interim inspection report - microsoft · 2016. 12. 30. · competency assessment of the lead...

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Date of Inspection: 28 January 2010 Length of inspection: 6 hours Inspectors: Andy Leonard; Janet Kirkland Inspection details: This report covers the pre-inspection analysis, the visit and information received from the centre between 1January 2009 and 28 January 2010. Date of Executive Licensing Panel: 21 April 2010 Purpose of the Inspection report The purpose of the inspection is to assess a centre’s compliance with the HF&E Act 1990 (as amended), the HF&E Act 2008 and the HFEA Code of Practice, 8th edition (CoP) to ensure that centres are providing a quality service for patients. The report summarises the findings of the interim 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 Authority’s Executive Licensing Panel which makes the decision about the continuation of the centre’s licence. Centre details Centre Name ACU Queen Mary’s Hospital, London Centre Number 0270 Licence Number E0270/2/b Centre Address

Assisted Conception Unit, Queen Mary’s Hospital, Roehampton Lane, SW15 5PN

Telephone Number 0208 4876417 Person Responsible Rowena Bevan Licence Holder None Date Licence issued 1st October 2009 Licence expiry date 30th June 2012 Additional conditions applied to this licence

None

Interim Inspection Report

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Contents

Page

Centre details ......................................................................................................................... 1 Contents ................................................................................................................................. 2 Report to Executive Licensing Panel ................................................................................... 3

Recommendation to the Executive Licensing Panel ........................................................ 3

Details of Inspection findings............................................................................................... 4

Brief description of the centre and its licensing history .................................................... 4 Activities of the Centre..................................................................................................... 4 Updated actions since the centre was inspected ............................................................. 5 Focus of inspections for 2010-12..................................................................................... 7 Changes/improvements since the inspection on 28th February 2008 ............................ 11 Areas of concern............................................................................................................ 15

Areas of practice that require the attention of the Person Responsible

Critical area of non compliance...................................................................................... 25 Major area of non compliance........................................................................................ 26 Other area of practice that requires consideration ......................................................... 37

Additional information provided by the Person Responsible.......................................... 40

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Report to Executive Licensing Panel Recommendation to the Executive Licensing Panel: With regard to overall compliance, the inspectorate considers that it has sufficient information drawn from documentation submitted by the centre prior to the inspection and from observations and interviews conducted during the inspection to conclude that: • The Person Responsible (PR) is considered by the inspectorate to have discharged her

duties under S.17 of the HF&E Act 1990 (as amended). It was however noted during this inspection that two issues from the last inspection remained to be addressed (validation and competency assessment).

• Premises, processes and procedures used in the conduct of licensed activities are largely

suitable. Improvements were recommended and the centre has already taken action in some areas such that on 31 March 2010, the remaining regulatory issues concerned: • Air quality monitoring • Staff induction, training and competency assessment • The audit of procedures against the regulatory requirements • Validation of key processes and equipment • Review of the quality management system • The use of disposables which comply with centre requirements

The PR has plans to address these issues within appropriate timeframes. The inspectorate will monitor the implementation of these plans The inspectorate recommends the continuation of the centre’s licence without additional conditions and that the Executive Licensing Panel requires that the PR to comply with the recommendations detailed in this report within the prescribed timeframes.

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Details of Inspection findings Brief description of the centre and its licensing history: Following a self assessment which was presented to Licence Committee on 3rd May 2007 the centre was granted a one year licence to perform intrauterine insemination (IUI) treatments. The centre was then inspected on 28th February 2008 for licence renewal and the report was presented to Licence Committee on the 5th June 2008. The Committee renewed the centre’s licence for 4 years with no additional conditions, though noted several regulatory issues. The renewed licence is active from 1st July 2008 – 30th June 2012. The centre currently provides approximately 15 - 25 IUI treatments per year for patients funded by the National Health Service (NHS) or who are privately funded. The centre also provides a transport in vitro fertilisation (IVF) service for approximately 450 patients per year under a third party agreement with The Bridge Centre (HFEA centre number 0070), where the embryology culture is performed and embryo transfers take place. The PR is a consultant obstetrician and gynaecologist and a member of the Royal College of Obstetricians and Gynaecologists. The PR has completed the HFEA PR Entry Programme. Activities of the Centre in the year 1 January – 31 December 2008: Licensed treatment cycles1 IUI only, 43 cycles reported on HFEA website Donor insemination n/a Unlicensed treatments Clomiphene cycle monitoring Research n/a Storage n/a *These data were provided by the centre for the period indicated above. The data for 2009 will be submitted to HFEA by 28 February 2010 and will be published on the HFEA website soon thereafter.

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Updated actions since the centre was inspected on 28 January 2010, as of 31 March 2010: No further action required The PR’s response in this report and information provided by the PR after the inspection indicate that actions have been taken to bring the centre’s practices into compliance with regard to the following issues: • Area of practice 1

Non-contemporaneous witnessing: previously non-compliant with T71 • Area of practice 2

Labelling of gamete containers: previously non-compliant with CoP Guidance 18.20 • Area of practice 3

Recording of witnessing: previously non-compliant with CoP Guidance 18.7 • Area of practice 6

Responsibilities of the PR, as defined by HF&E Act (1990) as amended, Section 17, paragraphs 1(b),1(d),1(e)

• Area of practice 9 Quality indicator monitoring: previously non-compliant with T35

• Area of practice 13 Logging of equipment cleaning: previously non-compliant with T26

• Area of practice A Annual review of risk assessments is now scheduled

• Area of practice B Annual review of documents is now scheduled: previously non-compliant with CoP Guidance 31.6

Further action required The centre has developed appropriate action plans to bring its practices into compliance with regard to the following issues. These action plans have yet to be completed thus the centre’s practices remain non-compliant in these areas: • Area of practice 4

The compliance of air quality with T20 and the validation of the air monitoring protocol: non-compliant with T72. Plans to ensure the collection of appropriate data supporting air quality compliance with T20 are in place (completion 31 May 2010). The PR must also ensure the air quality monitoring protocol is validated, compliant with T72, by 31 May 2010 and should advise the Executive when this is completed.

• Area of practice 5

Competency assessment of the Lead Scientist: non-compliant with T12 and T15a. A plan for this has been developed by the PR and will be implemented by 30 April 2010. The Executive should be informed when this has been completed


Staff induction protocols with initial competency assessment programmes: non-compliant

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with T12 and T15a. The PR plans to develop these protocols by 30 April 2010. The Executive should be provided these induction and competency assessment protocols when they are completed.


Protocols for on-going competency assessment: non-compliant with T12 and T15a. The PR has supplied competency assessment certificates for insemination and for transvaginal ultrasound. The PR also needs however to develop by 30 April 2010 protocols which describe key competencies tested for each staff group and the testing frequencies. The Executive should be provided with these protocols when they are completed.


Audit of procedures against regulatory requirements: non-compliant with T36. The PR plans a rolling audit of compliance of procedures in 6 main areas of practice, 3 to be completed annually. The areas of practice highlighted will be audited for compliance by 31 May 2010. The Executive should be advised when these audits have been completed.


Validation of key processes: non-compliant with T72. The PR plans to complete validation of key processes by 31 May 2010. The Executive notes that air quality monitoring must be included in the validation of processes and the Executive advised when the validation of key processes has been completed and which processes were validated.


Quality management system review: non-compliant with HF&E Act (1990) (as amended) Schedule 3A, paragraph 10. The PR plans to hold the review in May 2010 and annually thereafter to comply with HF&E Act requirements.


Use of a type of tube which was not CE marked: non-compliant with T31. The tube is in common use in the sector however the PR will liaise with another HFEA licensed centre to investigate batch testing of the tubes. Actions should be taken to close this non-compliance with T31 as soon as practicable and definitely by 30 April 2010 and advised to the Executive.


Validation of equipment: non-compliant with T24. The PR plans to complete equipment validate by 30 April 2010 which is acceptable to the Executive. The Executive should be advised when this has occurred.

• Area of practice C

Procedure for responding to requests for access to patient records, and providing such access: non- compliant with T44. The PR plans to document a procedure by 30 April 2010.

There were no issues in ‘Areas of Practice that require the attention of the PR’, for which the PR has not developed an action plan to bring the centre to compliance. All regulatory issues have been, or will be, addressed within time frames considered reasonable by the Executive.

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1. Focus of inspections for 2010-12 Witnessing Evidence of how the centre demonstrates compliance with Guidance Note 18 of the CoP, including the requirement to double check the identification of samples and the patients or donors to whom they relate at all critical points of the clinical and laboratory process. The centre has a witnessing protocol and IUI witnessing document which require witnessing during sperm procurement, processing and insemination at all points required by CoP guidance note 18. The centre has also audited the witnessing procedure against CoP guidance note 18. At the last inspection it was noted that witnessing of sperm preparation was non-contemporaneous. The centre was asked to risk assess this departure from CoP guidance. On this inspection, the risk assessment was provided to the inspectorate and the situation discussed with the Lead Scientist. Only one sample is processed in the air flow cabinet at a time and a further sample will not be processed until the first sample has been used for insemination. This is stated in the sperm processing procedure. Furthermore ‘99% of the time’ only one sample is processed for insemination in a day, since the centre only performed approximately 15 cycles of IUI in 2009 and 43 in 2008. The risks and control measures were documented in the witnessing risk assessment. Staff are trained and competency assessed to perform effective witnessing at induction and at what the PR judges to be appropriate intervals thereafter. Witnessing compliance will be a scheduled audit in 2010. The Lead Scientist stated that his common practice is to ensure all witnessing signatures are in place just before a sample is used for insemination. This routine check is however not documented. The records of all patients are stored on the centre’s computer system. These include photographs of the patient couple, the identity of whom is confirmed with a photographic means of identification at the first consultation. The identity of patients is confirmed at subsequent consultations and at sperm procurement by comparison of the patient(s) with photographs in the patient’s records. The evidence of compliance discussed above is also relevant to the transport IVF patients treated at the centre. There is a defined procedure in place for witnessing at egg collection and the PR has ensured that the patient information database is accessible in the treatment room to allow effective confirmation of patient identity. What the centre does well. Photographic records of patients are held on computer to allow easy confirmation of identity What they could do better. The inspectorate note that the centre’s witnessing remains non-contemporaneous at some steps. This was observed in a patient record which detailed that the processor’s checking of

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Continued. sample labelling against patient records was performed for: specimen pot and centrifuge tubes; for the centrifuge tubes and swim up tubes; and finally for the swim up tubes and final preparation tubes. Timings indicated these checks were performed during the processing by the processor. The witness signature for all three steps was however provided non-contemporaneously by the doctor who performed the insemination, just before that procedure. The Lead Scientist said this was the general practice at the centre and that it has been risk assessed, as was required by the last inspection report. The inspectorate acknowledges a risk assessment has been performed and control measures are in place. The inspectorate also note however that contemporaneous witnessing has been a licence condition requirement (T71), rather than CoP guidance, since 1 October 2009. Indeed the centre’s witnessing procedure describes that witnessing should be completed during sample processing. The PR must therefore take actions to ensure witnessing is performed contemporaneously in a manner compliant with Licence Condition T71. Gamete sample containers are labelled with the patient’s surname and date of birth. This is potentially non-compliant with CoP guidance note 18.20, which requires that all samples should be labelled with at least the patient’s full name and a unique identifier; the date of birth is acceptable as such according to CoP guidance note 18.21. This is also an issue regarding the oocyte containers used for transport IVF patients. It is recommended that the centre ensures samples are at all times labelled in compliance with CoP guidance note 18.20; where compliance can not be achieved, any departure from it should be risk assessed. The PR is advised that compliance with licence condition T101, which states mandatory requirements for sample labelling, must be maintained if any changes in labelling are made. The centre does not have quality indicators for witnessing activities, contrary to licence condition T35. This was discussed on inspection and appropriate quality indicators and systems of audit will be developed by centre staff. Witnessing was reviewed in 4 sets of IUI patient records. Witnessing signatures were seen to have been documented. In one set of records, the time of witnessing had not been noted, contrary to CoP guidance note 18.7. The centre should ensure that witnessed procedures are timed, as well as signed and dated at all times. Parenthood Evidence of how the centre demonstrates compliance with Guidance Note 6 of the Code of Practice in relation to legal parenthood: Not required for licence E0270/2/b which covers this IUI clinic In relation to patients requiring licensed treatment with donor sperm or eggs, they are referred directly to the third party clinic (centre 0070) for information provision, consenting, counselling etc, as well as the actual treatment. They are not treated as transport IVF patients at centre 0270. Thus the changes in parenthood legislation do not impact on the transport IVF patients processed by centre 0270. What the centre does well: Nothing noted at inspection What they could do better. Nothing noted at inspection

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Patient consent to the disclosure of information, held on the HFEA Register, for use in Research Evidence that the centre provides information to patients about the disclosure of identifying information, held on the HFEA Register, for use in research. (Guidance Note 5, section 5.26 of the Code of Practice) Not required for licence E0270/2/b which covers this IUI clinic In relation to transport IVF patients, centre 0270 assists the patients in completing the HFEA MT and WT consent forms which allow patients to consent to, amongst other things, the disclosure of their registry data to researchers. Staff at centre 0270 use information provided by their third party treatment service provider to inform patients about this issue before consents are collected. What the centre does well: Nothing noted at inspection What they could do better. Nothing noted at inspection Information about the cost of treatment Evidence of how the centre demonstrates that it has introduced personalised costed treatment plans for all patients in compliance with Guidance Note 4, section 4.3 of the Code of Practice. Both self funding and NHS funded patients are provided with IUI services at the centre. Self funded patients are provided with a printed costed treatment plan at the initial consultation and a copy is kept in the patient record. Self funding patients undergoing transport IVF are provided with costed treatment plans in the same manner. What the centre does well: The costed treatment plan contains an approximation of the drug costs, derived from the average costs of drugs provided to patients at centre 0270 in the treatment candidates age group. The computerised system for producing costed treatment plans was demonstrated by the Lead Scientist and was considered by the inspectorate to perform the task effectively. It is integrated with the patient information management system which holds patient records in a computer database, on a secure server which is backed up daily. What they could do better. Nothing noted at inspection.

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Consent issues in relation to the storage of embryos (including cooling off period) Evidence of how the centre demonstrates compliance with Schedule 3 of the Human Fertilisation and Embryology Act 1990 (as amended) and Guidance Note 5 of the Code of Practice relating to the withdrawal of consent to storage of embryos intended for use in treatment: Not required for licence E0270/2/b which covers this IUI clinic. For transport IVF patients, information and consenting regarding embryo and gamete storage is provided by the third party provider of IVF services. What the centre does well: Nothing noted at inspection What they could do better. Nothing noted at inspection Multiple Births Evidence of how the centre demonstrates compliance with Guidance Note 7 of the Code of Practice in relation to multiple births: Not required for licence E0270/2/b which covers this IUI clinic Multiple birth minimisation is discussed with those patients undergoing transport IVF and treatment at centre 0070. This utilises patient information produced by that centre. Centre 0070 is also responsible for monitoring and auditing multiple births, and subsequent review and revision of the multiple birth minimisation strategy. What the centre does well: Nothing noted at inspection What they could do better. Nothing noted at inspection

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2. Changes/improvements since the inspection on 28th February 2008 Area of practice Action required Observations on this inspection 1) A quality policy in line with S.4.2.1, S.4.2.3, S.5.2.2 and S.5.2.4 is not yet in place.

A quality policy should be established

A quality policy is now in place and was observed on inspection

Area of practice Action required Observations on this inspection 2) Centre management has not yet established documented quality objectives, including those needed to meet the needs and requirements of the users that are measurable and consistent with the quality policy. This is a requirement of S.4.2.4, S.4.2.1 and S.5.2.2

Quality objectives to be established.

An audit programme has been established which last year investigated Welfare of the Child, 3 embryo transfers, traceability and counselling provision. In 2010 the programme will review witnessing, procedures and the provision of information. The centre is included in the quarterly quality management review for women’s health which is submitted to the hospital board As detailed in areas of concern-5, in some areas quality indicators and their audit have yet to be established, as have quality objectives related to those quality indicators. In a broader sense the centre has established the quality objective of providing patients with services of a high standard which incorporates clinical and scientific best practice

Area of practice Action required Observations on this inspection 3) The centre does not have an established programme of risk assessment. Licence condition A.10.4 requires that risks inherent in the use and handling of biological material are identified and minimised, consistent with maintaining adequate quality and safety for the intended purpose of the gametes or embryos. The risks include those relating in

The centre team to begin risk assessing elements of their practice including witnessing.

The centre has identified processes and procedures which carry significant risk. Documented risk assessments for them have been performed. These were available for inspection and appeared to be of suitable rigour to accomplish effective risk management. The inspectorate recommend that these risk assessments are reviewed annually and further risk assessments are performed if procedures change.

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3) Continued particular to the procedures, environment, and staff health status, specific to the Centre concerned.

Area of practice Action required Observations on this inspection 4) Critical equipment and processes have not been identified or validated. This is a requirement of licence conditions A.10.13 and A.11.11, and standards S.7.8.3 and S.6.4.2.

Critical equipment and processes to be identified and validated.

Validation of key processes and equipment has not been completed, contrary to licence conditions T72 and T24, respectively. This is discussed in areas of concern-8 and -13. The scope and methods to achieve validation were discussed on inspection, as well as the requirements to do so.

Area of practice Action required Observations on this inspection 5) Air quality in the flow hood and background air quality in the environment in which gametes are processed has not been measured in a way that allows compliance with standard licence conditions to be demonstrated.

In compliance with A.10.19 it must be demonstrated that gametes are processed in an environment of at least Grade C air quality with a background environment of at least Grade D air quality.

Air quality assessment in the laboratory background is performed half-yearly according to the monitoring protocol, which has been validated by the third party air testing company. Recent particle counting results were provided which indicate that the background air achieves ISO 14644 Class 8, which approximates HFEA specified Grade D. Results were also available which indicated that the air flow cabinet providing the critical work area is serviced and tested half-yearly, and at the last test was compliant with BS EN 12469. The inspectorate considers the centre has made efforts to comply with this requirement however they have some concerns and compliance with licence condition T20 is unclear. BS EN 12469 is a recognised standard governing the location, safety, performance and testing of micro-

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5) Continued

biological safety cabinets. It was unclear from the test data whether the air quality in the critical work area complies with HFEA requirements. This was because the efficiency of the cabinet’s HEPA filters had been assessed, but no particle count or settle plate test data was in the report. Thus an assessment of air quality against HFEA requirements could not be made. Regarding the background air, ISO Class 8 approximates, but is less rigorous than, HFEA Grade D, especially regarding >5 micron particles. The PR and Lead Scientist should ensure the air quality monitoring protocol is fully validated such that it will determine compliance of the air quality with HFEA requirements, as defined in the current European Guide to Good Manufacturing Practice (GMP_ Annex 1 and Directive 2003/94/EC). This will enable the centre to ensure themselves and the HFEA, that they are compliant with licence condition T20

Area of practice Action required Observations on this inspection 6) There is currently no system in place to assess the competency of the quality manager (QM) as related to his role in preparing sperm samples for IUI. It is a requirement of licence condition A.10.9 that personnel in the centre must be available in sufficient number and be qualified for the tasks they perform.

The competency of personnel must be evaluated at appropriate intervals as specified in the quality system.

The Lead Scientist (who is the QM) now participates in the NEQAS scheme for sperm assessment. He has not however been formally competency assessed for sperm preparation, which in a breach of licence conditions T12 and T15a. The inspectorate recommends that the PR ensures that the Lead Scientist’s competence in sperm processing is formally assessed by an appropriately qualified person and that this is repeated at a frequency specified in the quality manual

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Area of practice Action required Observations on this inspection 7) It was noted that during sperm preparation, witnessing does not always occur contemporaneously.

Revised witnessing protocols or risk assess departures from witnessing guidance.

The centre was asked to risk assess this departure from HFEA guidance at the last inspection. The risk assessment was reviewed by the inspectorate and the situation discussed with the Lead Scientist. Only one sample is processed in the air flow cabinet at a time and the next sample is not processed until the first sample has been used. This is stated in the sperm processing procedure. Furthermore ‘99% of the time’ only one sample is processed for insemination in a day. The risks and control measures have been documented in the witnessing risk assessment, as required by the Licence Committee. The inspectorate notes however that contemporaneous witnessing is now a Licence Condition (T71) requirement, and this issue is discussed above in ‘inspection themes – witnessing’.

Area of practice Action required Observations on this inspection 8) As part of the centre’s home procurement process information needs to be gathered on the time that the sperm samples are produced – this is a requirement of S.7.7.10.

The time of production to be added to the information accompanying the sample.

Nearly all the centre’s IUI patients produce sperm at home and bring it to the centre. The centre was seen on this inspection to have processes and documentation in place to confirm and document the time of production and the identity of the provider. Patients are asked to sign to verify that the sample belongs to them. The inspectorate consider this requirement has been met

Area of practice Action required Observations on this inspection 9) The QM and PR reported that the majority of patients (around 95%) produce samples at home and bring them to the unit. Patients are asked to sign to verify that the sample belongs to them.

This process has not been risk assessed and it was recommended that this be done.

The risk assessment recommended by the last inspection report was observed on this inspection. The centre was seen to have processes and documentation in place to confirm and document the time of production and the identity of the provider. The inspectorate consider this requirement has been met

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3. Areas of concern The analysis of the centre’s self assessment questionnaire (SAQ) and the information the centre has submitted to the HFEA e.g. staff changes and the treatment cycles carried out at the centre, have identified that the following areas needed to be looked during the inspection visit to this centre. Area of concern-1 Inspection findings Assessment of whether the action taken meets

requirement or whether any further action is required The SAQ says the PR spends less than 20% whole time equivalent on the role

The PR is a consultant employed through Kingston Hospital to be the lead clinician for the ACU at Queen Mary’s Hospital Roehampton, and for one session per week at the adjacent infertility clinic. On inspection the PR stated that she spent approximately 5% of her time specifically on the PR role. In the last year the PR has visited centre 0070, which supports the transport IVF service, for liaison and academic meetings. The centre is generally compliant and well organised however evidence from inspection indicates that 2 breaches from the last inspection report have yet to be corrected (Section 2 above, items 4 and 6). This may indicate that the PR needs further time to complete the regulatory activities associated with the PR role. The PR confirmed this in discussions.

The inspectorate noted that 2 breaches of licence conditions from the last inspection report, concerning validation and competency assessment, have yet to be corrected. In addition, air quality testing is potentially non-compliant with licence conditions, and was raised as an issue in the previous report. The PR is reminded of HF&E Act (1990) as amended, Section 17, paragraphs 1(b), 1(d), 1(e), which require that the PR to secure that proper equipment and suitable practices are used, and that licence conditions are complied with, in the course of providing licence treatment. It is recommended that the PR consider whether the time allocated in her work plan to focus on PR duties is adequate considering the outstanding breaches, and the regulatory load at this licensed IUI centre which has a relatively large transport IVF workload.

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Area of concern-2 Inspection findings Assessment of whether the action taken meets requirement or whether any further action is required

The SAQ indicated that induction processes at the centre are not fully compliant.

All staff undergo a trust induction. A specific induction and training programme with competency assessment has been established for nursing staff.

To ensure compliance with licence conditions T12 and T15a, the PR should ensure that induction programmes, with training and competency assessment in key activities, are available for all staff groups at the centre and are applied to new staff.

Area of concern-3 Inspection findings Assessment of whether the action taken meets

requirement or whether any further action is required Training regarding processes and procedures, traceability, confidentiality, and data submission to HFEA, was assessed by the PR as less than fully compliant in the SAQ.

A detailed training plan was seen to be in place for nursing staff. Evidence was observed by the clinical inspector that training had been provided to nursing staff. Centre staff attend centre 0070 half yearly for academic meetings. Staff have also attended fertility conferences in the last year. Staff are expected to fulfil the continual professional development requirements for them to maintain membership of their respective professional bodies. Training support is provided where required.

A training plan outlining training in key activities associated with licensed treatment is documented for nursing staff but not for other staff groups. To be compliant with licence condition T15, training plans need to be documented for all staff groups.

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Competency assessment regarding processes and procedures, traceability and witnessing was assessed by the PR as less than fully compliant in the SAQ.

Competency assessment of six areas of important practice for nurses was seen to be performed in personnel records. The Lead Scientist partakes in the NEQAS programme for sperm assessment.

As alluded to in Section 2, item 6, competency assessment for sperm processing for the Lead Scientist needs to be developed and documented. To ensure full compliance with licence condition T15a, the competency assessment programme should also include other key activities associated with the Lead Scientist role, such as witnessing and maintaining traceability. Competency assessment programmes also need to be established for clinicians and other staff groups (except nursing) for all key activities associated with their roles, to ensure compliance with licence condition T15a.


requirement or whether any further action is required In the SAQ, the PR assessed the centre as being less than fully compliant regarding quality indicators and their audit, for information provision, consenting, Welfare of the Child assessment, procuring, processing and transporting gametes and embryos, witnessing, traceability, the quality management system, confidentiality and record keeping and document control

Quality indicators and audit were discussed with the PR and Lead Scientist. It was noted that some quality indicators are in place (e.g. sperm motility after processing) and that audits have been performed (for counselling, 3 embryo transfers for transport IVF patients, traceability, welfare of the child). The centre is developing quality indicators and audit for procedures, provision of patient information and witnessing in 2010. The PR provided evidence of clinical pregnancy and live birth rate monitoring in transport IVF patients,

Given the audits already performed, the centre still need to develop quality indicator monitoring and audit for information provision, consenting, procuring, processing and transporting gametes and embryos, witnessing, the quality management system, confidentiality and record keeping and document control. Some will be developed as part of the audit plan for 2010 (e.g. witnessing, information provision). To ensure compliance with licence condition T35, the PR should review activities at the centre and ensure that required standards of quality and safety, in the form of quality indicators for all activities authorised by the licence and other activities carried out in the course of providing treatment services that do not require a licence, are established. The activities should include those described above, though the PR may choose to include others.

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Area of concern-5 Continued

which showed results in their patients were comparable to those achieved by the third party IVF centre in their own patient set. The possibility of implementing a check in patient records at insemination (or egg collection for transport IVF patients) of proposed quality indicators for many of these activities (eg consents in place, witnessing, information provision, processing) was discussed.

The PR should also ensure that the monitoring mechanisms, audit frequencies and responsibilities for the new quality indicators developed are documented, to comply with CoP guidance 23.19 – 23.22.


requirement or whether any further action is required In the SAQ, the PR assessed the centre as being less than fully compliant regarding the audit of compliance of procedures for information provision, consenting, procuring, processing and transporting gametes and embryos, the quality management system, confidentiality and record keeping and document control, against HFEA regulatory requirements.

The QM confirmed that documented procedures for witnessing, welfare of the child and consenting have been audited for compliance with all relevant regulations since the regulatory changes of the 1 October 2009. However, other procedures have not been audited for compliance, which was of concern as some were last reviewed well before that date.

The procedures associated with information provision, procuring, processing and transporting gametes and embryos, the quality management system, maintaining patient confidentiality, and record keeping and document control, still have to be audited against HFEA regulatory requirements. This is a breach of licence condition T36. To comply with licence condition T36, the PR should have these procedures audited against HFEA regulatory requirements to ensure compliance. Non-conformities and corrective actions should be documented.

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The PR indicated in the SAQ that consents were taken on the day of treatment.

Discussions with centre staff indicated that this concern pertained to consents for ICSI taken by staff at centre 0070 during treatment of transport IVF patients. Such consents are taken infrequently and only if the quality of the sperm is unexpectedly low on the day of egg collection, when sperm is provided for fertilisation of the eggs. Patients with known low sperm quality are provided appropriate information and sign consents to ICSI well before the treatment cycle. The centre’s IUI patients are provided with appropriate information before consents are taken, and all consents are signed before the day of treatment.

This situation arises only occasionally and any regulatory concerns relate to the centre at which the consent is taken, ie centre 0070, as opposed to centre 0270. The PR is however advised to discuss the issue with the PR at centre 0070. It may be prudent to provide all transport IVF patients at centre 0270 with information regarding ICSI, so that any subsequent consents to ICSI at centre 0270 are, at least, informed with appropriate information.


requirement or whether any further action is required In the SAQ, the PR assessed the centre as being less than fully compliant regarding the validation of processes.

Validation of key processes has not been completed, contrary to licence condition T72. The scope and methods to achieve validation were discussed on inspection, as well as the requirement to do so.

To comply with licence condition T72, the PR should ensure key processes are identified and validated as soon as is reasonably practicable.

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In the SAQ, the PR assessed the centre as being less than fully compliant regarding several aspects of the quality management system (QMS), including quality indicators, audit in general and specific to the QMS, assessment of compliance of activities at centre and QMS review

Quality indicators and their audit, and the compliance with procedures, have been discussed above in ‘Areas of concern- items 5 and -6.. The QM has been on a certified training course regarding quality management. The PR and QM reported that a review of the centre’s quality management system has not been held yet, but one is planned in May 2010. They also stated that the centre is included in the quarterly quality management review for women’s health which is submitted to the hospital board. Some documents in the QMS were, according to their document control footers, last reviewed more than a year before the inspection (eg the confidentiality procedure and IUI information pack).

The inspectorate welcomes the scheduling in May 2010 of a quality management review focussed on the centre. This must be carried out to ensure compliance with HF&E Act (1990) (as amended) Schedule 3A, paragraph 10. This paragraph effectively brings into UK law European Tissue and Cells Directive 2006/86/EC, Annex I part F of which requires a QMS to be operated with regular reviews. The QM and PR should ensure that the QMS review is carried out in compliance with CoP guidance note 23.12 – 23.15. The QM is reminded of CoP guidance note 31.6 (‘Documents should be reviewed, revised and reapproved at a frequency that ensures they remain fit for purpose. The maximum interval between reviews should be 12 months). The QM should review documents within the QMS for compliance with the guidance and take action to correct non-compliance.

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requirement or whether any further action is required In the SAQ, the PR assessed the centre as being less than fully compliant regarding the maintenance of cleaning records within the centre premises

This was discussed with the PR and Lead Scientist. Cleaning in the centre premises is provided by a contractor to the hospital. It was realised by the PR that cleaning is recorded by the contractor and that she could obtain attendance records for the cleaners if required. The cleaners are also cleaning to a defined protocol. Monthly spot checks of the quality of cleaning are made and documented. The Lead Scientist additionally deep cleans the laboratory himself at intervals. These deep cleans are not logged, contrary to licence condition T26. On the tour of the premises, the inspectorate considered the premises to appear appropriately clean and tidy for the centre’s activities.

The Lead Scientist should document when deep cleans in the laboratory are performed, including what equipment is cleaned, to ensure compliance with licence condition T26

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requirement or whether any further action is required In the SAQ, the PR assessed the centre as being less than fully compliant regarding the maintaining of cleaning records for equipment.

On inspection it was observed that a log of the weekly cleaning of the air flow cabinet was maintained. However, equipment cleaned as part of the laboratory deep cleaning is not recorded

The Lead Scientist should document when deep cleans in the laboratory are performed, including what equipment is cleaned, to ensure compliance with licence condition T26.


requirement or whether any further action is required In the SAQ, the PR assessed the centre as being less than fully compliant regarding the use of appropriate consumables e.g. CE certified.

On inspection, it was seen that all disposables are CE marked except one type of tube from a US manufacturer. This is potentially contrary to licence condition T31. These tubes have also not been sperm motility tested.

The Lead Scientist should ensure that all disposables comply with the centre’s documented requirements and specifications for materials used in the centre’s activities, as required by licence condition T31. Most centres would require that the tubes in question should be sourced from a supplier who can provide CE certified versions, or the versions currently in use should be sperm motility tested by batch to ensure they are fit for purpose.


requirement or whether any further action is required In the SAQ, the PR assessed the centre as being less than fully compliant regarding the validation of equipment.

Validation of key equipment has not been completed, contrary to licence condition T24. The scope and methods to achieve validation were discussed on inspection, as well as the requirement to do so.

To comply with licence condition T24, the PR should ensure key equipment items are identified and validated as soon as is reasonably practicable.

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It was observed on this inspection that traceability data for sperm pots is not collected, contrary to licence condition T99

As left To comply with licence condition T99, the PR should ensure traceability data regarding sperm collection pots is collected and stored for the appropriate time. The traceability procedure should be amended to include this.


requirement or whether any further action is required The PR stated in the SAQ that a procedure was in place for adverse incidents. This was reviewed on inspection.

The centre has a compliant procedure in place for responding to adverse incidents. Incidents concerning the centre’s IUI activities are reported by the PR to the HFEA. Incidents regarding the centre’s functioning as a satellite in transport IVF are reported to centre 0070, which is responsible for reporting to the HFEA.

The centre was considered compliant with regard to incident reporting.


requirement or whether any further action is required In the SAQ, the PR assessed the centre as being less than fully compliant regarding the presence of a procedure for control of confidential documents, including measures for establishing/maintaining data security and accuracy, resolving

The centre has a documented confidentiality procedure which was considered by the inspectorate to be, in general, compliant with CoP requirements. Patient information is all held in an electronic database, enhancing security and traceability. Paper copies are destroyed as per the

Existing procedures and practices related to maintaining confidentiality were considered by the inspectorate to be compliant with CoP requirements. The only problem noted was that the centre did not appear to have a procedure in place for responding to requests for access to patient records, and providing such access, in a manner compliant with licence condition T44. The PR should review the requirements of T44 and ensure that a protocol is either

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Area of concern-16 Continued discrepancies, preventing unauthorised disclosure, traceability, responding to requests for access, providing authorised access to confidential records, and accessibility of confidential records to unauthorised personnel

hospital’s disposal of sensitive information procedure. The database is accessed from computers around the centre which are operator password secured and backed up to a secure server. Physical security at the centre was appropriate. All rooms on the day were locked unless occupied and this practice is described in the confidentiality procedure. The PR said that a mistake had been made in assigning a score of “4” to ‘accessibility of confidential records to unauthorised personnel’; it should have been scored as “1”.

in place or is written, to achieve compliance with licence condition T44.

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Areas of practice that require the attention of the Person Responsible The section sets out matters which the Inspection Team considers may constitute areas of non compliance. These have been classified into critical, major and others. Each area of non-compliance is referenced to the relevant sections of the Acts, Regulations, Standard Licence Conditions, Directions or the Code of Practice, and the recommended improvement actions require are given as well as the timescales in which these improvements should be carried out.

� Critical area of non compliance A critical are of non compliance is an area of practice which poses a significant direct risk of causing harm to a patient, donor or to an embryo. A critical area of non compliance requires immediate action to be taken by the Person Responsible

Area of practice Reference Action required Timescale for action

PR Response Executive Review

NONE

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� Major area of non compliance A major area of non compliance is a non critical area of non compliance:

• which poses an indirect risk to the safety of a patient, donor or to an embryo through the procurement, use, storage or distribution of gametes and embryos, which do not comply with the centre’s licence;

• which indicates a major shortcoming from the statutory requirements; • which indicates a failure of the Person Responsible to carry out his/her legal duties • a combination of several “other” areas of non compliance, none of which on their own may be major but which together

may represent a major area of non compliance. Area of practice-1 Action required Timescale PR Response Executive Review The centre’s witnessing remains non-contemporaneous at some steps. A risk assessment has been performed and control measures are in place. Contemporaneous witnessing has however been a licence condition requirement (T71) since 1 October 2009.

Risk assessment of non-compliance is no longer enough and contemporaneous witnessing is now a Licence Condition requirement. The PR must take actions to ensure witnessing is performed contemporaneously in a manner compliant with Licence Condition T71.

Immediate Contemporaneous witnessing has now been implemented. This does have some implications for the unit as our staffing levels are small and we plan to audit the process to ensure that it is practicable and does not incur unecessary delays in sample preparation.

22 March 2010. Witnessing processes are now compliant. The centre plans to audit the effect of contemporaneous witnessing on gamete processing time. The Executive notes that staff resources should be made available, if needed, to ensure compliant witnessing without negatively affecting the quality and safety of processed gametes

Area of practice-2 Action required Timescale PR Response Executive Review Gamete sample containers are labelled with the patient surname and date of birth. This is potentially non-compliant with CoP guidance 18.20, which requires that for effective witnessing, all

It is recommended that the centre ensures that samples are at all times labelled in compliance with CoP guidance note 18.20. Where compliance with guidance note 18.20 can not be achieved, any departure should be risk assessed.

Immediate This has been implemented with immediate effect.

22 March 2010. The PR’s response indicates the centre is now compliant

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Continued samples of gametes should be labelled with at least the patient’s full name and a unique identifier.

The PR is advised that compliance with licence condition T101, which states mandatory requirements for sample labelling, must be maintained if any changes in labelling are made

Area of practice-3 Action required Timescale PR Response Executive Review Witnessing was reviewed in 4 sets of patient records. Witnessing signatures were all documented. In one set of records, the time of witnessing was absent.

To comply with CoP guidance note 18.7, the PR should ensure that witnessed procedures are timed, as well as signed and dated, at all times.

Immediate This has been communicated to staff and implemented with immediate effect.

22 March 2010. The PR’s response indicates the centre is now compliant

Area of practice-4 Action required Timescale PR Response Executive Review The inspectorate considers the centre has made efforts to comply with air quality requirements, however it has some concerns and compliance with licence condition T20 is unclear. The flow cabinet is serviced to BS EN 12469, a recognised standard governing the location, safety, performance and testing of microbiological safety cabinets. It was however unclear from the

The PR and Lead Scientist should ensure the air quality monitoring protocol is fully validated (T72) such that it will determine compliance of the air quality with HFEA requirements, as defined in the current European Guide to Good Manufacturing Practice (GMP_ Annex 1 and Directive 2003/94/EC). The air quality in the laboratory background and critical work area should then be re-tested. This will enable the centre to ensure themselves and the HFEA, that it is compliant with licence condition T20

By 31 March 2010

The Lead Scientist has had a meeting with Bovis Lend Lease who are responsible for maintaining the equipment to ensure that particle count and/or settle plate test data is collected for the cabinet and background air. This data will be forwarded as soon as it has been collected.

22 March 2010. The Executive recognises the centre must liaise with Bovis Lend Lease to ensure the testing of air quality is done in a manner which ensures data is collect to support compliance with licence condition T20. The centre should also note the requirement that the air quality monitoring protocol is validated. The Executive accepts the Lead Scientist’s projection that this may take up to the 31 May 2010. The Executive notes however that until

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Continued last test data whether the air quality in the critical work area is compliant because the efficiency of the cabinet’s HEPA filters was assessed, but no particle count or settle plate test data for the air in the flow cabinet was in the report. Background air is compliant with ISO Class 8 but this class approximates, but is less rigorous than, HFEA Grade D, especially regarding the allowable concentrations of particles of >5 micron diameter

The Lead Scientist feels that this may alter the timescale to end May 2010.

air quality is tested using a validated method which provides appropriate data, that compliance with licence condition T20 remains uncertain. The PR should therefore take all appropriate measures to ensure validation and testing are performed at the first available opportunity.

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Area of practice-5 Action required Timescale PR Response Executive Review The Lead Scientist now participates in the NEQAS scheme for sperm assessment. He has however not been formally competency assessed for sperm preparation, which is a breach of licence conditions T12 and T15a.

The inspectorate recommends that the PR ensures that the Lead Scientist’s competence in sperm processing is formally assessed by an appropriately qualified person. Repeat testing should occur at a frequency specified in the quality manual

By 30 April 2010

The Lead Scientist has met with Alan Thornhill at the Bridge Centre and has arranged for an assessment by the lead embryologist at the Bridge Centre. A competency certificate will be issued. We have agreed that this will be an annual requirement and will enter this into our quality manual. Timescale end April 2010.

22 March 2010. The Executive considers that the PR has developed a plan to bring the centre into compliance with licence conditions T12 and T15a regarding on-going competency assessment of the Lead Scientist. Until this plan is implemented however, the centre is non-compliant with licence conditions T12 and T15a. The plan should therefore be implemented as soon as is practicable or by 30 April 2010 at the latest.

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Area of practice-6 Action required Timescale PR Response Executive Review The inspectorate notes that two breaches of licence conditions from the last inspection report, concerning validation and competency assessment, have yet to be corrected. In addition, air quality testing is potentially non-compliant with licence conditions, and was raised as an issue in the previous report

The PR is reminded of HF&E Act (1990) as amended, Section 17, paragraphs 1(b),1(d),1(e), which require the PR to secure that proper equipment and suitable practices are used, and that licence conditions are complied with, in the course of providing licence treatment. It is recommended that the PR consider whether the time allocated in her work plan to focus on PR duties is adequate considering the regulatory load at this licensed IUI centre which has a relatively large transport IVF workload.

31 March 2010

The job plan for the PR is currently under review and the time allocated specifically to PR duties will be discussed with the Lead Clinician. The time scale for job plan review in the department is end March 2010 but due to some major changes in the department this may be deferred until end May 2010 (currently under debate/consultation).

22 March 2010. The Executive considers the PR is taking appropriate actions to ensure she has the time available to perform the role in a manner compliant with HF&E Act (1990) as amended, Section 17, 1b,d,e

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Area of practice-7 Action required Timescale PR Response Executive Review All staff undergo a trust induction. A centre-specific induction with training and competency assessment has been established for nursing staff, but not for other staff groups.

To ensure compliance with licence conditions T12 and T15a, the PR should ensure that induction programmes, with training and competency assessment in key activities, are prepared for all staff groups at the centre.

30 April 2010 There is a document outlining general induction programme for medical staff conducted at Kingston Hospital within the quality manual. A specific induction programme for ACU medical staff with training and competency assessments will be prepared and added to the quality manual by end April 2010.

22 March 2010. The Executive considers that the PR has developed a plan to bring the centre into compliance with licence conditions T12 and T15a regarding medical staff induction with competency assessment. Until this is implemented however, the centre is non-compliant with licence conditions T12 and T15a. The plan should therefore be implemented as soon as is practicable or by 30 April 2010 at the latest.

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Area of practice-8 Action required Timescale PR Response Executive Review On-going competency assessment is in place for nursing staff but documented competency assessment plans were not available for other staff groups, contrary to licence condition T15a

To ensure full compliance with licence condition T15a, on-going competency assessment programmes should be prepared for the other staff groups besides the nursing staff. These plans should focus on the key activities for each staff group. It should be documented in the quality manual the frequency with which staff should undergo competency assessment.

31 March 2010

Competency assessments for ultrasound scanning and intra-uterine insemination will be performed by 31.3.10 and certificates forwarded.

22 March 2010. The Executive considers that the competency assessments planned are appropriate for the medical staff and that the Lead Scientist’s competencies will also be assessed (Area of Practice-5). 31 March 2010. The PR provided competency assessment documentation for staff performing intrauterine insemination and transvaginal ultrasound, dated 24 March 2010. The Executive note that documented competency assessment protocols for each staff group, stating which key competencies will be assessed and the frequency of assessment, still need to be documented, to be compliant with licence condition T15a. The protocols should be written as soon as is practicable or by 30 April 2010 at the latest

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Area of practice- 9 Action required Timescale PR Response Executive Review It was noted that some quality indicators are in place (e.g. sperm motility after processing; CPR and live birth rate in transport IVF patients) and that audits have been performed. The centre still have to develop quality indicator monitoring and audit for information provision, consenting, procuring, processing and transporting gametes and embryos, witnessing, the quality management system, confidentiality and record keeping and document control, contrary to licence condition T35.

To ensure compliance with licence condition T35, the PR should review activities at the centre and ensure that required standards of quality and safety, in the form of quality indicators for all activities authorised by the licence and other activities carried out in the course of providing treatment services that do not require a licence, are established. The activities should include those described, though the PR may choose to include others. The PR should also ensure that the monitoring mechanisms, audit frequencies and responsibilities for the new quality indicators developed are documented, to comply with CoP guidance notes 23.19 – 23.22.

By 31 March 2010

Checklist for IUI has been prepared to include information given, consent completed, correct witnessing & ID of sample, WOC complete. Annual audit of checklist & traceability. Computer system has checks to prevent data being sent out if consent to disclosure not completed. QMS review 14.5.10 agenda to include workload, staffing, premises, QI, patient satisfaction survey etc..

22 March 2010. The Executive considers that the PR has developed appropriate processes to bring the centre into compliance with licence condition T35 regarding quality indicator monitoring. Quality indicators will be reviewed annually at the QMS review. The proposed annual review satisfies regulatory requirements, however the Executive suggests more frequent monitoring of certain quality indicators so that any system failures are likely to be more rapidly detected.

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Area of practice-10 Action required Timescale PR Response Executive Review The procedures associated with information provision, procuring, processing and transporting gametes and embryos, the quality management system, maintaining patient confidentiality, and record keeping and document control, remain to be audited against HFEA regulatory requirements. This is a breach of licence condition T36. This is of notable concern as some procedures appeared to be last reviewed well before that date.

To comply with licence condition T36, the PR should have these procedures audited against HFEA regulatory requirements to ensure their compliance. Non-conformities and corrective actions should be documented.

By 31 March 2010

Rolling audit programme to be established to include 6 main areas for audit (3 per year to be audited biennially).Outstanding audits realistically to be completed by end May 2010.

22 March 2010. The Executive considers that the PR’s plans will bring the centre into compliance with licence condition T36 regarding the audit of compliance of procedures with regulatory requirements. Until this is implemented however, the centre remains non-compliant with licence condition T36. The plan should therefore be implemented as soon as is practicable or by 31 May 2010 at the latest.

Area of practice-11 Action required Timescale PR Response Executive Review Validation of key processes has not been completed, contrary to licence condition T72.

To comply with licence condition T72, the PR should ensure key processes are identified and validated.

By 30 April 2010

Validation of key processes (including sperm preparation, insemination procedure) to be completed by end May 2010.

22 March 2010. The Executive considers that the PR’s plans will bring the centre into compliance with licence condition T72 regarding process validation. Until this is implemented, the

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Continued centre is non-compliant with licence condition T72. The plan should therefore be implemented as soon as is practicable or by 31 May 2010 at the latest.

Area of practice-12 Action required Timescale PR Response Executive Review A review of the centre’s QMS has not been conducted yet, but one is planned in May 2010. This must be carried out to ensure compliance with HF&E Act (1990) (as amended) Schedule 3A, paragraph 10 and the European Union Tissue and Cells Directive 2006/86/EC, Annex I, part F.

The centre’s quality management review must be performed as scheduled in May 2010, to ensure compliance with HF&E Act (1990) (as amended) Schedule 3A, paragraph 10. The PR should also ensure that the QMS review is carried out in compliance with CoP guidance notes 23.12 – 23.15.

31 May 2010 QMS review due on 14.5.10. Agenda to include items 23.12-23.15.

22 March 2010. The Executive considers that the PR’s plans will bring the centre into compliance with HF&E Act (1990) (as amended) Schedule 3A, paragraph 10. regarding review of the QMS. The PR should note that QMS review must be performed at least annually and this should be documented

Area of practice-13 Action required Timescale PR Response Executive Review The Lead Scientist deep cleans the laboratory himself at intervals. The premises and equipment cleaned on these occasions is not logged, contrary to licence condition T26.

The Lead Scientist should document when deep cleans in the laboratory are performed, and what equipment is cleaned, to ensure compliance with Licence condition T26.

31 March 2010

Required documentation procedures have been implemented with immediate effect.

22 March 2010. The Executive considers the centre is now compliant with regard to the logging of equipment cleaning.

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Area of practice-14 Action required Timescale PR Response Executive Review On inspection, it was seen that all disposables are CE marked except one type of tube from a US manufacturer. This is potentially contrary to licence condition T31. These tubes have also not been sperm motility tested.

The Lead Scientist should ensure that all disposables comply with the centre’s documented requirements and specifications for materials used in the centre’s activities, as required by licence condition T31.

31 March 2010

The Falcon tubes that are not CE marked are used by many units throughout the country. They have been in use here for many years and LBR have not been compromised. We have approached the Bridge Centre for advice on batch testing of the tubes.

22 March 2010. The Executive accepts the PR’s point regarding the common use of this tube and that the centre’s live birth rates are not lower than other IUI centres. Compliance with licence condition T31 is expected of all centres though, thus the approach to another HFEA licensed centre for advice is useful. Until corrective actions are developed and taken, the centre is non-compliant with licence condition T31.

Area of practice-15 Action required Timescale PR Response Executive Review Validation of key equipment has not been completed, contrary to licence condition T24.

To comply with licence condition T24, the PR should ensure key equipment items are identified and validated.

31 March 2010

Validation of the centrifuge, catheters for insemination, preparation medium, air flow hood, microscope and ultrasound machines will be performed. A realistic time scale for this is end April 2010.

22 March 2010. The Executive considers that the PR’s plans will bring the centre into compliance with licence condition T24. Until this is implemented, the centre is non-compliant. The plan should therefore be implemented as soon as is practicable or by 30 April 2010 at the latest.

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� Other areas of practice that requires improvement Areas of practice that requires improvement is any area of practice, which cannot be classified as either a critical or major area of non compliance, but which indicates a departure from good practice.

Area of practice-A

Action required Timescale PR Response Executive Review

The centre has identified processes and procedures which carry significant risk. Documented risk assessments for them have been performed. These were available for inspection and appeared to be of suitable rigour to accomplish effective risk management.

The inspectorate recommend that these risk assessments are reviewed annually, and that further risk assessments are performed if needed because of changes in procedures

On-going An annual review of the risk assessments has been programmed to take place in January of each year.

22 March 2010. The Executive considers that the PR’s plans will ensure risk assessments remain up-to-date within the centre.

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Area of practice-B Action required Timescale PR Response Executive Review Some documents in the QMS were, according to their document control footers, last reviewed more than a year before the inspection (e.g. the confidentiality procedure and IUI information pack). This is contrary to CoP Guidance 31.6.

The QM is reminded of CoP Guidance 31.6 (‘Documents should be reviewed, revised and reapproved at a frequency that ensures they remain fit for purpose. The maximum interval between reviews should be 12 months). The QM should review documents within the QMS for compliance with the guidance and take action to correct non-compliance.

30 April 2010 QM documents not reviewed in appropriate time scales will be reviewed and discussed at the QM review therefore timescale for completion 14.5.10. Annual review of controlled documents now scheduled for December each year and to be completed by 31.12.10.

22 March 2010. The Executive considers that the PR’s plans for document review will ensure the centre’s documents are annually reviewed, compliant with CoP guidance 31.6.

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Area of practice-C Action required Timescale PR Response Executive Review The centre did not appear to have a procedure in place for responding to requests for access to patient records, and providing such access, in a manner compliant with licence condition T44

The PR should review the requirements of T44 and ensure that such a protocol is either in place or is documented, to achieve compliance with this licence condition.

30 April 2010 SOP for response to requests for access to patient records to be written by QM within timescale. It is our routine practice to send patient information only to patients for them to forward to whom they feel is appropriate. This avoids any possible breach of confidentiality.

22 March 2010. The Executive considers that the PR’s plans will ensure patients can access their records in an appropriate manner compliant with licence condition T44. Until the SOP is developed however the centre remain non-compliant with licence condition T44, therefore the plan should be implemented as soon as possible.

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Additional Information from the Person Responsible I welcome the comments made in the interim inspection report. As you have recognised we are a small but busy unit! In view of this I have amended a number of the timescales and I hope you that you are happy to accommodate these revised timescales.

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