CARE at The Sheffield Fertility Centre (0061)

2005-07-14, Renewal report, centre 0061, final version, DB 1

Human Fertilisation and Embryology Authority

Report of a renewal inspection at

CARE at The Sheffield Fertility Centre (0061)

on

14th July 2005


Contents

Key facts about the centre.................................................................................. 3

Summary............................................................................................................ 4

Background to inspection ................................................................................... 6

The centre’s context ........................................................................................... 6

Type of work carried out ..................................................................................... 7

Staff .................................................................................................................... 7

The premises, equipment and other facilities ..................................................... 9

Clinical, nursing and laboratory procedures ..................................................... 10

Procedures for assessing clients and for assessing and screening donors ..... 11

Counselling process and facilities .................................................................... 13

Patient experience............................................................................................ 14

Record keeping procedures ............................................................................. 16

Three embryo transfer arrangements............................................................... 17

Audit ................................................................................................................. 17

HFEA register................................................................................................... 17

Clinical governance .......................................................................................... 17

Breaches of the Code of Practice or Act .......................................................... 18

Compliance with previous conditions and recommendations ........................... 18

Key points for the Licence Committee ............................................................. 20

Appendix A The inspection team and staff interviewed .................................... 21


Key facts about the centre Centre name

CARE at The Sheffield Fertility Centre

Centre address

24-26 Glen Road Sheffield South Yorkshire, S7 1RA

Centre number

0061

Person responsible

Elizabeth Lenton

Nominal licensee Simon Fishel

Activities of centre

2004/5 Licensed treatment cycles

IVF ICSI FET Egg sharing Egg donation donor recipient

186 174 131 35 5 4

Donor Insemination

22

Unlicensed treatments

Ovarian stimulation IUI

Research None Storage Yes

Focus of inspection

General

Additional licence conditions

None

Licence expires 31 December 2005


Summary 1. The centre was first licensed in 1992 and provides self funding and NHS

commissioned treatments to patients largely drawn from the local and surrounding areas. The centre provided approximately 500 licensed treatments in the time covered by this report.

2. The centre has experienced a period of relative stability in relation to

staffing. An accredited consultant has recently resigned from his post and the centre is in the process of recruiting a replacement. The embryology team has been expanded in the period covered by this report and a counsellor was recruited to replace a member of staff who had resigned at the time of the last inspection. Staff receive good opportunities for training and professional development and are subject to an annual appraisal. The centre also has a well developed induction programme for new members of staff.

3. Two issues were identified and discussed on the day of the inspection and

these are summarised below. • Members of the nursing team perform ultrasound scanning but at the

time of the inspection, were not working towards accredited ultrasound qualifications. Since the inspection, the centre has taken steps to comply with this requirement (see paragraph 45).

• Members of the nursing team obtain consents to treatment from patients. Subsequent to the inspection, the centre has considered Department of Health and GMC guidance and carried out a review of the process by which patients give consent. As a result of the review, a new training programme on obtaining consent has been established (see paragraph 46).

4. A review of the centre’s counselling procedures was completed in a

telephone interview with the centre’s counsellor. The counsellor carries out some routine assessment of patients in the course of providing counselling (see paragraph 65). The centre should review this practice.

5. The centre’s standard operating procedures and patient information are clear and comprehensive. Some omissions were identified during the evaluation of the centre’s documentation and these are listed in paragraphs 55, 60, 61 and 75 to 77. The centre should revise patient information and protocols as described to ensure compliance with the requirements of the 6th Code of Practice (COP).

6. The centre is proactive in the development of risk management processes.

Outcomes are audited regularly and the laboratory carries out a broad range of quality assurance checks. Complaints and incidents are managed appropriately and effectively within prescribed timeframes. The centre also responded very rapidly to address issues raised during the inspection and following their review of the draft report.


7. The centre wishes to be licensed for the storage of eggs (patient and donor). The centre has appropriate patient information on egg freezing and laboratory protocols for the procedure. The Licence Committee is asked to consider varying the centre’s licence to include this treatment.

8. The inspection team supports the variation of the centre’s licence and the

renewal of the centre’s licence for three years.


Background to inspection 9. This report covers the period from July 2004 to July 2005. 10. Patient questionnaires were distributed in the six months preceding the

inspection. 11. One site visit took place on 14 July 2005 and lasted 8 hours. The centre’s

counsellor was not available on the day of the inspection and this aspect of the centre’s service was addressed in a telephone interview with the counsellor on 22nd September 2005.

12. The report was reviewed by the centre in October 2005.

The centre’s context 13. The centre provides self funded and NHS treatment to patients referred from

the local area. Approximately 70% of the centres patients are self funding and the remaining 30% are funded through NHS commissioning arrangements with Rotheram, Doncaster and North Derbyshire primary care trusts (PCTs). Between one and ten patients are referred to the centre from overseas annually.

14. The centre operates between 0800 and 1700 Monday to Friday. Staff work

flexible hours to maintain appropriate staffing levels. Embryology and nursing staff work on Saturday mornings to cover essential activities but no invasive procedures are performed at weekends. Staff occasionally work at other CARE centres.

15. The centre is experiencing a period of stability but is anticipating that

implementation of the European Tissue Directive is likely to impact on the centre. An accredited consultant has recently resigned from his post and the centre had not recruited a replacement at the time of the inspection. As an interim measure, staff from other CARE facilities will support clinical services.


Type of work carried out

Licensed treatment 16. The centre carries out the following licensed treatments

• Storage of sperm (patient) • Storage of sperm (donor) • Storage of embryos • Donor insemination (DI) • In vitro fertilisation (IVF) • IVF with donor eggs • IVF with donor sperm • Intra cytoplasmic sperm injection (ICSI) • ICSI with donor sperm • ICSI with donor eggs • Chemical assisted hatching • IVF with egg sharing

The centre wishes to be licensed for storage of eggs (patient and donor). The centre has appropriate patient information on egg freezing and laboratory protocols for the procedure. The Licence Committee is asked to consider varying the centre’s licence to include this treatment.

Treatments that do not need a licence 17. The centre provides ovarian stimulation and intrauterine insemination (IUI)

treatments.

Staff 18. The centre has had a stable staffing structure over the time covered by this

report and all members of the team have opportunities for continued professional development and training. The accredited consultant has resigned his post and the centre is in the process of recruiting a replacement.

Staffing profile Person responsible Elizabeth Lenton Nominal licensee Simon Fishel Accredited consultant 3 Embryologists 4 (1 senior, 1 qualified, 2 trainee) Endocrine technician 1 ICSI practitioner 3 Nursing staff 7 Nursing assistant 1 Independent counsellor 1 Complaints manager Joanne Day Regulatory manager 1 Fertility-coordinator 1 Patient services 6


19. The centre has recruited an additional trainee embryologist and an

independent counsellor since the last inspection. The number of treatment cycles carried out is unchanged from the previous year.

Professional registration and continuing professional development (CPD) 20. The centre has a written recruitment policy and inspection of human

resources files confirmed that this policy is implemented. All staff are subject to criminal records bureau checks and sign a declaration to confirm that they will inform the PR if they are charged with any criminal activity.

21. All clinical staff are registered with the General Medical Council. All nursing

staff are registered with the Nursing and Midwifery Council. State registered members of the embryology team are registered with the Health Professions Council and two trainee embryologists are working towards state registration by the completion of the Association of Clinical Embryologists certificate. The counsellor is a member of the British Psychological Society (BPS) and of the British Association for Counselling and Psychotherapy (BACP). She works within the BPS Code of Ethics and the BACP Ethical Framework for Good Practice in Counselling & Psychotherapy

22. All newly recruited staff take part in an induction programme and maintain a

log of training that is reviewed at the end of a six month probationary period. Members of the team receive mandatory annual training in manual handling, fire safety, health and safety, and resuscitation. Staff attend meetings and conferences appropriate to their specialist roles and provide feedback on learning to the rest of the team. Staff are subject to annual appraisal and evidence of this was seen in human resources records.

23. The CARE organisation has a comprehensive patient data base system and

outcome data recorded on the system are analysed by treatment category, embryologist and treating clinician. These data are reviewed on a monthly basis by the unit’s management team and across the organisation at bi-monthly heads of unit meetings.

24. The centre holds regular multi-disciplinary team meetings which are

attended by members of the senior management team. These meetings are a forum for the discussion of management issues, finance, outcome statistics, policy, HFEA alerts, incidents and staffing. Minutes are taken at these meetings and information is disseminated to other team members by the senior managers.


The premises, equipment and other facilities

Premises 25. The premises are suitable for purpose. The entrance to the unit opens into

a reception area with a reception desk and an administration area. Since the last inspection, patient records have been removed from the administration area behind the reception desk and are stored in a locked room off the administration area. Also on the ground floor is a spacious and comfortable waiting area for patients, a scanning room, laboratory, a treatment room and office space. Some records are stored in the basement which has a key pad entry system.

26. The first floor of the building comprises three recovery rooms, a

theatre/procedure room that is connected to the laboratory suite, an additional procedure room, a sperm production room, toilet facilities, a conference room and office space for the PR and the egg donation coordinator.

27. Separate disability access is provided to the ground floor. 28. A small building in the grounds of the clinic is used as a staff facility

providing a kitchen, rest area, changing rooms, toilet facilities and office space.

29. The centre’s HFEA licence, CHAI registration document and complaints

policy are clearly displayed in the waiting room.

Equipment 30. The laboratory has been refurnished over the last year. A new change over

unit has been installed on carbon dioxide cylinders used to gas the laboratory incubator and a new incubator has been purchased.

31. Equipment is serviced and maintained annually and maintenance contracts

are in place.

Security 32. Security is appropriate.

Confidentiality 33. Patient records are secure and are only accessible by centre staff.

Arrangements for collecting sperm samples 34. Arrangements for collecting sperm are appropriate. Labelling of the

collection pot is checked and witnessed and the sperm production room has a system for alerting a member of the laboratory staff to the presence of a sample in the production room. On the rare occasions that sperm is produced off site, patients are asked to complete a declaration of the provenance of the sample.


Cryostore facilities, oxygen and dewar alarms 35. Gametes and embryos stored in a designated security area with controlled

access. 36. Cryostore facilities are adequate for the type and volume of activities that

are carried out. 37. Dewars are alarmed and the laboratory is fitted with a low oxygen level

alarm. Alarms are connected to an auto dial out system. 38. There are appropriate emergency procedures to respond to damage to

storage vessels and failures in storage systems. 39. There are appropriate emergency procedures to respond to low oxygen level

alarms.

Emergency facilities 40. The centre has a written policy for the admission of patients to NHS facilities

with full critical care facilities. 41. The centre has resuscitation equipment on site and staff have received

basic life support training.

Clinical, nursing and laboratory procedures 42. Standard operating procedures and protocols are version controlled and

show evidence of revision.

Clinical and Nursing 43. Clinical and nursing protocols are combined. Protocols are appropriate and

reflect current practice. 44. Procedures for the management of ovarian hyperstimulation syndrome are

appropriate. 45. Members of the nursing team perform ultrasound scanning. They receive in

house training and are mentored and supervised by experienced members of the team until their competence is assured. Sections 1.8 iii of the COP states that all nursing and midwifery staff are expected to be appropriately qualified and registered by the Nursing and Midwifery Council (NMC), to be experienced in women’s reproductive health and to be working towards (iii) An accredited ultrasound course/qualification, if involved in that procedure. To ensure compliance with this requirement, a member of the team has been enrolled on an accredited ultrasound scanning course. The NHS training facility will only allow one nurse from the centre to undergo training but this individual will mentor other members of the team when she has completed the course.


46. Members of the nursing team obtain consents to treatment from patients. Department of Health Guidelines1 state that the clinician providing the treatment or investigation is responsible for ensuring that the patient has given valid consent before treatment begins, although the consultant responsible for the patient’s care will remain ultimately responsible for the quality of medical care provided. GMC guidance2 states the task of seeking consent may be delegated to another health professional as long as that professional is suitably trained and qualified; has sufficient knowledge of the proposed investigation or treatment and understands the risks involved; acts in accordance with GMC guidance.

47. Since the inspection, the Medical Director has undertaken a review of the

consent procedure and a new training programme for nurses obtaining IVF and procedure consents has been established.

Laboratory 48. Laboratory protocols are comprehensive and reflect current laboratory

practice. 49. There are written standard operating procedures for: cleaning vessels; filling

vessels; securing vessels; freezing and thawing procedures; location and duration of storage; and handling of contaminated samples.

50. Witnessing procedures are appropriate and are documented in patient

records. 51. The centre stores a small number of samples for patients who have had

treatment that may impair their fertility. Samples of this material are stored in two locations.

Procedures for assessing clients and for assessing and screening donors

Welfare of the child 52. The centre has an appropriate process for conducting a welfare of the child

assessment. Patients are asked to obtain a report from their GP before treatment begins and a detailed medical and social history is obtained from the patient. This information addresses

a. the commitment to raise children b. ability to provide a stable and supportive environment for a

child/children c. immediate and family histories d. age, health and ability to provide for the needs of a child/children

1 Department of Health, Good Practice in Consent Implementation 2 General Medical Council, Seeking patients’ consent: the ethical considerations, November 1998


e. the risk of harm to children including inherited disorders (or transmissible diseases), multiple births, neglect or abuse, the effect of a new baby or babies upon any existing child of the family

53. The written protocol for the assessment of the welfare of the child outlines

the procedures to be followed in circumstances where concerns are raised or there is an absence of supporting information.

54. At the time of the inspection the written welfare of the child assessment

protocol did not specify the conditions under which the assessment should be repeated. The centre revised the protocol to include this information following the inspection and submitted a copy of the revised protocol to the HFEA.

55. Patient information about the use of donor sperm and for recipients of

donated eggs provides information on parental responsibility. Information for patients using donor sperm should be updated to reflect the changes in parental responsibility introduced in the Adoption and Children Act of 2002. Section 111, of the act states that an unmarried father shall acquire parental responsibility for the child if he becomes registered as the child's father. The centre confirmed that this change is being considered by the CARE organisation. When the review of this information is completed the centre should submit any revised information to the HFEA.

Ethics committee 56. The centre has access to an ethics committee. The committee is asked to

provide guidance when a decision cannot be reached after discussion of a case by a multi disciplinary team of the centre’s staff.

Assessing and screening donors 57. The centre buys sperm supplies from a sperm bank. 58. Centres supplying sperm inform the embryologist when a donor has

achieved ten live birth events. This is documented in all records and the sperm is not used after this notification is received.

59. The centre uses imported sperm and inspection of patient records showed

that the centre complies with the requirements of import directions. 60. Counselling services are referenced in information for patients considering

egg donation and sharing. Patient information states that counselling is mandatory for egg share donors and patients using donated sperm. The centre should clarify the patient information to reflect whether counselling is mandatory for the recipients of donated eggs or for egg donors.

61. Information for patients considering treatment with donated embryos does

not reference any of the screening tests carried out, how donors and recipients are matched, legal issues and issues relating to consent and the HFEA register or counselling. The centre should revise this information to


the high standard of other documents intended for patients considering treatment with donated gametes.

Counselling process and facilities

Counselling protocols 62. Implications and support counselling is available to individuals and couples

before, during and after treatment. The counsellor is able to provide patients with details about other counselling and patient support organisations. Reference is made to the availability of counselling in some but not all patient information however, a separate information leaflet entitled ‘The Counselling Service’ is available to patients.

63. The centre’s counselling leaflet includes the name of the qualified

counsellor, explains the counsellor’s role, when the counsellor is available and how to access the service.

64. The counsellor is involved in assessment as follows:

• Specific cases where WOC concerns have been identified by other staff. In such cases the individual / couple concerned are aware that involvement of the counsellor is expressly for the purposes of assessment and reporting.

• Cases where clients attend for the purposes of counselling (support, implications or therapeutic) and in the course of discussions disclose information of relevance / concern to the WOC. In such cases the counsellor discusses with the individual/couple the necessity (and their consent) to report the information.

65. The counsellor completes a form entitled “appointment with infertility

counsellor” which has a section for the counsellor’s assessment of the client’s smoking, drinking, criminal convictions, commitment and existing children. The centre should review the counsellors involvement in assessment of clients to ensure compliance with the requirement of section 7.1(iii) of the COP.

Counselling referral arrangements 66. Clients can refer themselves to the counsellor or be referred by medical and

nursing staff. Appointments are arranged by clinic staff in consultation with the counsellor as necessary. Arrangements are in place for staff to contact the counsellor outside her working hours in cases of urgency.

67. There is no additional charge for counselling or limit on the number of

sessions provided.

Supervision and professional registration 68. The counsellor has a degree in psychology and a diploma in counselling for

healthcare practitioners. She has worked at the Centre for 9 months and has other counselling experience (18 months as a GP counsellor). She is a


member of the British Psychological Society and of the British Association for Counselling & Psychotherapy and works within their respective Code of Ethics and Ethical Framework. Professional counselling supervision (1.5 hours per month) is provided by an independent practitioner who also works within the BACP Ethical Framework for Good Practice. The counsellor funds her own supervision.

Counselling audit 69. The centre submitted a counselling audit with the renewal application. A

total of 139 counselling sessions were provided over the period covered by this report. During this time the centre treated 514 patients. From the statistics available for the present counsellor’s first 6 months in post (October 2004 April 2005) a total of 106 counselling sessions were provided, of which 50% were for implications counselling and 50% for support counselling. The counsellor reports that most implications counselling sessions are attended by couples and are single sessions with ongoing sessions predominantly providing support counselling for individuals.

70. In feedback gathered by the HFEA from 72 patients who received treatment

at the centre over the last two years, 83% of respondents reported being made aware of the counselling service although 53% of respondents reported that the counselling service was not readily accessible. However, on review of the draft report, the centre commented that all patients get two written and at least one verbal piece of information about the counselling service. Patients interviewed on the day of the inspection were aware that the service was available. One couple had used the service and had found it accessible.

Location of counselling facilities 71. The centre does not have a dedicated counselling room. The facility

provided is multi-functional and is adequate for its purpose, ensuring privacy and confidentiality.

72. Counselling records are stored in a locked cabinet in the regulatory

manager’s office, and are accessed solely by the counsellor. The regulatory manager holds a key to the records cabinet for access in the event of an emergency such as the counsellor’s sudden incapacity.

Patient experience

Patient feedback 73. The centre has a patient questionnaire which is given to all patients on

completion of their treatment. 74. The centre distributed 200 HFEA patient questionnaires in the two years

preceding the inspection and a total of 72 responses have been received to date. The respondents were overwhelmingly positive about their experiences with 52 patients having compliments about their care and only 3


patients having any complaints. The only significant number of negative comments related to the availability of counselling (see paragraph 70).

Patient information 75. Information for patients is clear and comprehensive and complies with the

requirements of the COP with the following exceptions; • Information relating to the side effects of multiple pregnancy does not

reference the increased risk of raised blood pressure, reduced birth weight or prolonged stays in hospital. The centre reported that this information is given verbally at the medical consultation;

• Information on the freezing and thawing of embryos and gametes does not reference the risk of dewar failure or the possibility of cross contamination between samples. However, the frozen embryo replacement consent and IVF consent forms do reference this risk;

• Information does not advise patients that they may withdraw their consent to treatment or storage at any time until the embryos or gametes are used although this is addressed in the IVF consent form;

• Patients are not advised of selection criteria (as required by section 5.5 (i) and (ii) of the COP).

• Information does not advise patients of the statutory storage period for gametes (COP 5.4 (vi)), their options in the event of death or mental incapacity (COP 5.4 (vii)) although again, these issues are addressed in consent forms.

The centre should review the provision of information in consent forms, taking into consideration the likelihood of patients retaining copies of consent forms.

76. Information for patients providing or receiving donor gametes does not reflect that donors and recipients can consent to the exchange of non-identifying information on the outcome of treatment. This was commented on in the previous report and was the subject of a Licence Committee recommendation. The centre should revise documentation and consents and provide copies of the revised documents to the HFEA.

77. Information for patients undergoing treatment with donated gametes does

not reference the availability of non-identifying information provided by the donor. Patient information should be revised to inform patients about the non-identifying information that may be available to the recipients of donor gametes or children born as a result of treatment with donor gametes (chair’s letter CH(04)07). It is expected that patients will approach centres for this non-identifying information in the first instance (see HFEA Update Issue 5, November 2004) and the centre should ensure that they have been provided with the necessary information by suppliers of donor sperm.

78. Information provided on the centre’s website was reviewed on the day of the

inspection. It was unclear from the website which period the reported outcomes related to and the information did not correlate with outcome data submitted to the HFEA or reported in the Patient’s Guide. The data on the website should be revised to ensure accuracy and that patients are advised


of the live birth rate per treatment cycle as required by section 5.5 iv of the COP.

Record keeping procedures 79. A review of welfare of the child assessment and consent to treatment and

storage forms in 30 patient records was carried out concurrently with the renewal inspection. The records of 25 patients were correctly completed and were compatible with the treatments carried out. Omissions were seen in five sets of records and these are documented in the table below

Treatment type

Error Breach of Code reference Number of errors

ICSI Welfare of the child assessment not repeated after the birth of a child

COP section 3.5 Treatment centres are expected to repeat the welfare of the child assessment where there has been: (iii) A child born to the patient(s) since the previous assessment See paragraph 54

1

IVF Patient not provided with a copy of the 007 consent form

COP section 6.7 It is expected that a copy of the signed consent form will be provided for those who have given consent.

1

IVF No GP welfare of the child assessment in records

1990 HFEA Act Section 13 (5) A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father) and of any other child who may be affected by the birth.

1

DI/ICSI GPs providing WOC assessment reports different from those to whom patients consented to disclosure of information

COP section 12.5 Treatment centres are expected to seek each patient’s written consent for disclosure of information which relates to the provision of treatment services to them.

2

80. The PR acknowledged the omissions and agreed to ensure that appropriate

action would be taken if further treatment is offered. In the case of patients


consenting to disclosure to GPs who operate in group practices, this is a common difficulty. GPs in group practices carry out administrative procedures on behalf of colleagues and this may lead to the completion of WOC assessment reports by GPs different from those to whom patients consented to disclosure of information.

Three embryo transfer arrangements 81. Clinical protocols, patient information and consent forms have all been

revised to reflect the current regulations relating to the number of embryos that can be transferred.

Audit

Centre’s own audit of stored material 82. The centre carries out a programme of rolling audit and no inconsistencies

have been found to date although a sample previously reported as missing remains missing. The audit was due for completion in May 2005 and the centre should submit a report of the audit to the HFEA.

Spot check of tracking process for stored material 83. A spot check of four embryos and four sperm samples (two from tank to

records, two from records to tank) was carried out. All samples were tracked successfully.

HFEA register 84. A minor issue relating to the completion of HFEA treatment forms was

identified by the registry team. The leading 0 is occasionally omitted when reporting form numbers, donor numbers and the centre number on treatment forms. This was discussed with the HFEA forms co-ordinator.

Clinical governance 85. The CARE organisation has developed and implemented a corporate risk

management policy. CARE Sheffield has its own written risk management policy and staff have access to risk management training.

Risk management 86. The centre has a comprehensive system of meetings which address issues

relating to risk management within the centre and more broadly in the CARE organisation.

87. The centre carries out regular audits of outcome that are related to individual

practice. 88. The laboratory carries out a broad range of appropriate quality assurance

tests.


89. The centre has a written incident management policy and reported evidence of learning from incidents. The findings of the ALERT system are discussed at appropriate group meetings.

90. The centre reported six incidents in the time covered by this report. All of

the incidents were investigated satisfactorily.

Complaints 91. The centre has an appropriate protocol for responding to complaints and

feedback and there is separate information advising patients of the complaints procedure.

92. Ten complaints were received in the period covered by this report; all were

resolved satisfactorily. Inspection of the complaints log showed that all complaints were responded to within the statutory time period.

Breaches of the Code of Practice or Act 93. A number of breaches were observed on inspection of patient records and

these are documented in paragraph 79. 94. Patient information requires revision in order to fully comply with the

requirements of the COP and these are documented in paragraphs 55, 61 and 75 to 77.

Compliance with previous conditions and recommendations

Conditions 95. The centre has no additional conditions on its licence.

Recommendations

96. When considering the previous interim report, the Licence Committee made

three recommendations. They are listed below along with the centre’s response.

Recommendation Adopted by

centre (Y/N) Comments

1. The centre should fit low level nitrogen alarms to all its dewars and these alarms should be connected to a remote alarm system.

Y

2. The embryologists should give consideration to undertaking a basic semen analysis course.

Y


3. The centre's patient information

should be revised and updated as follows: • the egg sharing information and

consent forms for both donors and recipients do not currently state that the outcome of the donor and recipients respective treatments may be disclosed to the other party if prior consent is gained and should be updated accordingly;

• the centre should amend patient information so that patients are aware that the initial storage period for embryos may be up to five years;

• the centre should remove the word 'indefinitely' from the sentence '….the best embryos are frozen in liquid nitrogen that preserves them indefinitely;

• the egg sharing information

currently states that egg donors have to be under the age of 36 at the time of donation. This should be amended to state that no egg donor may be over the age of 35;

• the data currently available to patients (pregnancy rates April 2003 to March 2004) are slightly different to the data submitted in the application. This was due to the unfamiliarity with the new HFEA data forms;

• the information currently displays the prior address of the HFEA and should be updated to the current address.

N

N

N

N

N/A New data submitted

Y

See paragraph 76 See paragraph 75 The centre would like to be advised of the evidence that liquid nitrogen does not preserve embryos or sperm indefinitely These two statements are considered to be equivalent


Key points for the Licence Committee 97. The inspection team supports the renewal of the centre’s licence for

treatments set out in paragraph 16 above and the variation of the centre’s licence to include storage of eggs (patient and donor).

Issues 98. The inspection team would like to draw the following points to the attention

of the Licence Committee . • Patient information is largely clear and comprehensive but a number of

minor omissions were noted on evaluation of the documentation. Subsequent to the inspection, the centre agreed to review the patient information in relation to the omissions described in paragraphs 55, 60, and 75 to 78.

• The centre wishes to be licensed for storage of eggs (patient and donor). The centre submitted appropriate patient information on egg freezing and laboratory protocols for the procedure. The Licence Committee is asked to consider varying the centre’s licence to include this treatment (see paragraph 16).


Appendix A The inspection team and staff interviewed

The inspection team List the inspectors in alphabetical order. If you include a title for one person ensure you include it for all to maintain consistency. Catherine Grieve Social and ethical advisor David Gibbons Scientific advisor Debra Bloor Chair, Inspector, HFEA Sandy Mather Head of Inspection, HFEA, observer Yacoub Khalaf Clinical advisor

Centre staff interviewed Elizabeth Lenton Person responsible Five members of the centre’s staff also took part in meetings with the inspection team.

Conflicts of interest None declared.

Documents

CARE at The Sheffield Fertility Centre (0061)