05-10 interim research inspection report R0067 at 0021, May 20132012-09-13 RLC Minutes (Item 6) - Renewal Inspection Report (desk based...2011-09-23 ELP Minutes (Item 5) Interim (R0067) - Centre 00212010-09-10 ELP Minutes (Item 8) - Variation of Premises R0067 (Centre 00...

Item 6 - Interim, 00172013-06-05 - Research - Interim Inspection - ELP Cover Sheet - Newcastle, 00172013-06-05 - Research - Executive Summary - ELP - Request for further information - Newcastle, 00172013-02-28-Centre-0017 R0152 interim research report-Final2013-05-23 ELP minutes (Item 3) - Interim (Research R0152) - Centre 00173569_0013570_001

2011-05-18 - RLC signed minutes - Renewal R0152 - 00172010-05-19 RLC minutes (item 2) - Application to vary research licence (R0152) 0017

Item 7 - Change of PR, 01582013-06-21 Cover sheet for the ELP - change of PR application - 0158 - Final2013-06-21 Executive summary for the ELP - Change of PR application - 0158 - Final2013-05-17 Change of PR application - 0158 - Final2013-05-17 Change of PR application - J Norman-Taylor resignation - 0158 - Final2013-06-21 Change of PR application - P Almeida acceptance letter - 0158 - Final2013-05-17 Change of PR application - P Almeida CV - 0158 - FinalCURRICULUM VITAEPERSONAL DETAILS

Languages: English, Portuguese and Cantonese (Trilingual)EDUCATION AND QUALIFICATIONSPREVIOUS APPOINTMENTSPRESENT APPOINTMENTPRACTICAL SKILLSPROFESSIONAL AFFILIATIONSREGISTRATIONTEACHINGSEMINARS AND PRESENTATIONSMEETINGS AND WORKSHOPS ATTENDEDPUBLICATIONS

Nicopoullos JD, Almeida P, Vourliotis M, Goulding R, Gilling-Smith C. (2010) A decade of sperm washing: clinical correlates of successful insemination outcome. Hum Reprod. 25(8):1869-76.ArticlesAbstracts & Posters Presented at Scientific Meetings

Gilling-Smith C, Frodsham LCG, Tamberlin B, Cox A, Rozis G and Almeida PA (June, 2003) “Reducing reproductive risks in HIV infected couples: a comprehensive programme of care”.ESHRE Annual Meeting, Madrid, Spain.Nicopoullos JD, Gilling-Smith C, Almeida PA and Ramsay JWA (July 2003) “Maternal age: the principal determinant of ICSI success in men with obstructive azoospermia following vasectomy”. Reproduction, Abstract Series 30 : 030: 23.Fertility 2003: Joint Meeting of the society for Reproduction and Fertility, British Fertility Society, and British Andrology Society, Aberdeen, UK.ESHRE Annual Meeting, Madrid, SpainESHRE Annual Meeting, Prague, Czech Republic

Vourliotis M, Nicopoullos JD, Gilling-Smith C and Almeida PA (June 2007). “Pregnancy outcome after Day 3 ET compared to early cleavage Day 2 ET”. Hum Reprod: Supp.1: O019.ESHRE Annual Meeting, Lyon, FranceInternational Society for IVF, Montreal, Canada.

Gilling-Smith, C., Nicopoullos, J.D.M, Cox, A, Almeida, P, Wood, R, Vourliotis, M (July 2008) “Detectable HIV in semen from HIV-1 positive men on HAART with undetectable serum viral load”. O-152.Vourliotis, M., Nicopoullos, J.D.M., Gilling-Smith, C, Almeida, P.A. (October, 2009) “Outcome in Hepatitis B and C infected couples following therapeutic IVF“Tailor S, Vourliotis M, Andronikou S and Almeida P (January 2010) “The effects of using an anti-vibration table on ICSI outcome”BFS Annual Meeting 2010, Bristol, UKPRIZES & AWARDSReferences are available upon request

2013-06-21 Change of PR application - reference 1 - 0158 - Final2013-06-21 Change of PR application - reference 2 - 0158 - Final2011 044424 2011-09-12 - ELP Minutes (Item 1) - Renewal - Centre 01582010 000010315 2010-12-03 ELP Minutes (Item 4) - Interim - Centre 0158

3836_0013837_001

Documents

Inspection Report - Microsoft...Inspection details: The report covers the pre-inspection analysis, the visit and information received from the centre between 26 July 2011 and 24 May