interim inspection report glasgow nuffield hospital acs 0115

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Interim Inspection Report

Glasgow Nuffield Hospital ACS 0115

Date of Inspection: 31st May 2007 Date of Licence Committee: 3rd September 2007

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CENTRE DETAILS Centre Address Glasgow Nuffield Hospital ACS

Beaconsfield Road Glasgow G12 0PJ

Telephone Number 0141-334-9441

Type of Inspection

Interim Inspection

Person Responsible

Mr Robin Yates

Nominal Licensee

None

Licence Number

L0115-11-b

Inspector(s) Tony Knox Sarah Hopper Grace Cunningham

Fee Paid - date Not Due

Licence expiry date

31st December 2008

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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 ................................................. 9 Organisation......................................................................................................................... 10 Quality of Service ................................................................................................................ 12 Premises and Equipment .................................................................................................... 14 Information ........................................................................................................................... 16 Laboratory and Clinical Practice ........................................................................................ 18 Appendix A........................................................................................................................... 20 Appendix B........................................................................................................................... 21 Appendix C........................................................................................................................... 22

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About the Inspection: This inspection visit was carried out on 31st May 2007 and lasted for 6 hours. The report covers the pre-inspection analysis, the visit and information received between September 2005 and June 2007. The purpose of the inspection is to ensure that centres are providing a quality service for patients in compliance with the HF&E Act 1990, Code of Practice and to ensure that centres are working towards compliance with the EU Tissue and Cells Directive 2004/23/EC. Inspections are always carried out when a licence is due for renewal although other visits can be made in between. The report summarises the findings of the interim inspection highlighting areas of good practice, as well as areas where further improvement is required to improve patient services and meet regulatory requirements. It is primarily written for the Licence Committee who make the decision about the centre’s licence renewal application. The report is also available to patients and the public following the Licence Committee meeting. At the visit the inspection team assesses the effectiveness of the centre through five topics. These are: How well the centre is organised The quality of the service for patients and donors The premises and equipment Information provided to patients and to the HFEA The clinical and laboratory processes and competence of staff. An evaluation is given at the end of each topic and for the overall effectiveness of the centre: No Improvements Required – given to centres where there are no Code of Practice, legal requirements, recommendations or conditions that need to be imposed. Some Improvements Required – given to centres that are generally satisfactory but with areas that need attention. Recommendations will usually be made to help Persons Responsible to improve the service. Significant Improvements Required – given to centres that have considerable scope for improvement and have unacceptable outcomes in at least one area, causing concern sufficient to necessitate an immediate action plan or conditions put on the Licence. The report includes a response form for the Person Responsible to complete following the inspection. The HFEA welcomes comments from patients and donors, past and present, on the quality of the service received. A questionnaire for patients can be found on the HFEA website www.hfea.gov.uk .

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Brief Description of the Centre and Person Responsible The Centre is well established and has been providing licensed treatments to privately funded patients since 1992. The last inspection of the centre was in August 2005. It has a good history of regulatory compliance. The PR stated that patients using the services at the Nuffield Hospital are mainly either in the age range where they would not receive NHS funding or have completed their funded treatments elsewhere. On 14th May 2007, an application to vary the centres licence in preparation for the EU Tissue and Cells Directive requirements, was put before a Licence Committee showing a risk score of 2%, and the variation to licence was approved. The centre has recently commenced the recruitment of sperm donors, and has already achieved some success with their first cleared donors. The PR also acts as the PR at the Glasgow Royal Infirmary ACS. Time is allocated between the two centres as per the requirements of the patients undergoing treatment. The inspectorate found that this did not have a detrimental impact on the services provided at either the Glasgow Royal Infirmary or at the Glasgow Nuffield Hospitals. Activities of the Centre Data provided below is taken from HFEA data for the period 1/1/06 – 31/12/06

Licensed treatment cycles

Egg Donor IVF ICSI FET

2 183 195 136

Donor Insemination 50

Unlicensed treatments

IUI OI

Research No Storage Yes Summary for Licence Committee The centre appears well organised and many improvements have been made since the last inspection. The executive recommend the continuance of the centres licence with no additional conditions. Risk Assessment Following the last inspection in August 2005, a risk score of 5% had been generated for the centre. Following this inspection, the risk score was re-calculated at 11%. This higher risk rating primarily relates to the additional work required within the laboratory and treatment rooms to bring air quality to within the requirements of the EU Tissue and Cells Directive. The centre follows both risk management and clinical governance procedures and protocols of the Nuffield Hospitals Group.

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Overall judgement of the effectiveness of the centre No Improvements required Some Improvement

required Significant Improvement required

X 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 or Code of Practice Breach Action required Time scale None

Non-Compliance Area for improvement Action required Time scale It was established both by observation and interview that all witnessing procedures are carried out contemporaneously and in accordance with HFEA guidance however, the protocol for witnessing did not capture all steps performed. It was noted by the scientific inspector that witnessing of samples going into the tanks after processing is not currently witnessed, and that the centre are not documenting the discard of embryos.

Witnessing protocol to be updated to reflect current practice. Samples must be witnessed being placed into the tanks and the discarding of embryos must be documented.

Immediate. Immediate.

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Recommendations Time scale Although key senior members of staff were aware of all HFEA alerts issued, (HFEA alert folder evidenced at inspection), not all staff were aware of the alerts issued. Recommendation was made to circulate all HFEA alerts to all staff.

Immediate.

There is only one independent counsellor working within the unit. Recommendation was made to investigate alternative counselling cover for sickness and holiday relief etc.

Three months.

Although there are two low oxygen monitors within the laboratory area, there was no monitor inside the cryostore. Recommendation was made to re-position one low oxygen monitor to inside the cryostore.

Immediate.

One set of patient notes contained both the centres copy and the patients’ copy of HFEA consent form 006. Patient copy of HFEA consent form 006 to be posted to the patient.

Immediate.

Female patients who consent to allow their partners to use their embryos posthumously are not currently screened or progressed as donors. Female patients who sign posthumous consent to use of embryos in the event of their death or mental incapacity to be processed as donors and screened accordingly.

Immediate.

The centre has no formally documented contingency service level agreement, although there is a “letter of Intent” in place with the Glasgow Royal Infirmary ACS. A formal contingency service level agreement to be documented for cases of emergency.

Six months.

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Nursing and embryology staff (14 in total), are required to share one office within the unit. This was noted by the inspectorate to be inadequate for the number of staff employed to use this space and for the activities which have to be conducted within the area. Recommendation was made to address this issue to reduce stress levels and to conform to Health Safety and Welfare Regulations.

Six months.

Recommendation was made to source an appropriate quality management training course for the Quality Manager to assist her with complying with her responsibilities.

Six months.

Recommendation was made to ensure that air quality within the laboratory and treatment areas meets with the requirements of the EU Tissue and Cells Directive.

End of December 2007

Proposed licence variations None

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Changes/ improvements since last inspection Recommendation Action taken No dedicated sperm production room.

There are two rooms on the ACS Unit which are used for patients pre and post operative care. Each room has its own en-suite bathroom. These bathrooms are used as producing rooms as and when required. This was not considered to be a problem either by the patients interviewed or by the inspectorate.

No clinical or counselling protocols.

These were evidenced within the quality manual and are version controlled.

Two dewars were not alarmed and no autodial facility was in place.

All dewars are alarmed (with the exception of the emergency dewar) and linked to an autodial facility.

Patient information provided pre-August 2005 inspection was considered to be out of date.

Patient information reviewed for this inspection contained appropriate information and was up to date.

Location of the low oxygen alarms within the laboratory was considered to be inappropriately situated.

See recommendations above.

No discreet nursing policies. All nursing policies and procedures were evidenced within the quality manual and were appropriately version controlled.

Dewars were not clearly marked to show their content.

All dewars were marked clearly to show their content.

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

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Report of Inspection findings 1. Organisation

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

Summary of findings from inspection Evidence is drawn from: � Leadership and management � Organisation of the centre � Resource management � Risk management � Incident management � Contingency arrangements � Business planning � Clinical governance � Payment of treatment fees

Areas of firm compliance • The centre appeared well organised and all staff interviewed said that they felt supported

by the management. • The PR shares his time with the Glasgow Royal Infirmary ACSU at which he also holds

the post as PR. The PR stated that work schedules have been devised to ensure that this causes no detrimental affect on the patients receiving treatment at either centre. Staff interviewed confirmed this.

• Nursing, laboratory and clinical staff were seen to be employed in sufficient numbers for the number of treatment cycles performed at the centre.

• The centre has a robust incident policy which meets with the requirements for reporting to the HFEA. All staff interviewed were aware of the incident policy and the procedure to follow should an incident occur.

• The PR has presented a plan for the upgrade of the air quality within the laboratory and treatment areas to meet with the requirements of the EU Tissue and Cells Directive. The PR stated that the Nuffield Hospital senior management were supporting of the fertility unit and approval of funds had been made available for the required alterations to upgrade the air quality management system. This work has been arranged during the November shut down to minimise disruption to patient care on the fertility unit as well as to the rest of the Nuffield Hospital activities.

• The centre follows the Nuffield Hospital groups risk management and clinical governance policies and procedures. Regular meetings are held for Clinical Risk Management which are minuted and were evidenced during the course of the inspection. A Quality Manager has been appointed, and the centre has a robust quality manual in place containing all of the centre policies and procedures which were evidenced as being version controlled. Quality Management meetings are held monthly. Minutes are taken at the meetings and were evidenced during the inspection.

• A risk assessment folder was presented for review during the inspection containing 21 risk assessments including risk of fire and the use of laser for assisted hatching processes. In addition, a full set of Control of Substances Hazardous to Health (COSHH) assessments were also provided.

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• During the course of the inspection, a fire emergency evacuation was conducted. All staff and patients were evacuated in accordance with the Nuffield Hospitals policies and procedures quickly and effectively.

• The Finance Department at the HFEA report no problems associated with payment of invoices.

Areas for improvement • Administration staff interviewed stated that they would benefit from having additional

assistance to aid with sickness cover and annual leave. It was also noted that additional assistance in administration would also ensure that reporting of treatments through the HFEA EDI system could be improved upon. The PR noted that staffing levels within the administration department were to be increased within the near future.

• At present, there is no formal service level agreement (SLA) in place for contingency arrangements in the event of the unit having to be closed unexpectedly. The PR noted that a “Letter of Intent” was in place with the Glasgow Royal Infirmary ACSU covering contingencies however. It was recommended that this be formalised.

• Although key personnel interviewed were aware of the last published HFEA alert, some staff interviewed were unsure of when the last alert had been issued. The PR noted that alerts are circulated to key personnel and then filed in a HFEA alerts folder (evidenced during the inspection). It was recommended that alerts should be circulated to all staff which was agreed by the PR.

Executive recommendations for Licence Committee None Areas not covered on this inspection All areas covered. Evaluation Some improvement required.

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

Summary of findings from inspection: � Live birth rates � ‘Welfare of the Child’ arrangements � Confidentiality (including safe storage of patients’ records) � Choice of treatments � Privacy and dignity of patients � Complaint handling � Patient feedback and satisfaction � Counselling facilities and services � Donor selection � Egg sharing and surrogacy � Protection of children arrangements (for patients under 18yrs)

Live Birth Rates Data obtained from the HFEA statistics (31st March 2002 – 1st April 2005) shows IVF and ICSI rates for all age ranges to be above national averages. Statistics for frozen embryo transfer (FET) in age ranges below 35 through to 39 also were above the national average whilst the figures for FET in age range 40 – 42 were significantly above the national average. Areas of firm compliance • All notes reviewed during the course of the inspection provided evidence that a suitable

“Welfare of the Child” assessment had been conducted. Patients interviewed stated that they had been made aware of the requirement for this assessment to be carried out. The PR explained that any potentially contentious treatments would be discussed primarily within the team to determine whether a consensus for providing treatment could be established. If this was not possible, cases can be forwarded onto the centres ethics committee. Ethics committee meetings are minuted and evidence of these minutes were seen during the inspection.

• Patients and donors are given full information both in consultation and by means of patient information booklets regarding the treatment options available to them. All patients interviewed stated that they had been properly informed of the treatment options open to them and felt included in the decision making process.

• All patients interviewed stated that they were satisfied with the level of care that they had received at the centre and had confidence in the staff. This was reiterated both in the responses received from the HFEA patient questionnaire (17 responses received) and also in the centre’s own patient questionnaire survey.

• The centre has a robust complaints policy which meets with the requirements of the HFEA. All staff interviewed were aware of the processes which had to be followed upon receipt of a complaint.

• Counselling is provided to patients free of charge. Counselling protocols are in place and were evidenced during the inspection. Two counsellors were interviewed: - MC (who is retiring soon) and ME (who had previously provided cover for MC during sickness and annual leave) and will replace her. Both counsellors have been working at the unit since

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March 2007. Since March, MC has only seen patients returning to the centre for continued counselling sessions whilst ME has taken all new cases. Both counsellors are appropriately qualified and receive regular supervision. MC is registered with BICA and ME is registered with BACP. Both counsellors stated that their counselling notes kept securely at their own homes, accessible only to themselves. It was noted that counselling notes will not be passed on from one to the other as each believed it important to build their own rapport with patients and not to be influenced by another counsellors comments/notes.

• A counselling audit provided for the period January 2006 through to April 2007 was provided showing a total of 188 counselling sessions conducted.

• Counselling is provided free of charge to patients and is easily accessible. • The centre has recently commenced its own sperm donor bank. Protocols were

evidenced and found to be fit for purpose by the inspectorate. All screening is performed as per requirements.

Areas for improvement • It was noted that once the primary counsellor has retired, her replacement will have no

cover for sickness or annual leave. It was recommended that consideration should be given to sourcing a backup to ensure the continuity of this service if such an event occurred.

Executive recommendations for Licence Committee None Areas not covered on this inspection Egg sharing and surrogacy. Protection of children arrangements. Evaluation Some improvement required.

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

Summary of findings from inspection:

� Suitable premises � Storage facilities for embryos and gametes � Safe equipment, servicing and maintenance � Prevention of incidents/ accidents

Areas of firm compliance • All areas of the clinic were seen to be clean and well maintained. • The unit consists of a reception area, nursing and embryology office (see below),

treatment room, two patient rooms (used for pre and post operative recovery) with two additional rooms made available on the ward above the unit if required, scan room and changing room, cryostore inside the embryology laboratory and an operating theatre. Men who are required to produce a sample are directed into one of the en-suite bathrooms linked to the patients rooms.

• All seven dewars within the cryostore were individually alarmed and linked to an autodial facility with the exception of the emergency tank. An out of hours rota is provided for responding to emergencies, a copy of which is also located at the main reception desk for the hospital. The door leading into the embryology laboratory has a keypad door entry system providing restricted access to authorised members of staff only.

• Emergency anaphylaxis and arrest trays are located within the operating theatre which are checked daily, with a full arrest trolley (evidenced as being checked daily) located along the corridor within the Cardiac Laboratory, but within close proximity to the unit should it be required. There are two advanced life support trained nurses employed for the unit with all other nursing staff trained to intermediate life support standard.

• Patients undergoing egg collection procedures are offered intravenous sedation only. An anaesthetist is present for all procedures. As a means of providing additional safety for patients, egg collections are only performed on days when the Nuffield Hospital main theatres were also in operation.

Areas for improvement • Fourteen staff (nursing and embryology) are required to share one office for their

administrative functions, telephone answering etc. Staff interviewed stated that this can contribute to higher stress levels within the staff due to overcrowding. It was recommended that the provision of additional office space be looked into urgently.

• Two low oxygen monitors were located within the embryology laboratory. One of the monitors was located outside the cryostore area. It was recommended that this be re-positioned to inside the cryostore to provide more effective warning against an oxygen depleted environment in this area.

Executive recommendations for Licence Committee None

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Areas not covered on this inspection All areas covered. Evaluation Some improvement required.

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4. Information Desired outcome: Information is relevant, clear and up to date for patients and the HFEA


� Information management � Information to patients and donors � Information to the HFEA registry and updates � Consent � Protocols � Record keeping

Outcome of audit of records The last HFEA operational audit was conducted in 2002 and therefore has already been covered during a previous inspection. Six sets of patient notes were reviewed during the course of the inspection. Findings are given below. Areas of firm compliance • Patient information provided pre-inspection was considered to be fit for purpose by the

inspectorate, provided to date information and was version controlled. Patients interviewed stated that they found the information to be informative and easily understood.

• Patient notes were held within secure storage at the reception area. It was reported by unit staff that notes are held n the unit for a period of two years after which, they are archived to off site secure storage.

• The HFEA Registry Department reported no problems from the centre. • Patient files examined during the course of the inspection were seen to contain all relevant

treatment and storage consents (both HFEA and unit specific), ‘Welfare of the Child’ assessments and consent to disclosure consents.

• There is a very robust quality manual in place containing all of the centre policies and protocols for all disciplines within the ACS. All policies were evidenced as being version controlled and contained review dates.

• Patient notes were seen to be held securely in locked cabinets within the main reception area. It was noted that records are kept on site for a period of two years after which they are archived to a secure off-site facility.

Areas for improvement • Female patients consenting to the male partners using their embryos posthumously are

not currently being screened or registered as donors. • During the review of patient notes, both the centres copy and the patient copy of HFEA

consent form 006 was found to be filed. This was brought to the attention of the PR who stated that this would be forwarded to the patients.

Executive recommendations for Licence Committee None

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Areas not covered on this inspection All areas covered. Evaluation Some improvement required.

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


� Assessment of patients and donors � Safe handling systems � Procedures in practice � Laboratory processes and practice � Clinical practice � PGD/ PGS � Recruitment and retention of staff � Staff competence, qualifications, training and CPD

Full time equivalent staff GMC registered doctors 4 NMC registered nurses 6 HPC registered scientists 2 Scientists working towards registration

2

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

2 x nursing care assistants, 1 x clerk, 2 x counsellors. (Note should be made that one counsellor will be retiring within the near future).

Summary of laboratory audit Details of the last laboratory audit were provided pre-inspection showing the following: -

• Frozen embryo tanks audited 21/12/06 • Frozen donor sperm tank audited 9/1/07 • Frozen donor sperm tank audited 18/8/06

Report stated that all samples were accounted for and all paperwork was in place. Summary of spot check of stored material Two sperm samples were tracked from the tanks to the records and two sperm samples were tracked from the records to the tanks. No discrepancies were recorded. Two embryo samples were tracked from the tanks to the records and two embryo samples were tracked from the records to the tanks. No discrepancies were recorded. Areas of firm compliance • Evidence was seen that daily checks of the incubator and hot block are made. A check is

made at the end of each day to ensure that all dewars are locked. • Patients and donors are screened and assessed as per the centres policies and protocols,

through taking full medical histories during consultation and from information obtained by referral letters.

• The centre follows the Nuffield Hospital policies and procedures for recruitment. • Training records reviewed during the course of the inspection contained evidence of

detailed induction programs, training needs analysis and competency sign offs. • All staff interviewed stated that they were well supported in their continuous professional

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development (CPD) training and by senior management. Evidence of ongoing CPD was seen in the training folders reviewed during the inspection.

• Evidence was provided that daily environmental checks were performed and recorded including the incubator and hot block temperatures.

• In 2006, the centre began recruiting sperm donors after advice was sought from a centre in Manchester. To assist with the additional workload that this entails, the centre has recruited a part time embryologist. Donors can attend the unit in the evening which has assisted the recruitment process. Donors are only paid expenses in line with the requirements of the SEED Regulations.

Areas for improvement • It was noted during the inspection that two microscopes were not within flow cabinets.

The inspectorate was advised that this will be remedied once the alterations to the laboratory are made in November 2007.

• It was established through interviews and observation that witnessing practices are conducted contemporaneously and in accordance with HFEA guidance, however the protocol and paperwork for witnessing did not capture all steps performed. This was brought to the attention of the senior embryologist and it was agreed that this protocol would be revised to reflect current practice.

• Air quality within the laboratory and treatment rooms do not currently meet with the requirements of the EU Tissue and Cells Directive. Plans have been presented to the HFEA showing that refurbishment of the laboratory and air handling processes are programmed to commence in November 2007 to enable these requirements to be met.

Executive recommendations for Licence Committee None Areas not covered on this inspection PGD/PGS are not performed at this centre. Evaluation Some improvement required.

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Report compiled by: Name TONY KNOX Designation Inspector Date 1st June 2007 Appendix A: Centre Staff interviewed Mr Robin Yates – Person Responsible 7 other members of the centre staff.

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Appendix B: Licence history for previous 3 years 2007 Licence Committee 14th May 2007. Application presented to vary the centres licence in accordance with the requirements of the EU Tissue and Cells Directive. Application was accepted and variation of licence approved. 2006 Licence Committee 13th September 2006. Application made to remove nominal licensee due to the fact that the post holder (Dr David Whiteoak) has resigned as General Manager and Nominal Licensee from the Hospital. 2004 Licence Committee 13 October 2004 Inspection 6th July 2004

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Appendix C: RESPONSE OF PERSON RESPONSIBLE TO THE INSPECTION REPORT Centre Number……………………………………………………………………………………… Name of PR…………………………………………………………………………………………. Date of Inspection………………………………………………………………………………….. Date of Response…………………………………………………………………………………… Please state any actions you have taken or are planning to take following the inspection with time scales I have read the inspection report and agree to meet the requirements of the report. Signed…………………………………………………………………………………………………… Name……………………………………………………………………………………………………. Date……………………………………………………………………………………………………… 2. Correction of factual inaccuracies Please let us know of any factual corrections that you believe need to be made (NB we will make any alterations to the report where there are factual inaccuracies. Any other comments about the inspection report will be appended to the report).

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

interim inspection report glasgow nuffield hospital acs 0115

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