renewal inspection report centre for reproductive medicine

Renewal Inspection Report Trim: 2008/000002614 0013 11 June 2008 of 21

Renewal Inspection Report

Centre for Reproductive Medicine, Coventry 0013

Date of Inspection: 11 June 2008 Date of Licence Committee: 1 September 2008


CENTRE DETAILS Centre Name Centre for Reproductive Medicine, Coventry

Centre Number

0013

Licence Number

L0013/12/a

Centre Address

University Hospitals Coventry & Warwickshire NHS Trust, Clifford Bridge Road Coventry, CV2 2DX

Telephone Number 02476 968879

Type of Inspection

Renewal

Person Responsible

Mr Stephen Keay

Nominal Licensee

Ms Wendy Lane

Inspector(s) Dr Vicki Lamb

Mr Wil Lenton

Mrs Gill Walsh

Mr Stephen Lynch

Fee Paid – up-to-date Not invoiced yet

Licence expiry date

31 December 2008

NHS/Private/Both

Both


Index Page Centre details ......................................................................................................................... 2 Index ....................................................................................................................................... 3 About the Inspection ............................................................................................................. 4 Brief Description, Activities Summary & Risk Assessment............................................... 5 Evaluation & Judgement ....................................................................................................... 6 Breaches, Non-compliance Records, Proposed Licence................................................... 6 Changes/Improvements, Additional Licence Committees ................................................. 7 Organisation......................................................................................................................... 10 Quality of Service ................................................................................................................ 12 Premises and Equipment .................................................................................................... 14 Information ........................................................................................................................... 16 Laboratory and Clinical Practice ........................................................................................ 18 Appendix A........................................................................................................................... 20 Appendix B........................................................................................................................... 20 Appendix C........................................................................................................................... 21


About the Inspection: This inspection visit was carried out on 11 June 2008 and lasted for 8 hours. The report covers the pre-inspection analysis, the visit and information received between November 2007 and June 2008. 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. NB: Where there are very minor issues to be addressed these are noted in the “minor issues to be addressed” section for each topic, and this will facilitate the evaluation of ‘no improvements required’. 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 The Centre for Reproductive Medicine has been licensed since 1992. It provides treatments to NHS and self-funded patients, with commissioning arrangements with Coventry, Solihull, Northampton North and Warwickshire Primary Care Trusts exist. The centre is open seven days a week: - Monday to Friday 7.45am to 6.00pm, Saturday 9.00am to 11.00am and Sundays as required. Egg collections are usually conducted on Monday, Wednesday and Friday with embryo replacements conducted seven days per week as required. The PR, Stephen Keay, was approved as PR by a Licence Committee in July 2008 The laboratory facilities are due to be upgraded in December 2008. The centre has no additional conditions on its licence. Activities of the Centre Licensed treatment cycles 690

Donor Insemination 36 Unlicensed treatments Ovulation induction

Research �� Storage �� Summary for Licence Committee The centre appears well organised and the staff expressed improved satisfaction with their working environment since the last inspection. The inspection team noted that considerable effort had been made to meet the improvements recommended at the last inspection and all but one of these issues had been addressed. A number of regulatory issues were identified in the course of the inspection and these are summarised below:

• Documents are not being reviewed at least every twelve months. • The embryology laboratory door cannot be secured • There have been issues with unauthorised persons gaining access to the archived

records storage area • Validation of equipment and procedures has not been yet been done. • National success rates were not displayed alongside the centre’s success rates.

The executive recommend renewal of the 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 At present documents are not being reviewed at least every twelve months. This is a breach of S.5.2.5.

The inspection team were informed that action has already been taken to address this.

To be reviewed at the next inspection.

The embryology laboratory is not lockable which breaches S.6.3.8 which requires that gametes and embryos are stored in a designated security area with controlled access.

The centre staff confirmed that a lock for this door has been requested.

Lock to be fitted by 31 August 2008.

The room in which archived healthcare records are stored within the Centre is also accessible via an adjoining plant room and there had been issues with workmen gaining access to the record storage room and using it as a short cut. This creates the potential for a breach of confidentiality under section 33 of the HF&E Act.

The PR should assess what further action could be taken to ensure that unauthorised persons cannot gain access to the notes storage area.

By 31 August 2008.

Validation of equipment and procedures is not yet being done. This is a breach of

Validation of equipment and procedures should be undertaken.

By the next inspection.


licence condition A.11.11 and standards S.6.4.2 and S.7.8.3.

Non-Compliance Area for improvement Action required Time scale Success rates for the centre were displayed in the waiting room but no national statistics were given for comparison. This is non-compliance with G.5.3.1(e) in the Code of Practice.

National statistics should be displayed alongside the centre’s own results.

By 31 October 2008

Recommendations Time scale None

Proposed licence variations by last LC None Changes/ improvements since last inspection Recommendations Action Taken The centre had taken 73 days on average to pay HFEA invoices. The HFEA payment terms are 28 days. Payment outside these terms is a breach of standard licence condition A13.3.

The HFEA invoices are now sent to a different person and the last payment was received within 20 days of the date of the invoice.

Processes and equipment within the laboratory had not been subjected to formal validation. Licence condition 11.11 and Code of Practice Standards 7.8.3 and 6.4.2 requires that a programme of validation for equipment and laboratory processes should be introduced.

Validation of equipment and procedures is not yet being done. The centre staff explained that they are waiting for documentation on this to become available from ACE/HFEA.


The PR had not completed the HFEA PR entry programme. Standard 4.1.5 requires that the Person Responsible shall have successfully completed the HFEA's PR assessment process.

The PR and the prospective PR have both completed the PR assessment programme. The executive considered that both documents were satisfactory.

Whilst minutes of senior team meetings were kept and were available on the ‘I’ dive of the Trust computer system, other team meetings were not seen to be routinely recorded. The centre must ensure effective communication to reflect Standard 6.2.13 which requires that centres shall have an effective means of communicating information to staff and receiving suggestions from staff and that records shall be kept of meetings and made available to staff.

Evidence of records of meetings was seen on the inspection. Staff confirmed that they have access to these records.

The results of previously conducted air quality monitoring were not available on the day of inspection; consequently the laboratory air quality could not be verified by the executive. The PR must ensure demonstrable compliance with Licence Condition 10.19 and Guidance G.9.4.3

Evidence that air quality meets the required standard was seen.

The plan for competency assessment of centre staff did not reflect the requirement for existing experienced nursing staff to be able to demonstrate competency in key areas as per Standard Licence Condition 10.9 and Standard S.6.2.9 and Guidance G.1.3.1.

Competency assessments are now being done. This was confirmed by the Quality Manager and evidence was seen on the day of the inspection.

Patient complaints made to the centre were managed in line with Trust Policy; complaints were passed to the Trust Complaints Office. However, this information is shared without seeking prior consent from the complainant to disclose this in accordance with Code of Practice G.6.11.1. It should be noted that the centre provides the HFEA consent to disclosure consent forms to patients. However, it was noted during the audit of patient files that completed consent forms were not explicit that patients consented for their information to be shared with the Trust.

Patients sending in formal written complaints that need to be forwarded to the Trust complaints department are provided with a standard response asking for permission for their complaint to the forwarded to a person not covered by the treatment licence. The Quality Manager confirmed that all staff are aware that letters should not be forwarded to the Trust complaints department without the prior consent of the patient.


The complaints register did not include ‘corrective actions’ taken in response to patient complaints. Code of Practice G.11.3.3 states that ‘a record of the outcome and action taken’ should be included in the complaint’s register.

The complaints log now includes corrective actions.

At the time of a witnessing step often only one of the witnesses signs to state that they have witnessed. Code of Practice Guidance 13.2.1 includes the following statement: A record should be made in the patient/donor notes at the time the procedure takes place confirming: (a) the procedure undertaken; and (b) the date and time of the procedure; and (c) the signature of the person undertaking the procedure; and (d) the signature of the witness to the procedure.

This has been addressed and evidence of this was seen on the day of the inspection.

The centre continues to store active dewars in the embryology laboratory and work to fit a low level oxygen alarm in this busy work area as recommended by licence committee following inspection in both 2005 and 2006 is still outstanding, despite assurance to the Executive that purchases had been made and fitting was awaited.

Oxygen depletion monitors are now in place where liquid nitrogen is used or stored.

As a summary of the last storage audit was not available at the inspection it is recommended that this be submitted to the Executive for review.

Storage audits have been performed since the last inspection and were available for review by the inspection team.

Additional licence conditions and actions taken by centre since last inspection None


Report of Inspection findings 1.Organisation

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

Summary of findings from inspection

Evidence is drawn from:

1. Leadership and management 2. Organisation of the centre 3. Resource management 4. Risk management 5. Incident management 6. Contingency arrangements 7. Business planning 8. Clinical governance 9. Payment of treatment fees

Areas of firm compliance The current PR has submitted a satisfactorily completed PR entry programme and was approved as PR by a Licence Committee in July2008. On the day of the inspection he demonstrated to the inspection team that he was fully conversant with both the functioning of the centre and the requirements of being the PR of a centre. An organisation chart was provided to the inspection team showing clear lines of responsibility. Staffing levels have been increased and changes to working arrangements have been made since the last inspection. In interviews staff expressed improved satisfaction with working conditions. The inspection team were informed that a full training needs analysis is about to be undertaken for the centre staff. All nursing staff mandatory training was seen to have been attended and up to date. Additionally, the staff induction system was seen by the inspectorate. The inspection team were informed that lone working does not occur at the centre any longer. Third party agreements are in place with companies who provide goods/services which may affect the quality and safety of gametes or embryos. Examples of the third party agreements and a log of all third party agreements were supplied to the inspectorate. A contingency arrangement, in case the service cannot be continued, is in place in the form of a reciprocal arrangement with Shrewsbury NHS Trust The incident reporting policy was seen and incidents have been reported to the HFEA appropriately.


The HFEA has not received any complaints about this centre in the last year. Subsequent to the last inspection the average payment time for fees has improved and the last payment was received by the HFEA within 20 days of the date of the invoice. This now meets the requirements of the licence conditions. Areas for improvement None Areas for consideration None Executive recommendations for Licence Committee None Areas not covered on this inspection None Evaluation No improvements required


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

Summary of findings from inspection: 1. Quality Management System 2. Quality Policy 3. Quality Manual 4. Quality objectives and plans 5. Quality Management review/evaluation 6. Monitoring and resolution of complaints 7. Staff suggestions 8. Document control 9. Live Birth Rates

Live Birth Rates Pre-validation and pre-quality assured calculations on the HFEA held register data (31 March 2003-1st April 2006) show: 1

• ICSI/IVF success rates are in line with the national average.

• Frozen embryo transfer success rates are in line with the national average with the exception of age band <35 where they are shown to be significantly lower than the national average.

• Donor insemination success rates are in line with the national average with the

exception of age band >42 which is significantly higher than the national average. Areas of firm compliance A Quality Manager is in post and the Quality Manual was provided to the inspection team and was seen to be comprehensive. The 2008 programme of KPIs and the planned audits for 2008 were seen to be up to date. There is a suggestion box for patients in the waiting room. The comments received are presented on the board in the waiting room along with actions the centre has taken. Also, patient questionnaires are undertaken, analysed and reviewed with corrective actions agreed on. The lead inspector saw the meeting to discuss the patient questionnaires was booked for the day after the inspection. The complaints log now includes corrective action taken as recommended at the last inspection. The previous complaints from patients noted at the last inspection, about calls not being

1 This 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 on our website 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.


returned, have been addressed by having a nurse allocated to answering the phone. Although it was acknowledged by staff that it was not always possible to have a nurse available, the team were informed that someone is available more than half the time. There is also the option for patients to email the centre and staff stated that it was usually possible to reply to emails the same day due to the altered working patterns that have been adopted. A staff questionnaire is done but the Quality Manger reported that the response rate was low and it was therefore difficult to assess levels of satisfaction. Areas for improvement Review dates for documents are set at 12 monthly intervals in compliance with S.5.2.5, but at present the Quality Manager is not able to meet these review intervals. She informed the inspectorate that as a consequence the protocol for reviewing documents has been changed to make the process quicker and enable compliance with this requirement. Areas for consideration None Executive recommendations for Licence Committee At present S.5.2.5 is not being met. The inspection team were informed that action has already been taken to address this and the executive recommend that this is reviewed at the next inspection. Areas not covered on this inspection None Evaluation Some improvement required


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

Summary of findings from inspection:

1. General Suitable premises 2. Clinical facilities 3. Counselling facilities 4. Laboratory facilities 5. Air quality 6. Storage facilities for gametes and embryos 7. Staff facilities 8. Management of equipment and materials 9. Control of records 10. Risk assessments

Areas of firm compliance The inspection team considered that the waiting area provided a calm and pleasant atmosphere. They were informed that patient suggestions had been taken into account when deciding on appropriate signage to use. Swipe card access was seen to be in place to ensure security in critical areas. Patient records are stored behind the reception desk and the door to this room was secured. The cryostore, embryology laboratory and liquid nitrogen store all have low oxygen monitors fitted. These monitors are connected to four alarms, located in the reception, cryostore, laboratory office and the external wall of the liquid nitrogen store. The cryostore was seen to be secure. Evidence was seen that viral positive samples are stored separately from samples from patients who have screened negative. A back-up storage tank is in place in case of failure of one of the other tanks. There is a separate freezing machine for high risk samples and for back-up. Evidence was provided to the inspection team that the air quality meets the required standards. This is tested on a monthly basis at present but will be monitored continuously after the laboratory upgrade scheduled for December 2008. Equipment is serviced and records of this were seen. A small kitchen area is available for staff use and there is a seminar room for meetings. Areas for improvement The embryology laboratory is not lockable which breaches S.6.3.8 which requires that gametes and embryos are stored in a designated security area with controlled access. The centre staff confirmed that a lock for this door has been requested. The inspectorate recommended that this is fitted as soon as possible. The room in which archived healthcare records are stored within the Centre is also accessible via an adjoining plant room. Centre staff informed the inspectorate that there had been issues


with workmen who were servicing the plant room gaining access to the record storage room and using it as a short cut. This creates the potential for a breach of confidentiality under section 33 of the HF&E Act. There is a ceramic breakable bar on the door between the plant room and the record storage room so staff can tell when this room has been entered via that route. The door cannot be locked as it is a fire escape. The PR and Quality Manager informed the lead inspector that no-one has entered the notes storage room via that door for several months, since the problem had been pointed out to managerial staff in the Trust. Areas for consideration The laboratories are due to be upgraded in December. Executive recommendations for Licence Committee A lock should be fitted to the embryology door to ensure compliance with S.6.3.8. The PR should assess what further action could be taken to ensure that unauthorised persons cannot gain access to the notes storage area. Areas not covered on this inspection None Evaluation Some improvement required


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

1. General Information 2. Meetings and communication 3. HFEA Alerts 4. Welfare of child 5. Confidentiality and access to health records 6. Traceability and coding 7. Coding/ identification of samples 8. Information for service users/consents 9. Donor information 10. Donor registration

Areas of firm compliance One couple undergoing treatment were interviewed. They expressed satisfaction with the information they had received and had been given the opportunity to ask questions. They were aware of the counselling facilities and had been able to contact the centre on the telephone without any problems. A large amount of information was available to patients in the waiting room. This included how to contact the centre, opening times, emergency contacts, how to make a complaint and pharmacy charges. The HFEA licence and ISO certificate were also on display. The multidisciplinary team meeting is held weekly. The day of this meeting was moved to enable more staff to attend. Attendance at this meeting is monitored as a KPI and evidence of this was seen. Minutes for the nurse, scientific and patient’s panel meetings were also seen. Welfare of the child documentation was seen to be appropriately completed in patient records. There is a list of staff signatures kept in the Quality Manager’s office and this was seen on the day of the inspection. Evidence was seen that when a protocol is changed staff are required to sign that they have read the new protocol. Traceability records were seen and appeared to record appropriate information to enable traceability of equipment and consumables that may affect gamete and embryo quality. Evidence was obtained that where sperm samples are produced at home the man must sign to confirm that the sample is his and that it has not been tampered with. The centre recruit their own sperm donors which are only used within the centre. The method of ensuring that the 10 family limit is not exceeded was demonstrated to the scientific inspector and appeared to be robust. Centre staff confirmed that sperm donors will now be recompensed in line with Directions D.2006/1, although at present no donors are donating.


Areas for improvement Although results for the centre were displayed in the waiting room there were no national statistics displayed alongside. This is non-compliance with G.5.3.1(e) in the Code of Practice. Areas for consideration None Executive recommendations for Licence Committee The PR should ensure that national statistics are displayed alongside the centre’s own results. Areas not covered on this inspection Surrogacy Evaluation Some improvement required


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

Summary of findings from inspection:

1. Laboratory processes 2. Selection and Validation of laboratory procedures 3. Laboratory’s documented procedures 4. Storage of gametes and embryos 5. Counselling 6. Witnessing

Full time equivalent staff GMC registered doctors 3.1 NMC registered nurses 8 HPC registered scientists 2.8 Scientists working towards registration

3.5

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

4.3

Counsellors 0.75

Summary of laboratory audit / Audit of records Nine sets of patient records were reviewed during the course of the inspection to ensure that consent forms had been appropriately completed. No discrepancies were noted. Seven sets of records were checked to ensure witnessing was being carried out appropriately. No discrepancies were noted. The embryology tanks have been audited this year and it was reported that no discrepancies were found. All 21 sperm tanks have been fully audited this year and 175 discrepancies were identified. The report of the audit was provided to the inspection team. In 150 of these cases the record card was missing and these have all been resolved. In a further 8 cases the consent to the storage of the sperm had expired and these samples have been discarded. In the remaining 17 cases there is a discrepancy between the number of samples recorded as being in the tank and the number of samples that were actually located. The resolution of these discrepancies is ongoing. The centre staff explained that staff changes should ensure that such a high rate of discrepancies should not occur in future. Summary of spot check of stored material Two embryos samples were tracked from tank to records and two from records to tank. No discrepancies were noted. Two sperm samples were tracked from tank to records and two from records to tank. No discrepancies were noted.


Areas of firm compliance The inspection team were informed that new staff have been recruited and the staffing levels are now up to establishment. The normal staffing levels at the centre have also been revised upwards since the last inspection. There have been considerable changes to the staffing and organisational structure, particularly for the nurses, since the last inspection. This has included changes in working hours which appears to have improved morale and created a better working environment for staff and service for patients. The inspectorate considered that there is now more stability in the staffing and leadership at the centre. This was confirmed by the staff that were interviewed and reflected in the patients’ comments. The counsellor stated that she has the facility to refer patients to more specialised therapeutic counselling if required. The counselling hours have been increased to meet demand with a second counsellor being appointed. The newest nurse confirmed that she had had her competencies signed off and she is able to attend courses. She knew what action to take if an incident occurred. She knew where to find minutes of meetings and protocols. The inspection team were informed that the laboratory participates in the NEQAS semen assessment scheme. Evidence of appraisals, CPD and competencies were seen for the laboratory staff. No three embryo transfers have been undertaken since the last inspection. This was confirmed with the centre. Areas for improvement Validation of equipment and procedures is not yet being done. This is a breach of licence condition A.11.11 and standards S.6.4.2 and S.7.8.3. Areas for consideration None Executive recommendations for Licence Committee Validation of equipment and procedures should be carried out. Areas not covered on this inspection

None

Evaluation Some improvement required


Report compiled by: Name……Vicki Lamb………………………………………………………. Designation……Inspector…………………………………………………. Date……14 July 2008……………………………………………………… Appendix A: Centre Staff interviewed The PR and seven members of staff were interviewed.

Appendix B: Licence history for previous 3 years Licence

Status Type

Valid from

Valid to

L0013/12/a Active Treatment with storage

05/07/2007 31/12/2008

L0013/11/a Replaced by new version

Treatment with storage

01/01/2006 31/12/2008



01/09/2005 31/12/2005



01/01/2003 31/12/2005


Appendix C: RESPONSE OF PERSON RESPONSIBLE TO THE INSPECTION REPORT Centre Number0013…………………………………………………………………………………. Name of PR…Stephen KEAY……………………………………………………….……………… Date of Inspection……11th June 2008……………………………………………………..……… Date of Response…29th July 2008……………………………………………………………….… I have read the inspection report and agree to meet the requirements of the report. Signed……by email…………………………………………………………………………..……… Name……Stephen Keay…………………………………………………………………………….. Date……29 July 2008…………………………………………………………………………….… 1. Correction of factual inaccuracies Please let us know of any factual corrections that you believe need to be made (NB we will make any alterations to the report where there are factual inaccuracies. Any other comments about the inspection report will be appended to the report). 2. Please state any actions you have taken or are planning to take following the inspection with time scales Change to document review system with selected members of QMC undertaking document review to improve efficiency. With immediate effect. Sourcing lock for embryology laboratory. To be ordered by September 2008. National Statistics to be displayed in patient areas adjacent to Centres results by October 2008.

Licence Committee Meeting

1 September 2008 21 Bloomsbury Street London WC1B 3HF

MINUTES Item 3 Centre for Reproductive Medicine, Coventry (0013) Licence Renewal Members of the Committee: Walter Merricks, Lay Member – Chair Sally Cheshire, Lay Member David Archard, Lay Member Jennifer Hunt, Senior Infertility Counsellor, IVF Hammersmith

In Attendance: Debra Bloor, Head of Inspection Claudia Lally, Committee Secretary Providing Legal Advice to the Committee: Graham Miles, Morgan Cole

Declarations of Interest: members of the Committee declared that they had no conflicts of interest in relation to this item. The following papers were considered by the Committee:

• papers for Licence Committee (31 pages) • no papers were tabled.

1. The papers for this item were presented by Vicki Lamb, HFEA Inspector. Dr

Lamb informed the Committee that this centre has been licensed since 1992 and provides treatments to NHS and self-funded patients. Dr Lamb reported that the renewal inspection visit took place on 11 June 2008 and noted that considerable effort had been made to meet the improvements recommended at the last inspection and all but one of these issues had been addressed. However, a number of regulatory issues were identified at the visit, as summarised at pages 6 to 7 of the inspection report.

2. Dr Lamb listed the regulatory issues which were identified. These were as

follows. • Documents were not being reviewed every 12 months. • Gametes and embryos were being kept in a laboratory without controlled

access. • Healthcare records were being stored in a room where controlled access

had been breached previously. • Equipment and procedures were not validated.

• Success rates for the centre were displayed in the waiting room without national statistics being provided for comparison.

3. Dr Lamb summarised the response to the inspection’s findings received from

the Person Responsible and appended at page 21 of the report. This response highlighted the follow up action which has been taken by the centre to address the concerns of the inspection team and indicates that all matters have now been addressed other than of the storage room and of validation of equipment and procedures. Dr Lamb explained that the centre is waiting for clarification from ACE and from the HFEA before addressing the issue of validation.

4. Dr Lamb recommended that the centre’s licence be renewed for a period of

five years. The Committee’s Decision 5. The Committee noted the response by the Person Responsible and decided

to renew the centre’s licence for a period of five years. Signed……………………………………. … Date……………….. Walter Merricks (Chair)