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New Premises Site Visit Report

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					                New Premises Site Visit Report
Name of Applicant          Homerton Fertility Unit

Address of Proposed        Homerton University Hospital
Premises                   Homerton Row
                           E9 6SR
Has the applicant been
licensed before            YES
If yes:                    0080
Centre Number and          Fertility Unit,
Address of previous        Homerton Row,
premises                   Hackney London,
                           E9 6SR
Inspector(s)               Bhavna Mehta
                           Sarah Hopper
Date of visit              23rd September 2008

Date of any previous       Interim Inspection: 26 February 2008
visits to these premises




SOP Number: RIF-06-Q                                              TRIM: 06/3138
Version: 0                                                           Page 1 of 8
About the Site Visit
The purpose of the site visit report is to confirm to the PR the findings of the inspection
highlighting areas of firm compliance and good practice, as well as areas where further
improvement is required.


Brief Description of the Centre
Homerton Fertility Unit (Centre 0153) holds a treatment and storage licence. The unit has
been licensed for treatment since 1995 and is located on the site of the Homerton University
Hospital NHS Trust. The unit is currently situated partly in port cabins and partly in a
permanent building. The unit treats NHS and self funding patients. 75 % of the work is NHS
based.

The current PR has been in place since December 2007 and has completed the PR entry
Programme satisfactorily. The PR is registered with the General Medical Council and is on
the obstetrics and gynaecology specialist register.

The Unit has submitted an application to vary the licence to:

    1. Re-locate the clinical and laboratory areas to new premises at the same address,
       Homerton University Hospital, Homerton Row, Hackney London, E9 6SR and
    2. Change centre name to Homerton Fertility Centre (from Homerton Fertility Unit).

The PR has supplied site plans for the new unit, new equipment list and a pre-inspection
report detailing the plans for the build, move, clinic and laboratory work.

The centre’s pre-inspection report states that the clinic work was moved to the new unit on
the 16th September 2008 but that licensed work is not being conducted at the new unit. The
report also states that licensed activity was stopped on the 12th September 2008 and will not
re commence until the licensing committee approves this variation. This move will mean that
the centre will encounter a decrease in patients being treated. To complete the NHS
contracts, the centre plans to increase their work load for number of cycles to about 70 a
month from November. To cater for this, the centre is increasing its staff numbers to a total of
4 full-time permanent embryologists from early October.




SOP Number: RIF-06-Q                                                    TRIM: 06/3138
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Details of the move

The clinical and laboratory work is to be moved to the new unit. The oocyte retrieval is to
continue to be conducted in the operating theatre in the Day stay unit which will now be closer
to the new unit and on the same floor.

The embryo and sperm storage only will not be moved and will be retained in the old unit, in
exactly the same place as it is currently housed. Freezing of embryos and gametes will be
carried out in the new unit and the frozen material will be taken down for storage in the
current premises. There will be a temporary storage facility in the new unit with separate
storage tanks for sperm and embryos. These tanks will be alarmed and monitored by the
Facility Monitoring System (FMS) along with the other equipment in the new unit. The frozen
material will be taken down to the main storage on a weekly basis.




Purpose of inspection
To assess the partial re-location to new, purpose built premises within the main hospital.

The new premises were inspected on 23rd September 2008. Other areas of practice,
including information, access to counselling and scientific practice within the centre, were not
inspected as these were addressed at the interim inspection on 26th February 2008.
Therefore, this report comprises an assessment of the proposed new premises only.




SOP Number: RIF-06-Q                                                     TRIM: 06/3138
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Summary of findings for Licence Committee
The re-location has been prompted by the need for the Centre to comply with the changes in
the law, in particular, the European Union Tissue and Cells Directives (EUTCD). The main
cryostore area is to be retained in the existing unit.

The executive are satisfied with the proposed new facilities and would recommend the
variation of the licence to reflect the change of premises, subject to receipt of confirmation
from PR that the following actions have been taken:

  • Validation and re-commissioning of key equipment before the move.
  • Testing of background and working environment air in all areas where gametes and
    embryos are processed which demonstrates that the air quality meets the requirements of
    Licence Condition A.10.19, Code of Practice Standard 6.3.6 (b), Standard 7.8.5 and
    Guidance 9.4.



The Licence Committee is asked to approve this new premises application and to vary the
licence with the change centre name from Homerton Fertility Unit to Homerton Fertility Centre




SOP Number: RIF-06-Q                                                      TRIM: 06/3138
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1. 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:
Suitable premises
Counselling facilities
Laboratory facilities
Air quality
Management of equipment and materials
Storage facilities for gametes and embryos
Staff facilities
Storage of records


Summary of Findings
The new premises are located on first floor of the hospital. The unit has been ‘purpose built’ to
provide infertility treatments. The move to new premises has been risk assessed by the
centre and the findings submitted to the HFEA as recommended in the Interim Inspection
Report dated 26th February 2008.

The entrance to the new premises is secure with staff access using a swipe card system.
Patients and visitors access the unit via an intercom with the reception staff via a videophone
system.

The new premises include:
   1. Counselling room which holds a lockable filing cabinet in which the counsellor will
      keep her notes. The counsellor will keep the key to the room and cabinet.
   2. Treatment room which is to be used for embryo transfers and IUIs. This room can be
      accessed via the patient changing room and the laboratory. Panic and low air
      pressure alarms have been fitted in the treatment room.
   3. Production/procurement room, with a hatch through to the seminology laboratory.
      At the time of inspection, a bell was still to be fitted which would alert staff when a
      sample is left in the hatch.
   4. Embryology laboratory is accessed via a key pad locked door and goes through into
      the treatment room. This laboratory is fitted with a low oxygen alarm. Two incubators
      from the existing premises were in place in the new laboratory. Two new double flow
      hoods were also already in place. However, these were all awaiting validation.
   5. Seminology laboratory. The centre plans to store two dewars in here – one of sperm
      and one of embryos. The laboratory manager stated that these will be fitted with low
      nitrogen alarms. The main dewars will continue to be stored in the current premises in
      the porta cabins. The freeze machine will be stored in this laboratory and all freezing
      of gamete and embryo will take place in here. Embryos will be put through freeze
      solutions and loaded into straws in the embryology laboratory, which will then be
      carried through to the seminology laboratory and put into the freeze machine to
      undergo freezing. Frozen embryos and gametes will be stored temporarily in the
      dewars within the seminology laboratory but on a weekly basis will be transferred to

SOP Number: RIF-06-Q                                                     TRIM: 06/3138
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       dewars in the main cryostore. The Laboratory manager explained that most transfers
       will be made using flasks filled with low nitrogen and on occasion the temporary
       dewars will be taken downstairs, in the lift, to the crystore. This method will be used
       when the dewars need topping up with nitrogen. With both methods, the inspectorate
       were assured that two members of staff will be involved for witnessing and safety
       purposes and that this process has been risk assessed.
    6. Theatre. Egg collections will continue to be carried out in the main day theatre. The
       inspectorate was advised that the air quality in the processing hood in the theatre is
       grade C (though there did seem a bit of uncertainty about this). The inspectorate
       advised that the air quality in the flow hood in the theatre be routinely checked as eggs
       are actually processed in this area.
    7. Cryostore. The inspectorate visited the original premises to see the cryostore area.
       The dewars were fitted with alarms and the inspectorate were informed that these
       alarms are connected to the autodial system. The staff explained that the original unit
       is fitted with intruder alarms and that the unit is securely locked.

Areas for improvement
   • Licence. The centre had displayed the current licence relating to the existing premises
      in the new premises. As these premises have not yet been approved by Licence
      Committee, the inspectorate requested the PR that either the licence be removed from
      the new premises, or that he displays a notice, within close proximity of the licence, to
      clarify that the licence is for the existing premises and that the new premises need
      approval of the licence committee and that an application has been made.
   • Embryology laboratory. The Inspectorate was concerned about the possibility of
      samples being confused by staff when working in the two new double flow hoods.
      Therefore, the inspectorate advised that the risks associated with two operators
      working within the new double hoods, on different procedures in this area be assessed,
      particularly with regard to witnessing.
   • Air quality in the laboratories is to be measured and results be submitted.
   • It was recommended that a programme of risk assessments be introduced for the new
      unit and that evidence of staff training on equipment is kept.
   • PR to submit evidence of validation reports on equipment.

The standard of the premises and equipment
Generally compliant with present Authority requirements.

Report compiled by:
Name: Bhavna Mehta
Designation: HFEA Inspector
Date: 25/09/08




SOP Number: RIF-06-Q                                                    TRIM: 06/3138
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 Appendix A: Centre staff interviewed
PR and other staff members.




 Appendix B: Licence history for previous 3 years
Licensing History

Centre: Homerton Infertility Unit
Number 0153

2008
Licence Committee 25 June 2008
    1. The Committee noted the breaches identified in the inspection report,
particularly the storage of cryopreserved material without written consent, which
is a breach of the Human Fertilisation and Embryology Act 1990.
    2. The Committee noted the Person Responsible’s response to the findings of
the report. It requested that the Executive monitors the resolution of these issues
and that the issues are considered as part of the forthcoming new premises
inspection.
    3. The Committee agreed that the centre’s licence should continue with no
additional conditions.

2007
Licence Committee Meeting 16 April 2007
The Committee decided to renew the centre’s licence for a period of three
years. This decision reflected the fact that although the centre has made many
improvements since the last inspection, there is still some work to do to achieve
complete compliance with the Code of Practice.


2007
December: New PR appointed (NL was acting as both NL and PR temporarily)




Appendix C: Response of Person Responsible to the inspection report

Centre Number……………………………………………………………………………… ………

Name of PR……………………………………………………………………………… ………….

Date of Inspection…………………………………………………………………………………..

SOP Number: RIF-06-Q                                                     TRIM: 06/3138
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Date of Response……………………………………………………………………………………


I have read the inspection report and agree to meet the requirements of the report.

Signed……………………………………………………………………………………………………

Name………………………………………………………………………………… ………………….

Date…………………………………………… …………………………………………………………

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.




3. Please state any actions you have taken or are planning to take following the inspection
with time scales




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




SOP Number: RIF-06-Q                                                     TRIM: 06/3138
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Description: New Premises Site Visit Report