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Licence Renewal Inspection Report for Treatment
and Storage Centres
Princess Anne Hospital Fertility Unit
0121
Date of Inspection: 2nd May 2006
Date of Licence Committee: 21st June 2006
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CENTRE DETAILS
Centre Address Princess Anne Hospital Fertility Unit
Level G. Coxford Road
Southampton
SO16 5YA
Telephone Number 023 8079 6980
Type of Inspection Renewal of Treatment and Storage Licence
Person Responsible David Howe
Nominal Licensee Professor Iain Cameron
Licence Number L0121-14a
Inspector(s) Sarah Hopper (Lead Inspector)
Elliot Lawrence
Marion Witton
Fee Paid - date 19th January 2006
Licence expiry date 31st October 2006
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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................................................... 7
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........................................................................................................................... 21
Appendix B........................................................................................................................... 22
Appendix C........................................................................................................................... 25
Appendix D........................................................................................................................... 26
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About the Inspection:
This inspection visit was carried out on 2nd May 2006 and lasted for 8 hours. The report
covers the pre-inspection analysis, the visit and information received between April 2005 and
May 2006.
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, recommendations or new 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
1. Centre 0121 was first established as a licensed centre in 1992 and currently
provides donor insemination and long-term freezing facilities for local patients.
2. The Centre is graded as a small sized activity centre and in the past year
(10/01/05-19/12/05) carried out 128 DI treatments for 56 patients.
3. The centre is based within the Princess Anne Hospital and comprises of two
treatment rooms, a waiting area, counselling room, two offices, men’s
production room and an andrology laboratory.
4. The Centre operates from Monday to Friday and opening hours are 9-5pm. The
centre is currently staffed, temporarily, by two locum clinicians, one nurse, one
andrologist and a counsellor. They are supported by a secretary. The Person
Responsible is based in the Fetal Medicine Unit of the hospital. His appointment
was approved by previous licence committees due to the support given by the
Nominal Licensee who has an extensive fertility background.
5. The centre has experienced difficulties previously and their licence was
suspended for a period of 3 months in 2004. A major consideration in the
suspension of the licence was the loss of key staff. Their licence was reissued in
October 2004 with additional conditions. Following the renewal inspection in
April 2005, in which significant improvements in the centre were noted, the
additional conditions were removed from the licence. During this inspection the
staff referred to past problems in the unit but reported that they are now a stable
unit.
6. Future plans for extending the treatment services provided by the centre are
currently under development. The PR would like to introduce IVF/ICSI treatments
and in June 2006 will be appointing a consultant who will develop and implement
these proposals. The centre has been advised to keep the authority informed of
the progress of the plans. The Nominal Licensee is aware of previous Licence
Committee advice which stated that the role of the Person Responsible will have
to be performed by someone else should the centre wish to offer treatments
other than donor insemination. It is planned that the new clinical position at the
centre will encompass the responsibilities of Person Responsible.
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Activities of the Centre: January 2005-December 2005
Licensed
None
treatment cycles
Donor
128
Insemination
Unlicensed Ovulation induction with
treatments clomiphene citrate or HMG
Research Yes
Storage Yes
Summary for Licence Committee
The inspection team recommends the renewal of the centre’s licence for a period of one year.
There will be a requirement for an inspection and variation of the centre’s licence should the
centre decide to offer further licensed treatments.
Risk Assessment
Based on current information the centre had a low risk status of 11%.
Overall judgement of the effectiveness of the centre
Some minor improvements required.
No Improvements required Some Improvement Significant Improvement
required required
Yes
Evaluations from the inspection
Topic No Some Significant
Improvements Improvement Improvement
required required required
1. Organisation X
2. Quality of the service X
3. Premises and Equipment X
4. Information X
5. Laboratory and clinical processes X
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Breaches of the Act or Code of Practice
Breach Action required Time scale
On occasion the process of Arrangements should be Immediately
cryopreservation of gametes made by the centre to ensure
and subsequent storage is availability of a second
not witnessed by two persons witness during all relevant
at the centre. There is an laboratory and clinical
absence of an appropriately procedures as delineated in
trained person who could act Directions D2004/4.
as a second witness from
14:30 each day.
Breach of Directions
D2004/4.7
During the spot check of The cryopreservation protocol 1 month
stored material it was noted should be amended to reflect
that a number of donor the directions D2004/4.7 and
samples only had two this should be incorporated
reference markers. into future practice.
Straws/Ampoules frozen for
donors should have three
pieces of identification – e.g.
hospital/unit number, freeze
record number and date of
freezing. Breach of Directions
D2004/4.7
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Recommendations Time scale
All relevant patient information and SOPs 3 months
need to be reviewed in light of SEED review
Consider participation in the United Kingdom 6 months
National External Quality Assessment
Service (NEQAS) andrology scheme as this
would provide performance assessment for
the andrologist who currently works
independently.
Generate and maintain a calibration log for 1 month
the oxygen monitor
Perform an audit of oncology and DI patient 3 months
records.
To require the implementation of a Immediate
comprehensive system to ensure the
separation between all screened and
unscreened samples.
Proposed licence variations
N/A
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Changes/ improvements since last inspection 28/04/05
Recommendation Action taken
More robust supervision should be The unit organised for the andrologist to
provided for the andrologist. spend three days per month working at a
unit in London to broaden his experience
The counsellor should establish a network The counsellor has established links with
with other infertility counsellors to provide a fertility counsellor in Salisbury and has
support and to facilitate training and joined BICA
professional development.
The following protocols and patient Protocols requested have been developed
information should be developed:
• Protocol for abandoning stimulated
cycles when the risk of multiple
pregnancies is high
• Protocol for how sperm is allocated
space in the dewars
• Protocol for calling up expiry dates
of samples
• Patient information for OHSS
The centre should carry out a risk The centre attempted a risk assessment
assessment on the use of unscreened on the samples but found that it would be
donor samples impossible to test these for possible
infection so instead have developed
information for prospective patients
discussing the risk allowing them to make
an informed choice.
Additional licence conditions and actions taken by centre since last inspection
C N/A
A Complied Y/N
C N/A
A Complied Y/N
C N/A
A Complied Y/N
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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
Monthly multi-disciplinary meetings are held. All members of staff including the Person
Responsible and Nominal Licensee attend the meetings and subjects including HFEA alerts
and Chair’s letters are discussed. These meetings are minuted and evidence of this was seen
during the inspection.
Although the PR is based within another department, staff are able to contact him between
meetings should they have any queries or concerns. The Nominal Licensee who has the most
senior reproductive medicine background is also available for all staff to contact.
All staff have access to the HFEA incident alerts and Chair’s letters. These are filed in the
secretary’s office and were evidenced during the inspection. Communications from the HFEA
are discussed during MDT meetings; minutes seen at the inspection confirmed this.
The unit carries out regular audits on the services it provides; an annual audit of the donor
insemination programme, an ovulation induction audit and a counselling audit were presented
during the inspection.
Payment of treatment fees to the HFEA is timely and the centre has no outstanding debts.
Areas for improvement
Currently the centre halts treatment when the andrologist or nurse is unavailable. This could
lead to disruption for patients but could also impact on the witnessing practices. Evidence of
the effect on witnessing was noted during the inspection (Section 5).
The centre does not have an internal patient questionnaire and relies on HFEA returns for
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information. The Person Responsible should implement a process for patients to feedback
their experiences and views of the service.
Risk management is governed by the Hospital’s Gynaecology and Obstetric risk committees.
Although these committees are regularly attended by the Person Responsible there is no
individual charged with the responsibility of disseminating risk information to the rest of the
team.
The Person Responsible has clear ideas for the development of the centre to include other
licensed treatments. However, these plans are not documented and have not been discussed
in detail with the team. So that all staff are aware and can be involved in the proposed
expansion of the centre a draft business plan should be defined and appropriately distributed.
Executive recommendations for Licence Committee
To note the absence of contingency plans for situations when members of staff are
unavailable either due to sickness, CPD or annual leave.
Areas not covered on this inspection
The recruitment policy, clinical governance policy and complaints log were not evidenced
during the inspection as this information is stored within the Trust database.
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
In the period 06/01/04 to 22/12/04 live births rates per DI cycle were 11.6%. The clinical
pregnancy rate resulting from treatment cycles in the past year, 10/01/05 to 19/12/05 was
10.9%. The clinic currently performs ICIs on all patients but plan to develop an IUI programme
in the future. To facilitate this the centre plans to send the nurse on an appropriate training
course.
The live birth results are just above the national average taking into account the aims and
objectives of the service.
Reference is made to the success rates (live birth rate) in the patient information.
Areas of firm compliance
The centre has clear written criteria for assessing the “Welfare of the Child” (WOC).
Information is also provided to patients regarding the issue of parental responsibility. Any
cases which cause concern are referred to the hospital ethical committee. To date no patients
have been refused treatment on the basis of “Welfare of the Child”.
During the inspection it was noted that patient and donor files are stored in securely locked
cabinets within the nurse’s office, counsellor’s office and laboratory. All persons who have
access to patient files are listed on their licence.
The number of ICIs carried out since April have reportedly decreased as a result of limited
availability of identity-released donors. The centre has addressed this problem and is
planning on purchasing donor samples en masse from US clinics. The PR is assessing the
financial impact of imports for patients and when finalised should add costs and relevant
information to their patient guide to DI.
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Since the last inspection four complaints have been received by the centre, all of the
complaints made were regarding the withdrawal of funding by the PCT for DI treatments and
as such out of the centre’s control. The complaints officer is a member of hospital staff
outside the fertility team. However, complaints received are fed back to the fertility team and
staff and patients have access to the written procedure for the recording of complaints.
Counselling facilities are advertised and the counsellor is available on two days a week.
During the inspection the counsellor submitted an audit of the counselling service. In the
period April 2005-March 2006 104 counselling sessions were provided, of these 36
appointments were with new patients. Based on the size of the centre this reflects a high
uptake of the counselling provision. There is no waiting list for patients requiring counselling.
The counsellor is supervised for 1 ½ - 2 hours a month.
Areas for improvement
Donor selection currently occurs at the time of treatment, just prior to the ICI, and this is
working well currently according to the fertility nurse. However, the centre was asked to
consider whether this practice may become more difficult if the number of available donors
decrease as they anticipate. Currently the patient information does not include references to
the limited donor choices patients may be presented with on the day of treatment. Although
this issue is explained during the nurse’s talk it may assist patients to have documented
advice on the procedure for selection of donors.
There is no counselling protocol, it was suggested that a written protocol is developed.
Executive recommendations for Licence Committee
None
Areas not covered on this inspection
Protection of children arrangements.
Patients were not interviewed due to unavailability. No clinics or treatments were being held
on the day of inspection.
Evaluation
Some improvements needed.
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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
Access to the centre is controlled by keypad access and the office and laboratory areas are
fitted with locks. Patient records are stored in the office and andrology laboratory and are held
within locked cabinets (See Section 2). The security of these areas is especially important as
a separate genetics laboratory is currently located within the unit.
The rooms used for treatment and semen collection were assessed as being comfortable and
private. The waiting area was seen to be adequate and patient information was available.
Within the waiting area the HFEA licence and patient complaints procedure are clearly
displayed.
The laboratory was considered to be fit for purpose with adequate space for processing of
samples. The area is well ventilated with three windows which can be part opened.
In total the unit has 14 storage dewars. These are kept within the laboratory and were found
to be securely locked. All the main storage dewars are alarmed and linked to an autodialler;
there is a rota for response to alarms. Documented emergency procedures for responding to
failure of or damage to storage vessels or systems have been produced. The centre also has
written standard operating procedures for the cleaning of vessels, filling vessels and securing
vessels. Measurements of nitrogen levels within the tanks are monitored and recorded and
the tanks are filled weekly. Evidence of this was seen during the inspection.
A low oxygen alarm is present in the laboratory and advice on response to its alarm is
included in an emergency situation protocol. During the inspection the andrologist was able to
clearly explain the response to an emergency situation and this complied with the submitted
protocol.
Emergency facilities are situated within a connecting ward in the hospital. They can be readily
located by any member of staff. Regular checks on the resuscitation equipment are made by
staff within the Trust. The documented record of these checks was seen during the
inspection.
Areas for improvement
It was recommended that the complaints poster and leaflets should include contact details for
the HFEA.
A log should be kept to document calibration of the oxygen monitor.
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Executive recommendations for Licence Committee
To note the requirement for a calibration log of the oxygen monitor
Areas not covered on this inspection
Evidence of equipment maintenance as this is controlled and stored by the Medical
Equipment Management Service (MEMS) working within the Trust.
Evaluation
Some improvements required.
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4. Information
Desired outcome: Information is relevant, clear and up to date for patients and the
HFEA
Summary of findings from inspection:
Information management
Information to patients and donors
Information to the HFEA registry and updates
Consent
Protocols
Record keeping
Outcome of audit of records
The inspection team reviewed ten patient records, six from patients undergoing donor
insemination and four long term freeze patient files.
One set of long term freeze notes had no freeze record or witness sheets; no explanation for
this was provided by the unit. In another set of long term freeze records a witness had not
signed the relevant section of the freeze sheet. This was a result of the absence of an
available witness at the time of placing the samples into the storage tanks. In a set of notes
from a patient undergoing donor insemination the consent to disclosure was not complete; the
patient had not consented for external parties to access their records. The PR noted this
discrepancy.
Areas of firm compliance
The Registry is satisfied with the information provided by the centre and mandatory forms are
returned within the established time scales. The EDI system has been set up and the centre
plans to commence using it for submission of data in the next month.
All the centres documents including Standard Operating Protocols and patient information are
version controlled. This was evidenced by the dated footnotes on each document.
Patient information was found to be comprehensive and includes guidance on the counselling
which is available in the centre. Information provided to patients storing samples includes the
risks of possible deterioration, loss of viability, cross contamination of gametes as a
consequence of storage.
Donors are given advice on the position of the HFEA register regarding circumstances under
which donor information may be disclosed. This information is included in the literature
provided to prospective donors.
Areas for improvement
Inconsistencies were noted between the patient information sheets and SOPs. The patient
criteria in the patient information states that the centre treats patients up to 45yrs old.
However the SOP states 40yrs.
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Patient information should include information on costs and waiting times of treatment.
Patient information and SOPS relating to donor recruitment and DI need to be updated in line
with the SEED review – namely the “ten family events” rather than “10 live birth events” limit
for donors.
Reference to OHSS should be included on the patient information sheet relating to Clomid
use.
The timelines of requirements to notify the HFEA of adverse incidents should be included on
the Incident protocol – 12 hours for verbal notification and 24hours for written reports.
Executive recommendations for Licence Committee
To require patient information and protocols to be reviewed
Propose that the centre performs an audit of their oncology and DI patient records.
Areas not covered on this inspection
N/A
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.
Summary of findings from inspection:
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 2 (locums at centre until June). Clinics are run on Tuesdays and
Wednesdays. Permanent post is currently being advertised
with interview planned on 19th June 2006.
NMC registered nurses 1 (working part time hours - 9:00-14:30)
HPC registered scientists 0
Scientists working towards 1 (full time 9-17:00)
registration
Support staff (receptionists, 1
record managers, quality
and risk managers etc)
Summary of laboratory audit
All stored sperm have been audited within the past 12 months, any samples past their storage
date have been removed. The unit also have responsibility for a dewar storing ovarian tissue.
An audit has not yet been performed on this tank as the centre was previously unsure of its
status (specifically whether or not the tissue contained mature gametes). This has now been
investigated and an audit of the tank is scheduled to take place in the next 12 months.
Summary of spot check of stored material
An audit of sperm samples from two donors from dewar to database and vice versa was
conducted. No discrepancies were detected. However, it was noted that all donor samples
seen during the spot check only had two identifiers recorded on the straws. The centre was
reminded of the need for three forms of identification e.g. patient/unit number, freeze code
and date of freeze.
Areas of firm compliance
The laboratory has a bring-forward system to identify patient samples close to the storage
expiry date. To evidence efficiency of this protocol three samples in the card index file were
spot checked and cross referenced to the excel database for all samples. No discrepancies
were noted.
The laboratory has a defined system which ensured that 10 live births per donor were not
exceeded. Documentation of this protocol was produced following the last inspection. The
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centre realise that this will need to be refined in accordance with SEED guidelines.
Protocols and patient information on ovarian hyperstimulation have been developed since the
last inspection. Although the risks of this are low within a DI programme, the unit is
particularly well supported for management of these cases as the hospital also comprises of
gynaecology and early pregnancy wards.
Relevant staff are registered with appropriate statutory bodies, this was confirmed prior to the
inspection by reference to the GMC and NMC websites. All staff interviewed were satisfied
with the provision for continual professional development (CPD). The nurse, for example, has
regular updates and supervision on ultrasound scanning and has attended BFS in 2006. The
andrologist has received support by attending a London fertility centre three times a month. It
is suggested that this arrangement continues and that the andrologist registers with United
Kingdom National External Quality Assessment Service (NEQAS) to support continuing
competency. The Person Responsible reported that when the centre expands to include an
embryologist further support for the andrologist will be provided.
Areas for improvement
Currently samples from donors and oncology patients are frozen in a vapour phase tank
before storage in designated dewars. Due to the urgency of oncology cases it is possible that
some samples may be frozen before screening results are received and therefore there may
be instances when screened and unscreened samples are frozen together. Although the
possibility of cross-contamination in vapour phase is theoretical it is advisable for the centre to
purchase a further dewar so that freezing of unscreened and screened samples can be
conducted separately.
According to the laboratory protocol if during the six month quarantine period a patient sero-
coverts, their samples are to be moved into the quarantine dry shipper. However, this tank is
often in use, storing temporary quarantined samples for urgent oncology patients. Although
theoretical there could be a minimal risk of cross contamination. A system should be
established which enables separation of samples with viral status. It was recommended by
the inspectors that the purchase or acquisition of another storage tank could provide this
emergency storage space.
There are clear protocols for the import and export of gametes within the UK. However, as the
centre proposes to import donors from overseas in the future, it is suggested that the
procedure for applying for Special Directions is added to the import protocol. Since the
inspection, information regarding Special Directions has been provided to the centre which
should assist with this.
The andrologist works at the centre from 9-5pm and samples may be processed throughout
the whole day. However, it was noted that he is frequently the only member of staff on duty
from 14:30, from this time there is no availability of staff to act as a witness. Consequently
certain procedures may not be appropriately witnessed and evidence of this was found during
the inspection. Furthermore the safety of working alone in a cryostore should be considered.
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Executive recommendations for Licence Committee
To require the implementation of a comprehensive system to ensure the separation between
all screened and unscreened samples.
To require an arrangement of witness cover for the andrologist from 14:30 each day.
Note the non-compliance with D2004/4 regarding the level of information needed on donor
sperm samples stored.
To suggest that the andrologist joins the NEQAS scheme as this will provide performance
assessment.
Areas not covered on this inspection
Unit recruitment policies, these are managed by the Trust.
Evaluation
Some improvement required
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Report compiled by:
Name: Sarah Hopper………………………………………….
Designation: Inspector ……………………………………….
Date: 31/05/06……………………………………………………………
Appendix A: Centre Staff interviewed
PR: David Howe
NL: Professor Iain Cameron
5 members of staff.
Conflicts of interest: Iain Cameron is a Member of the HFEA.
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Appendix B: Licence history for previous 3 years
LICENSING HISTORY
Centre: The Princess Anne Hospital Fertility Unit
Formerly: Wessex Fertility Unit
Centre Numbers: 0121
_____________________________________________________________
First licensed 31 July 1992
Until February 2004, centre 0121 has been linked with centre 0057. The 2 centres were
inspected together and licensed for a full range of infertility services. The PR and most of the
staff were also common to both centres. NHS patients received DI and private patients
received all licensed treatments available.
In February 2004, centre 0057 moved premises to a purpose built centre and the two centres
became separate units at this time.
2005
Licence Committee 11th July 2005
The Licence Committee agreed to renew the centre’s licence for a period of 12 months.
The Committee agreed to the removal of the centre’s current additional condition and to the
inclusion on the centre’s licence of storage of ovarian tissue.
Inspection visit 28th April 2005.
2004
Licence Committee 25 October 2004
The Committee decided:
That the centre’s licence be renewed for 12 months for donor insemination and storage of
sperm.
That the following three additional conditions be included on the licence:
1) The Person Responsible must ensure that the andrologist is trained and competent as
detailed in part 1.14 of the Code of Practice (6th edition). When training is complete an
appropriate external scientist, identified by the Person Responsible, should inspect and report
that this level of competency has been achieved. This person should not have been involved
in providing training for the andrologist. This report should be sent to the HFEA Executive.
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2) A counsellor should be identified and in place to offer counselling as required in the Code
of Practice. The counsellor’s cv should be submitted to the HFEA Executive.
3) A protocol for interviewing patients to collect their personal data should be developed and
submitted.
The centre should not carry out any licensed treatment until the above documentation has
been submitted and approved by the HFEA Executive.
Licence Committee 29th July 2004
The Licence Committee considered the risks at the centre which included no andrologist or
counsellor being employed, and no annual audit of stored material taking place and decided
to suspend the centre’s licence until 31st October 2004.
The Committee agreed that Special Directions should be issued to ensure the continued
upkeep of the dewars on the premises. The centre should continue to work to resolve the
problems at the centre during this time. The Executive should continue to support the centre
to achieve the changes as detailed in the plan of action submitted by the centre.
Licence Committee 12th July 2004
The Licence Committee agreed to issue a temporary licence for 3 months to allow for due
process
Licence Committee 10th June 2004
The Committee considered the centre’s application and agreed to vary the licence to
recognise the change of name of the premises with immediate effect. Centre 0121 will now
be known as the Princess Anne Hospital Fertility Unit.
Licence Committee 5th April 2004
The Committee noted that Mr Howe has no experience in the field of infertility. The Committee
also noted that Dr Susan Ingamells would be running the clinical service and Professor Iain
Cameron would be in a position to advise. The Licence Committee agreed to vary the licence
to recognise Mr David Howe as Person Responsible and Professor Iain Cameron as Nominal
Licensee.
Licence Committee 26th February 2004
The Licence Committee agreed to vary the licence as requested when confirmation has been
received by the Executive from Susan Ingamells that she is willing to accept the role of
Person Responsible in place of Gordon Masson.
David Howe was appointed Nominal Licensee in place of Chantal Simonis.
The inspection on the 10th of March was cancelled. Inspection date for the licence renewal is
the 8th April 2004.
Inspection date for license renewal is 10th of March, particular emphasis must to given to the
suitability of the new premises with particular regard to emergency facilities now that the
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centre will no longer be within a hospital.
The following licence history refers to centre 0057 and 0121 as they were linked at this
time.
2003
Licence Committee 18th December 2003
The Licence Committee agreed to vary the licence to recognise the change of premises of
centre 0057 from 18th January 2004 from:
Wessex Fertility Unit
BUPA Hospital Southampton
Chalybeate Close
Tremona Road
Southampton
SO16 6UY
to:
Wessex Fertility Limited
Anglesea House
72-74 Anglesea Road
Southampton
SO15 5QS.
Licence Committee 7th October 2003
The Licence Committee agreed to recognise Cheryl Jackson as an ICSI practitioner under the
standard licence conditions.
Licence Committee 14th August 2003
The Committee agreed to grant a three year licence for project R0142, set no additional
conditions and made no recommendations – awaiting a second meeting so all paperwork
submitted on day can be thoroughly checked.
License Committee 7th April 2003
The Committee agreed to renew both licences with no additional conditions for one year (to
31.07.04), but with six additional recommendations.
Licence Committee 10th March 2003
The Committee agreed
Inspection visit 31st January 2003
2nd part of a two-part inspection of 11th December 2002. Clinician-only
Licence Committee 29th January 2003
The Centre requested that their name be changed on their licence following a decision by BUPA to
remove the name Chalybeate. The Committee approved the renaming of the Centre to “BUPA Hospital
Southampton”.
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Appendix C:
Statistical assessment of the success rates of the centre and the response to the
Patient Questionnaires. Please note that these assessments have been generated
using unverified data which has not yet been subjected to rigorous Quality Assurance.
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Appendix D
RESPONSE OF PERSON RESPONSIBLE TO THE INSPECTION REPORT
Centre
Number…………0121……………………………………………………………………………
Name of PR…………David Howe……………………………………………………………….
Date of Inspection…02.05.2006…………………………………………………………..
Date of Response…30.05.2006………………………………………………………
Please state any actions you have taken or are planning to take following the inspection with
time scales
Thank you for the suggestions made in this inspection report. The following changes have
been made or are planned:
Actions taken immediately:
1. Routine double witnessing of cryopreservation: arrangements have been made to
ensure that patients come earlier in the day when other staff are available to act as a
second witness. In emergency cases after 2.30pm when the part-time staff leave,
other staff on the licence will be contacted to act as a witness.
2. Identification markers on donor straws: the identification markers on existing donors
were those used before the current PR took on this role. We only recently started to
recruit new donors and they have 3 markers on straws: the donor coder, date of freeze
and hospital number.
3. A calibration log has been added to the tank top up log chart
Actions to be taken in the near future:
1. Separation of screened/unscreened samples: A small dewar will be purchased to use
for unscreened samples within 1 month.
2. Patient information and SOPs will be reviewed and amended in the light of the SEED
review within 3 months.
3. An audit of oncology and DI patient records will be carried out within 3 months.
4. The andrologist will take part in the NEQAS scheme within 6 months.
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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).
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 this section of the report to:
Dr Marion Witton
Head of Inspection, HFEA
21 Bloomsbury Street
London
WC1B 3HF
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