New Premises Inspection Report. Assisted Conception Unit Chelsea and Westminster Hospital. Centre Date of Inspection: 30 September 2009

Transcription

1 New Premises Inspection Report Assisted Conception Unit Chelsea and Westminster Hospital Centre 0158 Date of Inspection: 30 September 2009 Date of Executive Licence Panel: 23 October 2009 Version: 1 Page 1 of 16

2 Centre Details Person Responsible Nominal Licensee Centre name Mr Julian Norman-Taylor Mrs Kathryn Mangold Assisted Conception Unit Chelsea and Westminster Hospital Centre number 0158 Centre address Type of inspection Inspector(s) Assisted Conception Unit Chelsea and Westminster Hospital 369 Fulham Road London SW10 9NH Variation to licence change to premises Gill Walsh Andrew Leonard Fee paid Licence Number N/A L0158/10/b Licence expiry date 30/11/2011 NHS/ Private/ Both Both Version: 1 Page 2 of 16

3 Index Centre Details...2 Index...3 About the Inspection:...4 Brief description of the Centre and background to inspection...5 Activities of the Centre for the time period from [insert relevant time period]...6 Summary for Licence Committee...6 Evaluations from the inspection...7 Breaches of the Act, Standard Licence Conditions or Code of Practice:...7 Additional licence conditions and actions taken by centre since last inspection.7 Report of inspection findings Organisation Premises and Equipment Clinical, laboratory and counselling practice... Error! Bookmark not defined. Report compiled by:...12 Appendix A: Centre staff interviewed...12 Appendix B: Licence history for previous 3 years...12 Appendix C: Response of Person Responsible to the inspection report...15 Version: 1 Page 3 of 16

4 About the Inspection: This inspection visit was carried out on 30 September 2009 and lasted for 4 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 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 Version: 1 Page 4 of 16

5 Brief description of the Centre The Assisted Conception Unit at Chelsea and Westminster Hospital has been licensed with the HFEA since 1995 and offers a comprehensive range of assisted conception treatments to both NHS and self funding patients and also viral positive patients. The centre is a self contained unit on the fourth floor of the Chelsea and Westminster Hospital and is part of the Chelsea and Westminster NHS Foundation Trust and conducts approximately 360 licensed treatment cycles per year. The Person Responsible (PR), Mr Norman-Taylor, is a consultant gynaecologist in the Trust who has held the post for a number of years and has successfully completed the HFEA Person Responsible Entry Programme (PREP). He is based at the centre for the majority of the working week and may be readily contacted by the team at times outside of this. The Centre informed the HFEA of plans to expand and refurbish the clinical and laboratory facilities in May 2009 by submitting an application to vary their licence to reflect this change. Included in the application were details of the proposed changes, loaded architects floor plans and a phased plan of works. The plan outlined a phased redevelopment as follows: 1. Temporary relocation of the cryostore for initial enabling works in that area. 2. Upgrading to facilities and décor in the patient waiting / reception area. 3. Creation of a back office space behind the new reception area. 4. Reconfiguration and refurbishment to the existing laboratory area to upgrade facilities and to provide facility for the isolation of potentially infectious tissue. 5. Reconfiguration of space to create a dedicated cryo store with integral alarm system and decant of the cry preservation storage tanks to the new area once completed. 6. Reconfiguration and refurbishment of the recovery area and treatment room to increase the number and space surrounding the recovery beds and improve patient privacy. 7. Reallocation of space to create a separate clinical store and clinical waste room. 8. Increase the size of the staff changing area. 9. Reconfiguration of space to create an open plan office area for centre staff. 10. Improve overall security to the centre by the installation of person specific swipe card access to all areas. The proposed temporary cryo store was briefly inspected by the executive prior to the move and was deemed to be suitable. The refurbishment work commenced on 6 July 2009 and has progressed well, with the contractors being on target to hand back the area to the Trust on 16 October 2009 with a view to full service recommencement in early November The purpose of the inspection was to evaluate the newly refurbished premises for suitability and readiness to recommence licensed treatment It is anticipated that the changes to the premises will accommodate an increase in the centre s capacity in time, figures for which have not yet been set. The PR stated that any increase will be gradual with an evaluation of material and human resources being conducted Version: 1 Page 5 of 16

6 at regular interval to ensure the centre works to an appropriate capacity. General areas of practice, including quality of service, information, clinical and laboratory processes were not reviewed at the time of this inspection as these will be addressed in the course of the interim inspection, to be schedule for later in the year when the centre has had the opportunity to embed into the refurbished accommodation. Activities of the Centre 1 for the time period from 1 June 2008 to 1 July 2009 In vitro fertilisation (IVF) 279 Intracytoplasmic sperm injection (ICSI) 137 Frozen embryo transfer (FET) 4 Intra uterine insemination (IUI) 7 Gamete intrafallopian transfer (GIFT) - Research - Storage gametes/embryos yes Summary for Licence Committee This inspection was to assess the appropriateness and suitability of the extended and refurbished premises, equipment and staffing with reference to the HFE Act HFEA Code of Practice 7th Edition and to assess the centre s readiness for the resumption of licensed treatment. In considering overall compliance the executive considers that it has sufficient information drawn from documentation submitted by the centre prior to inspection and from observations and interviews conducted during the inspection visit to conclude that: the existing and refurbished premises and equipment inspected are suitable for the treatment procedures for which the centre is licensed centre staff acting under the supervision of the PR are of sufficient number and are suitably trained and qualified for their designated roles. the executive is satisfied that the centre demonstrates appropriate practices in respect to air quality monitoring and laboratory, clinical and administrative procedures. the centre has submitted comprehensive documentation of a good standard in preparation for this inspection. The executive supports the centre s application to variation the centre s licence subject to the centre providing the executive with confirmation of the following actions prior to 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 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. Version: 1 Page 6 of 16

7 recommencement of licensed treatments; Confirmation that the access to the centre is controlled, access to the cryostore is restricted to authorised personnel only. Confirmation of validation, recalibration and testing of existing key equipment after it has been moved to the refurbished areas; Confirmation that all alarms and equipment monitoring systems have been checked and are working effectively, including the low oxygen and low nitrogen monitors/alarms; Evidence that air quality results for the laboratory areas demonstrate compliance with HFEA requirements Confirmation that the SOPs have been reviewed and updated where necessary to reflect the new environment; Evidence of microbiological validation following deep clean procedures. Evaluations from the inspection Topic No Improvements required Some Improvement required 1. Organisation 2. Quality of the service N/A 3. Premises and Equipment 4. Information N/A 5. Laboratory and clinical processes N/A Significant Improvement required 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;- No breaches of the Act or Code of Practice were identified in the course of the inspection Additional licence conditions and actions taken by centre since last inspection The current licence was inspected prior to licence renewal in March 2008: renewal was granted by Licence Committee without condition. Version: 1 Page 7 of 16

8 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 Leadership and organisation The Person Responsible continues to supervise activities at the centre and is supported by the Nominal Licensee. Laboratory Manager and the Lead Nurse have day to day links with the construction project lead. There will been no changes to the centre s management structure as a result of the refurbishment. Resource Management Details of additional facilities to be provided in the refurbished premises were included in the project plan and application and are described in the section Brief description of the centre. The centre does not currently anticipate the requirement of any additional key equipment at this time. The centre plans to recruit personnel to a small number of additional posts following the refurbishment. Risk Management At the time of the visit, construction works had resulted in some disruption to normal access / egress from within the centre for both staff and / or patients. Areas affected had been risk assessed by Trust health and safety personnel and access restricted / modified accordingly. Contingency The centre continues to be supported by the Trust emergency generator system and uninterrupted power supply (UPS) for key equipment during this time. Third Party Agreement The centre recognises that the introduction of any new supplier as a result of the Version: 1 Page 8 of 16

9 refurbishment will require establishment of additional third party agreement(s). There are no additional third party requirements at present. Areas for improvement None Areas for consideration Executive recommendations for Licence Committee Evaluation No improvement required Areas not covered on this inspection Clinical governance Incident management Alert management Complaints management Meetings / dissemination of information Payment of licence/treatment fees Version: 1 Page 9 of 16

10 2. 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 Premises overall Accesses to areas under development is restricted and was seen to be appropriately sealed, health and safety notices were in place. No licensed treatment has been conducted during the major phase of the refurbishment. Security The level of security implemented with the refurbishment was consider by the executive to be of a high standard. Access to the centre is sealed out of hours and controlled within the centre by personnel specific access swipe card. The PR stated that Trust security staff are to be re-orientated to the centre and receive update training in what to do (and not do) in the event of an alarm being triggered in the cryostore. Staff responding to an alarm out of hours would be accompanied by a security officer but neither would attend the centre alone. An SOP to cover this was seen to be in place. Readiness for licensed treatment On inspection the centre were able to provide a schedule for handover and re-commissioning of the refurbished areas in readiness to recommence licensed treatment which includes in sequence provision for; Initial deep clean in all areas Relocation of the cryo tanks to the new designated cyro store with commissioning and testing of low oxygen and low liquid nitrogen alarm systems (to be conducted by specialist service provider). Relocation of all required equipment and materials to new embryology and andrology laboratories. Servicing, recalibration and testing of equipment to be conducted by specialist service providers. 2 nd deep clean to clinical areas. Air quality and microbiological testing by Trust. Clinical facilities changes Patient areas have been remodelled and improvement made to patient area décor. A new treatment room and recovery area has been created with increased recovery space which Version: 1 Page 10 of 16

11 directly adjoins the treatment room. Laboratory facilities New laboratory areas have been constructed, the main IVF / ICSI laboratory includes an isolation area which will facilitate the treatment of viral positive patients. This laboratory has direct access to the treatment room. The semenology laboratory is relocated next to the new laboratory area and will has dedicated provision for male partner/donor sample production (x 2 rooms). There is a separate dedicated waiting area and consulting room. Equipment and Materials The centre does not anticipate that any new key equipment will be required as a result of the refurbishment at this time. All key equipment was decontaminated prior t ebing stored Relocated equipment will remain the responsibility of the Trust Bio Medical Engineering department for routine maintenance and portable appliance testing (PAT) prior to first use and annually thereafter. The safe movement, recalibration and testing of key existing equipment has been contracted to the equipment manufacturers. The movement of all equipment and materials has been risk assessed by the centre, evidence for which was seen. Storage Facilities for Gametes and Embryos As part of the refurbishment a new purpose designed cryo store for the storage of all gametes and embryos has been created. New, high capacity storage units are installed with appropriate low oxygen and liquid nitrogen alarms which also sound in the main laboratory and the hospital security lodge. Security staff are Staff Facilities There are enhanced staff facilities as part of the refurbishment plan with the provision of a dedicated staff rest room, staff changing and locker rooms and also several seminar rooms. Storage of Records Medial records for patients not currently in treatment have been decanted off site to a previously HFEA approved document storage centre. Current patient records were seen on inspection to be stored securely with access restricted to authorised personnel only. As part of the refurbishment plans there is to be a dedicated, secure medical records store within the centre. Areas for improvement Areas for consideration Executive recommendations for Licence Committee Prior to the commencement of licensed activity it is recommend that the following information and or confirmation is provided to the HFEA: Version: 1 Page 11 of 16

12 Confirmation that the access to the centre is controlled, access to the cryostore is restricted to authorised personnel only. Confirmation of validation, recalibration and testing of existing key equipment after it has been moved to the refurbished areas; Confirmation that all alarms and equipment monitoring systems have been checked and are working effectively, including the low oxygen and low nitrogen monitors/alarms; Evidence that air quality results for the laboratory areas demonstrate compliance with the requirements of A Confirmation that the SOPs have been reviewed and updated where necessary to reflect the new environment; Evidence of microbiological validation following deep clean procedures. Evaluation As there is still some construction work outstanding, some improvement is required in terms of the submission of information confirming outstanding actions when due prior to the commencement of licensable activity. Areas not covered on this inspection None Report compiled by: Name Gill Walsh Designation Inspector Date 10 October 2009 Appendix A: Centre staff interviewed The PR, Nominal Licensee, Lead Nurse and Laboratory Manager Appendix B: Licence history for previous 3 years 22 June 2009 Variation to have standard licence condition A.7.2(b) removed: that donors must be negative for HIV I & II : Anti HIV I & II denied. 15 December 2008 Variation Application to store eggs granted. Version: 1 Page 12 of 16

13 24 July 2008 Licence renewal granted without condition 21 November 2007 Application to import donor sperm - denied 26 July 2007 Variation pursuant to the Human Fertilisation and Embryology Act 1990, as amended by the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 granted. Executive update summary for Executive Licensing Panel 23 October 2009 Centre number 0158 Centre name Chelsea and Westminster Persons Responsible Mr Julian Norman Taylor Application for variation of the centre s licence to reflect a change to premises. Background Further to the inspection visit undertaken on 30 September 2009, the executive supported the centre s application to vary their licence subject to the centre providing the executive with confirmation of the following actions prior to recommencement of licensed treatments. The executive can confirm that evidence of the outstanding matters having been completed as requested has been received by the HFEA either via scanned documents sent via or in hard copy to the HFEA via courier. The executive therefore recommends that the Committee vary the centre s licence as requested without further condition. Requirement : Confirmation that the access to the centre is controlled, access to the cryostore is restricted to authorised personnel only. The centre have provided written sign off that electronic locks are in place and are working. Designated staff have access programmed into their ID badges. Requirement: Confirmation of validation, recalibration and testing of existing key equipment after it has been moved to the refurbished areas; The centre have provided documented evidence of the validation and recalibration of new and existing key equipment that has been moved. Requirement: Confirmation that all alarms and equipment monitoring systems have been checked and are working effectively, including the low oxygen and low nitrogen monitors/alarms; The centre have provided documentary evidence of succesful low oxygen and nitrogen alarm testing. Requirement: Version: 1 Page 13 of 16

14 Evidence that air quality results for the laboratory areas demonstrate compliance with HFEA requirements The centre have submitted documented evidence of laboratory and workstation air quality testing which demonstrates compliance with HFEA requirements. Requirement: Confirmation that the SOPs have been reviewed and updated where necessary to reflect the new environment; The centre have submitted details of the SOP s that required review or update to reflect the new working environment and are considered compliant. Requirement: Evidence of microbiological validation following deep clean procedures. The centre has submitted documented evidence of microbiological testing following final deep clean, the results of which are seen to be within acceptable range. Gill Walsh Inspector 20/10/09. Version: 1 Page 14 of 16

15 Appendix C: Response of Person Responsible to the inspection report Centre Number 0158 Name of PR Julian Norman - Taylor Date of Inspection 30 September 2009 Date of Response 6 November 2009 Via from PR Mr Julian Norman-Taylor (Trim) I can confirm that: Access to the ACU is controlled, and that access to the cryostore is restricted to authorised personnel only. Key equipment has been recalibrated and revalidated. Relevant certification has been forwarded to you. Low oxygen and nitrogen alarms are in place and checked. All SOPs have been reviewed and updated where necessary to reflect the new environment. The lab and theatre have passed Air Quality testing. Relevant Certification has been forwarded to you. The lab and theatre have passed Microbiological testing. Relevant Certification has been forwarded to you Version: 1 Page 15 of 16

16 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 Version: 1 Page 16 of 16

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