Cromwell IVF and Fertility Centre, Darlington (0075)

Transcription

1 Human Fertilisation and Embryology Authority Report of a renewal inspection at Cromwell IVF and Fertility Centre, Darlington (0075) October

2 Contents Key facts about the centre... 3 Summary... 4 Background to inspection... 5 The centre s context... 5 Type of work carried out... 5 Staff... 6 The premises, equipment and other facilities... 8 Clinical, nursing and laboratory procedures Procedures for assessing clients and for assessing and screening donors Counselling process and facilities Patient experience Record keeping procedures Data analysis Audit Clinical governance Breaches of the Code of Practice or Act Compliance with previous conditions and recommendations Key points for the Licence Committee Appendix A The inspection team and staff interviewed Appendix B Sources of evidence

3 Key facts about the centre Centre name Cromwell IVF and Fertility Centre, Darlington Centre address Woodlands Hospital Morton Park Darlington Durham DL1 4PL Centre number 0075 Person responsible Kamal Ahuja Nominal licensee Eric Simons Activities of centre 2003/04 Licensed treatment cycles Donor Insemination Research Storage IVF ICSI FET Egg Sharing Other None Yes Focus of inspection General inspection to review the centre s licence. Additional licence None conditions Licence expires 31 March

4 Summary 1. The centre has been licensed since 1992 but has only been based in its current premises since early The centre offers licensed treatment to private patients in Darlington and the surrounding area. The centre has a large egg sharing programme with satellite links with the Cromwell centre in London (0074). 2. The centre is currently licensed to undertake Donor Insemination (DI), In Vitro Fertilisation (IVF), IVF with donor eggs, IVF with donor sperm. IVF with egg sharing, Intra Cytoplasmic Sperm Injection (ICSI), ICSI with donor sperm, Gamete Intra Fallopian Transfer (GIFT), GIFT with donor sperm, GIFT with donor eggs, storage of sperm, storage of embryos, storage of eggs, assisted hatching (mechanical) and storage of sperm within testicular tissue until 31 March 2005 with no additional conditions on the licence. 3. This was a renewal inspection and focused on all aspects of the centre s services. The treatment data analysed (375 cycles) were from the period 31 July 2003 to 31 July The inspection team made recommendations regarding the following areas Deceased Fathers Act Registration of embryologists Consents in patient records Laboratory and welfare of the child protocols Patient information 5. Since the inspection the centre has addressed several of these areas and has supplied satisfactory information and/or documentation. 6. A previous Licence Committee made two recommendations, both of which have been complied with. 7. The inspection team recommends that the licence be renewed for 36 months. 4

5 Background to inspection 8. This was a renewal inspection and focused on all aspects of the centre s services. The treatment data analysed were from the period 31 July 2003 to 31 July One site visit occurred on 21 October 2004 which lasted six hours. The most recent HFEA audit visit took place on 16 January The report was reviewed by the centre in November The centre s context 11. The centre has been licensed since 1992 but has only been based in its current premises since early Licensed treatment is offered to private patients in Darlington and the surrounding area. The centre has a large egg sharing programme (131 cycles Aug 2003 Jul 2004). 12. The centre is currently in discussion with the local Primary Care Trust (PCT) regarding the National Institute for Clinical Excellence (NICE) guidelines and NHS contracts. 13. The centre is open from 9am to 4pm Monday to Friday with counselling sessions held on Thursday afternoons. The average waiting list is around 6 to 12 weeks for a consultation. Type of work carried out Licensed treatment 14. The centre carries out the following licensed treatments Donor Insemination (DI) In Vitro Fertilisation (IVF) IVF with donor eggs IVF with donor sperm IVF with egg sharing Intra Cytoplasmic Sperm Injection (ICSI) ICSI with donor sperm Gamete Intra Fallopian Transfer (GIFT) GIFT with donor sperm GIFT with donor eggs Storage of sperm Storage of embryos Storage of eggs Assisted hatching (mechanical) Storage of sperm within testicular tissue 5

6 Satellite arrangements 15. The centre has a satellite arrangement with the Cromwell IVF centre in London (0074). Staff 16. All of the embryology staff have been at the centre less than a year, with the exception of one of the senior embryologists who is currently on maternity leave. The Person Responsible and Nominal Licensee are both based in the London Cromwell centre (0074) but visit the centre for meetings. The Accredited Consultant at the centre has been based at the centre for around two years. The majority of nursing staff have joined the centre since the last inspection in The centre can use other embryologists from the Cromwell group to cover periods of annual leave or sickness. 18. Previous concern over whether the consultant based at the centre was suitably qualified to have clinical responsibility has been resolved. The centre plans to apply in the New Year to change the Person Responsible to a consultant who is permanently based at the centre. Staffing profile Person responsible Kamal Ahuja Nominal licensee Eric Simons Accredited consultant Eric Simons Other medical staff 2 (both accredited consultants) Embryologists 3 (1 senior, 1 qualified, 1 trainee) ICSI practitioners 2 Nursing staff 5 (all RGN) Independent counsellor 1 Complaints manager Kamal Ahuja 19. The majority of staff are new to the centre, the staff numbers are appropriate for the number of cycles carried out each year and the working capacity within the centre e.g. size of the laboratory. Professional registration and continuing professional development (CPD) 20. The centre currently has three embryologists (one senior, one qualified, one trainee) based in Darlington. A further senior embryologist is due to return to the centre on 1 November The embryologists are not registered with the Health Professions Council (HPC) although the applications are due to be sent off within the next month. It is important that the senior embryologist is registered otherwise the junior embryologists cannot start their training which requires to be carried out by a registered embryologist. All of the embryologists have also applied for the Association of Clinical Embryologists 6

7 (ACE) certificate. Since the inspection the centre has stated that the senior embryologist is to submit his application to the HPC on 1 November 2004 with other staff applying later in the year. 21. The centre has a budget for allowing staff to attend relevant courses and conferences where necessary. Several of the nursing staff have visited the Cromwell centre in Swansea (0059) to discuss good practice issues. 22. The centre holds regular team meetings between clinical, scientific and nursing staff to discuss potentially difficult cases. The centre should ensure that these meetings are minuted. 23. The person responsible and nominal licensee attend audit meetings held every four to six weeks. These meetings discuss recent success rates, changes to protocols and HFEA alerts. These meetings are minuted and then disseminated to all relevant staff. 7

8 The premises, equipment and other facilities Premises 24. The premises were custom built when the centre relocated to the hospital in early 2003 and are well equipped and patient friendly. Equipment 25. There has been no change to any of the centre s equipment with the exception of two new incubators. The centre has maintenance contracts for the equipment and keeps records of all maintenance and inspections carried out. Security 26. The centre is a self contained unit within the hospital. The clinical and laboratory areas are inaccessible to non-authorised personnel. The centre restricts access to areas such as the laboratory and the theatre through keypad locks. Confidentiality 27. Current patient records are kept in locked cabinets in an office. The office is locked at night and when it is unoccupied. Older records are kept in a separate locked store room. Arrangements for collecting sperm samples 28. The centre has a dedicated sperm production room. It has a lockable door, sink and chair and is comfortable and discrete. Cryostore facilities, oxygen and dewar alarms 29. The centre has four dewars which are all linked to a low nitrogen level alarm. The alarms are linked to a monitor that constantly observes the temperature of each dewar. The temperature is recorded on daily reports which the centre staff check and file. The alarms are also linked to an autodialler system which contacts the on-call embryologists if the alarms sound outside of normal working hours. The centre tops up the dewars twice a week or more frequently if necessary. 30. At the time of the site visit the centre did not have a written protocol for topping up of dewars. Since the inspection the centre has developed and submitted a protocol detailing the process. 31. The centre does not have a spare dewar in cases of emergencies and should procure one as per recent HFEA directions (CH (04)03). 32. The centre does not store any oncology samples and has screened all stored samples for HIV and Hepatitis B/C as per the relevant Chair s letter and the 6 th Code of Practice. 8

9 33. The laboratory is equipped with a suitably located low oxygen level alarm. At the time of the site visit the centre did not have a written protocol on what the procedure would be on entering the laboratory if the oxygen alarm sounded. Since the inspection the centre has developed and submitted a protocol detailing the process. Emergency facilities 34. The centre uses sedation instead of general anaesthetic for egg collection and an anaesthetic nurse is present during such procedures. There is also an emergency trolley located next to the theatre. 35. Any patient suffering from OHSS is referred to the private hospital in which the centre is based under the care of the centre consultant. 9

10 Clinical, nursing and laboratory procedures Clinical 36. The clinical protocols were considered satisfactory, with a concise protocol on the management of ovarian hyper stimulation syndrome (OHSS). 37. The majority of protocols were version controlled. The centre should ensure that all clinical protocols are version controlled. Nursing 38. All protocols relevant to nursing were considered satisfactory. The centre should ensure that all nursing protocols are version controlled. Laboratory 39. The laboratory protocols were considered satisfactory with the following exceptions The centre has a thorough dedicated witnessing protocol although the protocol for embryo freezing makes no reference to witnessing and should be amended to do so. The relevant equipment list and contact details should be updated so that the information is accurate. All laboratory protocols should be version controlled. 10

11 Procedures for assessing clients and for assessing and screening donors Welfare of the child 40. There was evidence in the patient records that the centre carries out welfare of the child assessments. However, at the time of the site visit the centre did not have a written protocol which documents all the processes as required in the 6 th Code of Practice. Since the inspection the centre has submitted a protocol which outlines how the centre addresses welfare of the child and what action is taken in each eventuality as per the requirements of the 6 th Code of Practice. 41. The centre has good relationships with the local GPs and regularly receives welfare of the child assessment reports from them. Ethics committee 42. The centre has access to an ethics committee based in London which is the same committee used by the Cromwell, London (0074) centre. The centre has not referred any Darlington based cases to the ethics committee. Assessing and screening donors 43. The centre does not recruit its own donors and buys in donor sperm from other licensed centres. 44. The centre does not contact GPs in reference to genetic screening for donors and should do so to ascertain whether or not potential patients are at risk of transmitting serious genetic disorders. Since the inspection the centre has submitted an amended checklist which contains a list of genetic illnesses and a standard request for completion by the GP. 11

12 Counselling process and facilities Counselling protocols 45. The centre should develop a protocol to distinguish between assessment of patients and counselling. The protocol should explicitly document the differences and the responsibilities of the staff involved. Counselling referral arrangements 46. The centre s independent counsellor is present in the unit on Thursday afternoons for three hours. 47. The centre offers one free session of counselling. Section 7.14 of the Code of Practice states Where a woman is in the process of undergoing fertility treatment and the question of treatment with donated gametes or embryos derived from them arises, it is expected that donation implication counselling will be offered separately from treatment implications counselling. The centre was advised to re-examine its policy of one free counselling session for couples having treatment using donated gametes in light of the above. Since the inspection the centre has amended the patient information to inform patients that a second counselling session can be arranged if the patient wishes. Supervision and professional registration 48. The centre provides funding for the counsellor s continuous professional development. 49. The counsellor is a member of BICA and BACP and receives regular external supervision from a dedicated fertility counsellor supervisor although this has to be paid for by the counsellor herself. 50. The centre should ensure that the counsellor is invited to team meetings or, receives formal minutes from them. Counselling audit 51. The centre provided an audit of counselling uptake for the period July 2003 to June 2004 as shown below. The percentage uptake of counselling for the same period was 10.4%. Referrals 42 Patients seen 39 Ovum donors 22 Ovum recipients 7 Own treatment 8 Altruistic donors 2 Did not attend 3 12

13 Patients having three off more sessions 4 Patients having one off sessions 35 Patients having a couple of sessions 2 Sessions where couples attended 37 Sessions where just the woman attended 2 Location of counselling facilities 52. The centre has a dedicated counselling room which is pleasant, comfortable, and private. However, the centre acknowledged that the room requires further soundproofing to maintain patients discretion. The centre should ensure that counselling sessions within the room remain confidential. 13

14 Patient experience Patient feedback 53. There is currently no patient support group although the centre hopes to initiate one in the near future depending on demand. 54. The centre retains any patient feedback to inform potential changes about the service. Patient information 55. The patient information was reviewed and the following points were fed back to the centre there is no mention of the risks of multiple births in the patient information for blastocyst transfers and mechanical assisted hatching no reference is made to the change in embryo transfer policy as specified in the 6 th Code of practice. The patient information should be updated to reflect this there is a disparity between the protocol and patient information as to whether the patient can eat prior to egg collection and this should be amended there is a disparity between the protocol and the patient information as to whether the patient should wash with soap prior to sperm production and this should be amended the information on sperm cryopreservation does not make reference to the statutory storage limits and should be amended the centre s information on egg sharing is concise and detailed but does not mention that known egg sharing is possible and should be amended to reflect this the egg sharing information and consent form should be amended to state that with appropriate consent the donor and recipient may be told of each others treatment outcome. the information does not make reference to the recent changes in donor anonymity and should be amended to reflect the changes some references to the Code of Practice in the patient information still refer to the 5 th Code of Practice and should be updated to the 6 th Edition although the majority of the patient information is version controlled, the centre should ensure that this practice is consistent throughout. 14

15 56. Since the inspection the centre has amended the patient information in light of the comments above and submitted satisfactory documentation. Record keeping procedures 57. The inspection team examined 25 patient records that covered a range of treatments offered by the centre. Treatment type Error Breach of Code reference Number of errors Various No evidence of GP welfare 13(5) HFE Act 2 of the child assessment carried out th Code of Practice Various No consent to disclosure 33 HFE Act 3 Various (96)8 forms missing when storage of embryos has been extended 2(2) Statutory storage period for embryos 2 Various Inconsistent or implausible wishes after death in the (00)6 & 7 forms Various Patient copies of (00)6 & 7 forms in records IVF Consent to treatment form not signed IVF (00)7 form for donated eggs not present in egg share records 1996 N/A 12 N/A th Code of Practice th Code of Practice 58. The inspection team discussed the findings of the patient record audit with the centre. The centre has a checklist to ensure that all relevant documentation is present and signed prior to commencement of treatment. However, in the records examined it had rarely been used. 59. The centre should have a training session to ensure that all forms are present, correctly completed and signed. 60. Since the inspection the centre has allocated a fertility nurse whose responsibility it will be ensure all consents are present, accurate and complete prior to commencement of treatment. Other staff will be trained to cover for absence. 61. The centre has also begun a further review of all the records of patients who have been treated at the Darlington centre (approximately 350 records). 62. The centre should amend the consent forms regarding parental responsibility to take into account the recent changes in legislation involving

16 unmarried couples. Since the inspection the centre has addressed this and has supplied satisfactory documentation. 63. If the centre gains consent to disclosure from the patient then the centre does not have to pass on correspondence via the patient. This is implied in a statement in the centre s standard correspondence with the GPs and should be removed. Since the inspection the centre has addressed this and has supplied satisfactory documentation. Data analysis 64. The table below shows the IVF/ICSI success rates for the period July 2003 to June Period July December 2003 January June 2004 Number of embryo transfers (fresh and frozen) Clinical pregnancies Success rate (%) 65. The centre has attributed the increase in success rates to a change in protocol as introduced by the senior embryologist upon arrival. The centre has changed the fertilisation check protocol to a scoring system of nucleoli size, number and their alignment to the pronuclie junction. This system is used to select the most suitable embryo/s for transfer. 66. Embryo transfer is also restricted to two clinicians to maintain consistency and monitoring of results and technique. 67. The centre should resubmit the data after amending the errors in calculation and presentation which were highlighted by the inspection team. Three embryo transfer arrangements 68. The centre has undertaken five, three-embryo transfers in the period July 2003 to July All of these transfers took place prior to the change in embryo transfer policy introduced with the 6 th Code or Practice in March It is not the centre s policy to transfer more than two embryos and the centre often refers patients to the Code of Practice if they request a three embryo transfer. 16

17 Audit Centre s own audit of stored material 69. The centre has conducted an audit of stored material within the last year. No discrepancies were noted and all documentation relating to storage was correct. The centre did not submit a report of the audit and one should be forwarded to the HFEA. Since the inspection the centre has supplied a copy of the audit which was satisfactory. Spot check of tracking process for stored material 70. The following audit trails were observed and no errors in location or patient identification were noted. Embryos Two samples tracked from record to dewar, and two samples tracked from dewar to record Sperm Two samples tracked from record to dewar, and two samples tracked from dewar to record 17

18 Clinical governance 71. The centre has its own clinical governance policies as it is a self contained unit within the hospital but also abides by the general clinical governance polices of the hospital. Risk management 72. The centre has audit meetings every four to six weeks where recent HFEA alerts are discussed and any relevant changes made to protocols. 73. All HFEA alerts are disseminated to relevant staff as are the minutes of the audit meetings. 74. The centre has had one incident recently where an incubator malfunctioned resulting in a cancellation of a patient s cycle as other arrangements could not be made. Following the incident the centre procured two new incubators and has installed equipment to prevent a similar malfunction reoccurring. Complaints 75. The centre recorded two complaints since the last inspection, both of which have been resolved. 76. Copies of complaints are fed back to the hospital clinical governance meetings. A representative from the centre will be in attendance. Other matters 77. The centre has produced patient information and consent forms regarding the Deceased Fathers Act which are concise and clear. The centre has not been informing current patients or contacting retrospective patients with regards to the implications of that Act. The centre was asked to address this as a matter of urgency. Since the inspection the centre has begun informing all current patients of the implications and will contact all the retrospective patients with samples in storage in due course. 78. Due to the financial policies of the Cromwell group, the centre is consistently overdue with payment of HFEA fees. The centre agreed to restructure its payment policy so that it meets HFEA deadlines. 18

19 Breaches of the Code of Practice or Act 79. See patient records audit; paragraph 57 19

20 Compliance with previous conditions and recommendations Conditions 80. The centre has no conditions on its current licence. Recommendations 81. The licence committee made two previous recommendations. They are listed below. Recommendation The centre should use the amended welfare of the child forms without exception The centre should carry out a review of consent forms held within patient notes Adopted by centre (Y/N) Y Y Comment There was consistent use of the same form in all records examined since the last inspection The centre has completed a review but should continue to review in light of the recent patient records audit 20

21 Key points for the Licence Committee 82. The inspection team supports the renewal of the centre s licence for treatments set out in paragraph 14 above. Issues 83. The inspection team would like to draw the following points to the attention of the licence committee. The centre should ensure that all team meetings are minuted, the counsellor is invited to attend and that the minutes are disseminated to all members of staff. The centre should ensure all protocols are consistently version controlled and the changes noted in paragraph 39 are adopted. The centre should develop a protocol to distinguish between assessment of patients and counselling. The protocol should explicitly document the distinction between the responsibilities of the staff involved. The centre should attempt to further soundproof the counselling room to maintain patient confidentiality. The centre should complete the review of all patient records and ensure that all relevant consents and documentation are present and complete prior to commencement of treatment. The centre should continue to inform all current patients regarding the Deceased Fathers Act. All retrospective patients with samples in storage should also be contacted. 21

22 Appendix A The inspection team and staff interviewed The inspection team Ruth Curson Michael Loveridge Stephen Lynch Avril MacLennan Jim Monach Imogen Swann Clinical inspector Regulatory officer Scientific inspector Chair, Senior regulatory manager, HFEA Social and ethical inspector Observer, Senior regulatory manager, HFEA Centre staff attending meetings with the inspection team Dima Abdo Kamal Ahuja Matey Andanov Claire England Natasha Fragkogianni Julian Mamiso Janet Owen Eric Simons Conflicts of interest None declared. Trainee embryologist Person responsible Senior embryologist Nurse coordinator Embryologist Consultant Gynaecologist Counsellor Nominal licensee 22

23 Appendix B Sources of evidence 1. Previous licence committee minutes 2. Previous inspection reports 3. Relevant correspondence between the centre and HFEA 4. Application form 5. Staff CVs 6. Outcome data from licensed treatments 7. Patient information 8. Consent forms 9. Treatment forms 10. Standard operating procedures and protocols 11. Interviews with centre staff 23