renewal inspection report london fertility centre date of ... · sop number: rif-11-a 2009-04-28...

SOP Number: RIF-11-A 2009-04-28 0088 WL T&S Renewal Version: 2 of 23

Renewal Inspection Report

London Fertility Centre 0088

Date of Inspection: 28 April 2009 Date of Licence Committee: 22 July 2009


Centre Details Person Responsible

Dr Magdy Asaad

Nominal Licensee Mr Lawrence Ashford

Centre name London Fertility Centre

Centre number

0088

Centre address

53 Portland Place, London W1B 1QJ

Type of inspection

Renewal

Inspector(s) Wil Lenton (Lead, HFEA Executive) Gill Walsh (HFEA Executive) Steven Lynch (External Inspector) Gladys Dye (HFEA, Observer)

Fee paid Yes

Licence & expiry date

L0088-15-C - 31/08/2009

NHS/ Private/ Both

Private


Index Centre Details .....................................................................................................2

Index ..................................................................................................................3

About the Inspection: ..........................................................................................4

Brief Description of the Centre and Person Responsible ....................................5

Activities of the Centre (HFEA unverified Registry data 01/01/07 to 01/01/08).5

Summary for Licence Committee........................................................................6

Evaluations from the inspection ..........................................................................6

Breaches of the Act, Standard Licence Conditions or Code of Practice: ............7

Non-Compliance .................................................................................................7

Recommendations..............................................................................................7

Additional licence conditions and actions taken by centre since last inspection .9

Report of inspection findings.............................................................................10

1.Organisation.....................................................................................................................10 2. Quality of service.............................................................................................................12 3. Premises and Equipment ................................................................................................14 4. Information ......................................................................................................................16 5. Clinical, laboratory and counselling practice ...................................................................17

Report compiled by: ..........................................................................................19

Appendix A: Centre staff interviewed................................................................19

Appendix B: Licence history for previous 3 years ............................................19

Appendix C: Response of Person Responsible to the inspection report ..........21


About the Inspection: This inspection visit was carried out on 28/04/2009 and lasted for 7 hours. The purpose of the inspection is to ensure that centres are providing a quality service for patients in compliance with the HF&E Act 1990, Code of Practice and to ensure that centres are working towards compliance with the EU Tissue and Cells Directive 2004/23/EC. Inspections are always carried out when a licence is due for renewal although other visits can be made in between. The report summarises the findings of the licence renewal inspection highlighting areas of good practice, as well as areas where further improvement is required to improve patient services and meet regulatory requirements. It is primarily written for the Licence Committee who make the decision about the centre’s licence renewal application. The report is also available to patients and the public following the Licence Committee meeting. At the visit the inspection team assesses the effectiveness of the centre through five topics. These are: How well the centre is organised The quality of the service for patients and donors The premises and equipment Information provided to patients and to the HFEA The clinical and laboratory processes and competence of staff. An evaluation is given at the end of each topic and for the overall effectiveness of the centre: No Improvements Required – given to centres where there are no Code of Practice, legal requirements or conditions that need to be imposed. Some Improvements Required – given to centres that are generally satisfactory but with areas that need attention. Recommendations will usually be made to help Persons Responsible to improve the service. Significant Improvements Required – given to centres that have considerable scope for improvement and have unacceptable outcomes in at least one area, causing concern sufficient to necessitate an immediate action plan or conditions put on the Licence. Where recommendations are made the HFEA will provide details of what needs to be addressed but not how they should be carried out as this is the responsibility of the Person Responsible. The report includes a response form for the Person Responsible to complete following the inspection. The HFEA welcomes comments from patients and donors, past and present, on the quality of the service received. A questionnaire for patients can be found on the HFEA website www.hfea.gov.uk .


Brief Description of the Centre and Person Responsible In September 2008, the centre acquired new licensed premises at 53 Portland Place, London W1B 1QJ, which are situated a short 2-5 minute walk from the former premises. The centre title (London Fertility Centre – LFC) and centre number (0088) were transferred to the newly-licensed premises, from the previous centre at Cozen’s House, 112A Harley Street, London W1G 7JH, which then became centre 0308, London Fertility Centre (storage) The new premises were licensed on 15 September 2008 and are predominantly for delivery of licensed activities, such as;

• Gamete procurement (Oocyte retrievals/ sperm production) • Patient recovery • Processing of gametes/embryos • Inseminations • Embryo transfer • Storage of gametes/embryos

and as such have been refurbished to a high standard to ensure patient confidentiality and dignity and to comply with European Union Tissues and Cells Directives (EUTD). The centre is open seven days a week but oocyte retrievals are not routinely scheduled for weekends. The centre has links to fifteen satellite centres. The Person Responsible (PR) Dr Magdy Asaad is appropriately qualified, and has successfully completed the Person Responsible Entry Programme (PREP).

Activities of the Centre1 (HFEA unverified Registry data 01/01/07 to 01/01/08) In vitro fertilisation (IVF) 511 Intracytoplasmic sperm injection (ICSI) 472 Frozen embryo transfer (FET) 127 Egg donor/recipient 33 Donor Insemination 23

Research Yes Storage gametes/embryos Yes

1This data is supplied to the HFEA by individual clinics who are responsible for its accuracy and for verifying it.

The data published by the HFEA is a snapshot of the state of the Register at a particular time. 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.


Summary for Licence Committee The Person Responsible (PR), Dr Magdy Asaad is appropriately qualified and has successfully completed the Person Responsible Entry Programme (PREP). The centre moved to new premises, which have been refurbished to a high standard to ensure patient confidentiality and dignity and to comply with the European Union Tissues & Cells Directives (EUTD). The new premises were licensed by the HFEA on 15 September 2008. The relocation to new premises has addressed many of the regulatory issues reported in the previous report. The centre was found to be well organised, with an experienced senior management team in charge of service delivery. There appeared to be adequate numbers of qualified and trained staff in post to deliver the services provided. During the course of the visit a number of regulatory issues were identified and are summarised in the tables below. It is recommended that the PR provides information on the measures and steps to be taken to address all breaches highlighted in this report. The Executive supports the renewal of the centre’s licence for a period of five years.

Evaluations from the inspection Topic No

Improvements required

Some Improvement required

Significant Improvement required

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


Breaches of the Act, Standard Licence Conditions or Code of Practice: The table below sets out matters which the Inspection Team considers may constitute breaches of the Act, Standard Licence Conditions and/or the Code of Practice, and their recommended improvement actions and timescales. The weight to be attached to any breach of the Act, Standard Licence Conditions or Code of Practice is a matter for the Licence Committee;- Breach Action required Time scale There has been no documented validation of laboratory procedures which is required to ensure the safety and quality of patient gametes and embryos. (CoP S.7.8.3)

Validation of laboratory procedures should be undertaken to ensure the safety and quality of gametes and embryos

To be completed by 31/12/2009

Non-Compliance Area for improvement Action required Time scale N/A

Recommendations Area for improvement Action required Time scale It was noticed that the centre displayed ‘success rate’ & ‘clinical pregnancy rate’ data for the years 2007 and 2008 instead of the more accurate ‘live birth rate’ data on their website. The centre should ensure that any data made available to the general public is accurate. CoP7; A.10.28

The centre should ensure that accurate information relating to live birth rates are made available via the centre’s website.

With immediate effect


Changes/ improvements since last inspection Recommendations Action Taken Annual appraisals are not presently performed/recorded for laboratory staff. S.6.2.10

Annual appraisals for all Centre staff, including laboratory staff, are in the process of being undertaken for 2009. We expect that all appraisals will be completed by the time of the inspection.

A staff competency framework is in place but requires evidence of periodic evaluation. S.6.2.9

The clinical department heads are evaluating staff competency as part of the appraisal process.

There is presently no documented procedure for the induction of new laboratory staff. S.6.2.7

There is an approved SOP for the induction of new laboratory staff.

Not all SOP’s have been reviewed within the last twelve months. S.5.2.5(a)

The Centre’s policy on SOP revision has been revised to show that all SOP’s must be reviewed annually.

Improvements to the present premises are required in order to improve the privacy and dignity of patients when undergoing egg collection and recovery. S.6.3.2/ S.6.3.3/S.6.3.4(a)ii

This issue has been addressed by the transfer to the new centre premises.

The nurses room/recovery area needs to be separated in order to address confidentiality issues which arise when it is jointly used. S.6.3.2/S.6.3.3/S.6.3.4(a)ii


The air-quality monitoring documentation observed on the day requires more information from the external company performing the assessment, on both how the tests were performed and how the results are interpreted. S.6.3.6/S.7.8.5

This issue has been addressed by the transfer to the new centre premises. Constant monitoring of air within critical areas such as the laboratory and theatre are provided via the Facilities Monitoring System (FMS).

There was a lack of security observed between the scan room and patient records room on the day of inspection. S.7.2.1



A full audit of cryostored material is presently taking place every three years instead of two as required. S.7.8.12(b)

A full audit of cryopreserved material is now taking place every year. An audit is ongoing and the most recent audit reports have been provided

The practice of recording witnessing steps needs to be both better illustrated within the current standard operating procedure (SOP) and recorded on the laboratory worksheet. (to state ‘which event’ is being witnessed at each step.) S.7.8.15

A review of recorded witnessing steps has been undertaken and laboratory worksheets and forms have been revised to reflect current practice. The revised documents were submitted to the HFEA on 10 September 2008.

The laboratory does not currently participate in any inter-laboratory audits such as the UKNEQAS scheme. S.4.2.9(e)/ S.9.2.6

The laboratory does participate in UKNEQAS scheme and has recently undertaken the UKNEQAS Andrology assessment.

A traceability log of consumables used within the laboratory and which come into contact with gametes/embryos is not presently in place. S.7.3.1(d)

A traceability log of consumables used within the laboratory is now in place on the patient’s electronic record on the Centre’s IDEAS database.

Key Performance Indicator (KPI) measurements need to be formalised. S.4.2.9(f)

The monitoring of KPI’s has been formalised.

Information sheets observed within the waiting room relating to cumulative success rates for egg-donation were found to be non-verified and misleading. S.7.4.1

The information sheet with cumulative success rates for egg donation was revised immediately following the inspection and was provided to the inspectorate.

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


Report of inspection findings

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

Summary of the findings from the inspection of the following areas of practice: • Leadership and management • Organisation of the centre • Resource management • Clinical governance • Risk management • Incident management • Alert management • Complaints management • Contingency arrangements • Establishment of third party agreements • Meetings / dissemination of information • Payment of licence/treatment fees

Areas of firm compliance The Person Responsible (PR) Dr Magdy Asaad is appropriately qualified, and has successfully completed the Person Responsible Entry Programme (PREP). He is supported in this role by an experienced senior management team, which includes a quality manager. The quality manager overseas the maintenance and development of the quality management system (QMS) which underpins the activities within the centre. An organisational chart describing the management structure and reporting responsibilities within the centre was made available via the QMS. A detailed staff list provided evidence that the centre had adequate numbers of qualified/trained staff with which to deliver the range of patient services provided. Documented protocols and procedures were readily available and showed evidence of annual review. It appeared that the organisational structure and operational procedures were appropriate for the licensed activities undertaken at the centre. Regular minuted meetings occur. The minutes from recent general management and quality management meetings were reviewed on the day of inspection. HFEA Alerts are discussed at department heads meetings and then disseminated to staff and made available via the centre’s electronic database. The centre has a formal clinical governance framework, which monitors patients complaints, reviews incidents and monitors patient satisfaction surveys. The complaints and incident logs were reviewed on the day of inspection and found to be compliant with CoP7 requirements as per S.9.2.2 & S.9.4.2 respectively. There is a Health and Safety committee which meets quarterly to review all issues related to risk management and patient/staff health and safety before feeding back to department heads.


Information received from the finance department indicates that invoices are currently being paid on time, on average within 24 days of receipt. The centre has a formal contingency arrangements is in place with CRM London (0199). Areas for improvement None. Areas for consideration None. Executive recommendations for Licence Committee None. Evaluation No improvements required. Areas not covered on this inspection None.


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

Summary of the findings from the inspection of the following areas of practice: • Quality management system • Quality policy • Quality manual • Quality objectives and plans • Quality management review/evaluation • Feedback • Document control • Live birth rates

Live birth rates1 Registry data for the most recent three year period for which a full and confirmed data set is available for all centres (2004 – 2007), indicates that live birth rates for IVF/ICSI and donor insemination at the centre are comparable with national averages1. Areas of firm compliance There is a designated quality manager in post and a quality management system (QMS) in place which is pass-word protected and accessible to all staff via the centres database system. Only the quality manager can amend active documents such as SOP’s within then QMS, which are reviewed on an annual basis or as required, such as if there has been a change to professional practice. The quality manager gave the inspection team access to the electronic QMS and illustrated different files covering topics such as, HFEA Alerts, minuted meetings, standard operating procedures and patient survey analysis. There are documented procedures in place for staff to take into account Welfare of the child (WoC) issues. Any such issues arising are discussed internally with senior management. The centre has a designated complaints officer in post together with a documented complaints procedure which is highlighted within the patient waiting area. Areas for improvement None. Areas for consideration None. Executive recommendations for Licence Committee


None. Evaluation No improvements required. Areas not covered on this inspection None.


3. Premises and Equipment Desired outcome: The premises and equipment are safe, secure and suitable for their purpose. Summary of the findings from the inspection of the following areas of practice: • Premises • Clinical facilities • Counselling facilities • Laboratory facilities • Air quality • Management of equipment and materials • Storage facilities for gametes and embryos • Staff facilities • Storage of records

Areas of firm compliance The centre moved into newly-licensed, purpose built premises during September 2008. A licence was issued by the Authority in respect of the new facilities on 15 September 2008. The new premises are situated over two floors and provide all facilities required to deliver the range of licensed treatments specified on the centres licence. All clinical and laboratory facilities were observed on the day and found to be fit for purpose by the inspection team. The new premises were found to be secured via either swipe-card access restricted to certain groups of staff or by digilock access which required a code. A HEPA filtered positive pressure ventilation system is utilised in the theatre and laboratory areas. The air management system provides air quality which is constantly monitored and compliant with the requirements of the EUTD. A log of air quality was made available to the scientific inspector and found to be compliant with S.6.3.6(b); S.7.8.5(a)(b). The embryology and andrology laboratories incorporate a ‘facilities monitoring system’ (FMS) which monitors all critical use equipment, such as incubators, cryostorage vessels and refrigerators. The laboratory manager regularly monitors the FMS system, which is configured to alarm if any parameters vary from pre-determined set values. A policy was seen to be in place, describing the procedure of how to respond to out-of-hours alarms. Cryo-dewars at the centre were seen to be secure and fitted with low liquid nitrogen alarms connected to the FMS and an auto-dialler system for out-of-hours alerts. A low Oxygen monitor was in place within the cryostorage area, with an external audio/visual alarm linked to the reception area. All critical use equipment is either under manufacturer’s warranty or on service/maintenance contract, which were reviewed and found to be up-to-date by the inspection team. A back-up generator was seen to be in place and which would be used in the event of power


loss to the premises. Only patient records required for on-going treatment cycles are stored securely on site. Areas for improvement None. Areas for consideration None. Executive recommendations for Licence Committee None. Evaluation No improvements required. Areas not covered on this inspection None.


4. Information Desired outcome: Information is relevant, clear and up to date for patients and the HFEA Summary of the findings from the inspection of the following areas of practice: • Information for service users • Consent • Welfare of the child • Access to health records • Provision of information to the HFEA register

Areas of firm compliance Comprehensive and accurate written patient information was reviewed via the electronic QMS. Patients are given both written and oral information by appropriately trained staff and there are contact numbers within the supplied documentation, so that patients can contact centre staff if they have any outstanding issues. Consents are taken by trained staff following dissemination of patient information and after an appropriate time has elapsed in order that patients are aware of all issues concerned. Documented procedures were seen to be in place to ensure that welfare of the child issues are appropriately addressed by centre staff. Evidence was available in patient records reviewed on the day of inspection and gleaned via discussions with centre staff. A senior nurse had recently delivered a presentation to satellite centre staff concerning the introduction of the new ‘Legal Parenthood Provision’. The Registry department at the HFEA report that there are no problems with the provision of information from the centre. Areas for improvement It was noticed that the centre displayed ‘success rate’ & ‘clinical pregnancy rate’ data for the years 2007 and 2008 instead of the more accurate ‘live birth rate’ data on their website. The centre should ensure that any data made available to the general public is accurate. (CoP A.10.28) Areas for consideration None. Executive recommendations for Licence Committee The centre should ensure that accurate information relating to live birth rates are made available via the centre’s website. (CoP A.10.28) Evaluation Some improvements required. Areas not covered on this inspection None.


5. Clinical, laboratory and counselling practice Desired outcome: Clinical, counselling and laboratory practices are suitable and are provided by competent staff.

Summary of findings from inspection:

• Staff training and competency • Clinical practice

o Screening of donors o Three embryo transfer

• Laboratory practice o Procurement, distribution and receipt of gametes and embryos o Traceability and coding o Selection and validation of laboratory procedures o Coding/ identification of samples o Witnessing

• Counselling practice o Counselling audit

• Storage of gametes and embryos

Full time equivalent staff GMC registered doctors 4 NMC registered nurses 4 Non NMC registered clinical staff 3 HPC registered scientists 2 Scientists working towards registration 3 Support staff (receptionists, record managers, quality and risk managers etc) 18.6 Counsellors 0.6

Summary of laboratory audit The majority of cryopreserved patient samples (gametes & embryos ) are presently stored at the former premises, which is now centre 0308. As this is the main storage centre the recently submitted audit is being assessed as part of centre 0308 management practices and not 0088. Summary of spot check of stored material Two cryopreserved sperm and embryo sample was tracked from database to cryotank and vice versa. No discrepancies were found. Areas of firm compliance In discussion with the laboratory manager it was stated that;

• ongoing competency assessments were being performed by a senior embryologist. Evidence to this effect was seen by the scientific inspector.

• annual appraisals are now taking place for laboratory staff and documents held within

individual human resources records.


• an SOP was in place for induction of new laboratory staff and trainees are encouraged

to attain the Association of Clinical Embryologists (ACE) certificate. Evidence for clinical staff induction was observed in the staff training log of the most recently employed nurse. Ongoing training is documented appropriately with ten days of ‘continuing professional development’ (CPD) available to all staff, as was evidenced within the training log of the senior nurse. Laboratory witnessing documentation and procedures were reviewed by the scientific inspector and found to be compliant. Evidence seen on the day of the inspection showed that the laboratory was now participating in the UKNEQAS. An electronic traceability spreadsheet was reviewed on the IDEAS database system and found to be compliant. Evidence was seen for the validation of new laboratory equipment (supplied by the manufacturer). Counselling facilities and services were found to be appropriate for the treatment services provided. Counselling records were seen to be stored securely in the associated Logan building. A counselling audit was submitted with the pre-inspection documentation and found to be satisfactory. Areas for improvement There has been no documented validation of laboratory procedures which is required to ensure the safety and quality of patient gametes and embryos. Areas for consideration Laboratory KPI were observed as being recorded, but it was discussed as to how they might be best utilised eg compare to retrospective data or published data. The majority of laboratory consumables are CE marked but a small minority of products remain non-CE marked. Executive recommendations for Licence Committee Validation of laboratory procedures should be undertaken to ensure the safety and quality of patient gametes and embryos (CoP S.7.8.3) Evaluation Some improvements required. Areas not covered on this inspection None.


Report compiled by: Name……………Wil Lenton…………………………. Designation…….Inspector………………………........ Date……………..28 April 2009……………………….

Appendix A: Centre staff interviewed The PR plus; Quality manager Senior nurse manager Laboratory quality manager Senior embryologist Counsellor

Appendix B: Licence history for previous 3 years 28 May 2009: Variation of PGS licence to include new methodologies 11 September 2008: Licensing of new premises at 53 Portland Place with transfer of title and centre number 12 May 2008: - Variation of licence to include PGD for ‘Chromosomal Rearrangements’ on licence. 1 May 2008: - Export of patient sperm/embryos under Special Directions 19 March 2008: Additional visit following incident and acceptance of Dr Asaad as new PR 28 January 2008: - Prof Craft to continue in temporary role whilst Dr Asaad (proposed new PR) completes PREP 17 December 2007: Departure of Mr Hodgson (PR) – Prof Craft to continue in temporary role. 28 November 2007: Notification of change of PR – Special Directions for Prof Craft to assume temporary role. 3 September 2007: Consideration of interim inspection report 23 May 2007 Change of PR The Committee agreed to vary the centre’s licence to add Mr Hodgson as the new Person Responsible.


26th April 2007 Variation of Licence under the EUTD Legislation The Licence Committee agreed to vary the licence to incorporate the requirements of the EUTD.


Appendix C: Response of Person Responsible to the inspection report Centre Number…………………………0088…………………… Name of PR………………………Dr Magdy Asaad………… Date of Inspection…………………28 April 2009…………….. Date of Response…………………12 June 2009……………… I have read the inspection report and agree to meet the requirements of the report. Signed…………………………………………………………………………………………………… Name…………………………… Dr Magdy Asaad ………………………. Date……………………………...12 June 2009…………………………… 1. Correction of factual inaccuracies Please let us know of any factual corrections that you believe need to be made. We will make alterations to the report where there are factual inaccuracies. 2. Please use the space below to document any comments or additional information that you would like to be considered by a Licence Committee. London Fertility Centre is pleased that the HFEA Executive have reflected the hard work and investment made by the Centre over the past year, particularly with regards to the new premises at 53 Portland Place, in this report and have recommended a five year licence be granted. 3. Please state any actions you have taken or are planning to take following the inspection with time scales On 12 May 2009, LFC updated the success rates page of the website providing a link to the HFEA find a clinic live birth rate page for LFC to provide patients with access to the latest published live birth rate data. ��

�

The inspectors commented that LFC’s website displayed a disclaimer which in essence removed the responsibility of the accuracy of information displayed on the website from LFC. The disclaimer has now been revised and is published on our website in the revised form. ��


�

The inspectors suggested that the website have more details regarding 53 Portland Place for patients. A new page has been created and a description of services for each of LFC’s premises is available on the website. �� The current competency assessment form for laboratory staff will be expanded to ensure that the relevant protocol is conducted correctly at the same time as assessing the member of the lab. The validation of the protocol will thus rely on the current assessment as well as historic data and experience gained from conducting that procedure. Where relevant, the scientific references will be included in the protocols where it has been left out before.


We welcome comments about the inspection on the inspection feedback form, a copy of which should have been provided at the inspection. If you require a copy of the feedback form, please let us know. Please return Appendix C of the report electronically to your inspector or in hard copy to: Regulation Department Human Fertilisation & Embryology Authority 21 Bloomsbury Street London WC1B 3HF

renewal inspection report london fertility centre date of ... · sop number: rif-11-a 2009-04-28...

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