agenda for January 2009 Authority meeting by annieparksi

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									Thirty sixth meeting of the Human Tissue Authority Date 19 May 2009 Time 10.30am – 4.00pm Venue HTA Boardroom 15 – 17 Furnival Street London EC4A 1AB Agenda (I) = for information; (D) = for decision

1. 2. 3. 4. 5. 6. 7. 8. 9.

Welcome and apologies Declarations of interest Minutes of 17 March 2009 Matters arising Codes of practice License fees Annual report back meeting Chair’s report Strategic Performance Review (I) Report back from Audit Committee (I) Annual Report and Accounts 2008/09 (I) Strategy for Licensing, Enforcement, Investigation and Inspection (D) Oral HTA (15/09) Oral HTA (16/09) HTA (17/09) HTA (18/09) Oral HTA (14/09)

10. Significant Regulatory Action Report 1 January – 31 March 2009 (I) 11. Any other business 12. Confidential session 13. Private session (members only) 14. Lunch 15. Strategic session

12.15pm – 1.00pm 1.00pm – 4.00pm

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Minutes of the thirty fifth meeting of the Human Tissue Authority Date 17 March 2009 Venue Midland Hotel Peter Street Manchester M60 2DS Present Members Ms Shirley Harrison (Chair) Mrs Jodi Berg Dr Kate Robson-Brown Mr Brian Coulter Professor Ceri Davies Mrs Pamela Goldberg Professor James Ironside Ms Ruth Musson Dr Andrew Reid Mr Keith Rigg Ms Catharine Seddon Ms Helen Shaw Professor Sir James Underwood In attendance Mr Adrian McNeil (Chief Executive) Ms Vicki Chapman (Director of Policy and Strategy) Mr Geoff Gibbs (Interim Director of Resources) Dr Shaun Griffin (Director of Communications) Dr Sandy Mather (Director of Regulation) Ms Priya Goyal (Authority Secretary) Observers Mr Peter Jones (Department of Health)

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Item Item 1

Title Welcome and apologies 1. The Chair welcomed members of the public to the sixth public meeting and said that the Authority was pleased to see the record number registering to attend. 2. She added that Manchester was a centre of excellence for cancer and medical research and extended her congratulations on the recent award of Academic Health Science Centre status. 3. The Chair explained that the meeting would be divided into two parts, with the two substantive items at the beginning, followed by a question and answer session. The standing items and other matters would be dealt with in the second half of the meeting after lunch. 4. She formally welcomed Geoff Gibbs, the new interim Director of Resources, and said goodbye to Priya Goyal, Authority Secretary and Head of Policy. She said on behalf of the Authority that she was very appreciative of Priya Goyal’s contribution and she wished her well in her future role. 5. The Chair also said goodbye to two Authority Members, Ms Michaela Willis (in her absence) and Professor James Underwood. She extended her warm thanks for their very valuable contributions to the Authority and for keeping the Authority focused on why it had been set up. James Underwood replied, adding his own thanks to Michaela Willis. He felt privileged to have been a Member of the Authority and was impressed by what it had achieved. 6. Apologies had been received from Professor Michael Banner and Ms Michaela Willis.

Action

Item 2

Declaration of interests 7. Kate Robson-Brown and Ceri Davies declared interests as persons designated on licences for their establishments.

Item 3

Revised codes of practice: remaining issues [paper: HTA (07/09)] 8. Vicki Chapman introduced the item. 9. She said that the revision of the codes of practice had been an exhaustive process and the project was now in its final stages. She acknowledged the hard work that had been put into the process by all those involved, including the Executive and Members. 10. She added that comments from Members, the Department of Health (DH) and the Devolved Assemblies had now all been incorporated. The next step would be to liaise with DH solicitors before formal sign-off by the Secretary of State; the revised codes would then be laid before Parliament. She said that if the codes were approved by Parliament, the final

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versions would be published on the HTA’s website in September this year, together with Directions bringing the revised codes into force and a rationale explaining how the Authority had dealt with the comments raised during the consultation. 11. Vicki Chapman explained that the aim of the discussion was to agree the text on the two remaining issues, which had been debated at the joint meeting of the policy and regulation Members’ groups. 12. On the first issue on the retention and disposal of tissue following a coroner’s post-mortem examination, Brian Coulter said that he welcomed the revised text as it preserved the principle of treating human tissue in a dignified way, whilst removing uncertainty about how communication channels should be handled. He said that there was some slight inconsistency in the semantics used in the text which would VC benefit from further consideration. He also suggested that the text should make it clear that if families did not make a decision about what they wished to happen to the tissue, it would be disposed of after three months. 13. Andrew Reid added that a meeting was being hosted by the Ministry of Justice at the beginning of April which might inform the model protocol and the roles and responsibilities of coroners and pathologists; the protocol would be published on the HTA’s website once finalised, and the link included within the codes. 14. On the second issue on consent decisions in respect of fetal tissue and stillbirths, Members agreed the revised text as set out in the paper. 15. It was agreed that the final text on both issues would be incorporated into the codes, which would then be sent to DH solicitors. Item 4 Licence fees 16. Adrian McNeil introduced this item. 17. He emphasised that the Authority took consultation seriously. He also explained how complex and multi-faceted the Authority’s regulatory remit was, especially in the human application sector as a consequence of the European Directives on tissues and cells. He added that recruiting new staff had taken longer than anticipated, and therefore the Authority had looked to make reductions in the proposed fees, within the limits of what was financially prudent. 18. Adrian McNeil said that the Authority proposed to look again in 2009/10 at how fees might be charged by activity within each of the sectors; and that it would look also at where it might further reduce the cost of regulation. He explained that the Authority would need to keep to the revised fee structure for 2009/10 until then. He added that a rationale setting out how the Authority arrived at its revised fee structure would be [paper: HTA (08/09)] VC

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published on the HTA’s website. 19. Catharine Seddon asked how the proposed fees compared with those charged by other regulators. Adrian McNeil said that an initial analysis had been undertaken but that it was difficult to compare like for like costs. He said the most important thing was for the Authority to be assured that it was conducting the necessary activities under its remit at minimum cost. 20. Catharine Seddon also asked whether the size of the establishment would be taken into account in the revised fee structure. Adrian McNeil responded that smaller size did not necessarily equate to less risk, and therefore a reduced fee. He also added that it was important to avoid incurring more costs for the Authority by undertaking a detailed costing exercise for each activity. 21. The Chair said that the Authority had undergone a review by the Department for Business, Enterprise and Regulatory Reform (BERR) in December 2008 (based on the March 2005 report by Philip Hampton Reducing Administrative Burdens: Effective Inspection and Enforcement). Initial feedback had suggested that the Authority was regulating according to the principles of better regulation, including adopting a risk-based and proportionate approach. 22. James Ironside asked about the surplus and how it might be used in a revised fee structure. Adrian McNeil said that the intention was to review whether it was possible to use the surplus as part of the new fee proposal after 2009/10. 23. Members agreed the reductions to the fees for satellites, that there would be no fee for third party agreements in 2009/2010 and the revised fee structure for 2009/10. 24. Members agreed that when fees were considered again in 2009/10 with a view to proposing a new structure for 2010 and beyond, it would be important to look at how the surplus might be used to reduce the cost to licensed sectors. Further thought should also be given to a stratified approach taking account of the cost effectiveness of such an approach, and whether there was any scope for costing by activity within each sector. In addition, the review should look at the pros and cons of a fixed fee for three years against an annual charge and indicative fees for the next two years. 25. Clear transparent messages on the revised fee structure should be communicated to the sectors; and for the next consultation, stakeholders should be notified of any changes as far in advance as possible to enable them to plan their budgets. The meeting adjourned to allow for a forty five minute question and answer session, followed by lunch. Item 5 Chair’s report 26. The Chair said that following the Members’ away-day in February, the strategic plan would be revisited during the

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afternoon of the Authority meeting in May. She added that further work would be done with Members’ groups before the meeting with a view to reviewing and revising the strategic aims and objectives for 2010/11. She thanked Members for their contributions to the process so far. 27. The Chair said that this year’s annual report-back meeting would be held on 14 July where the annual review would be launched; further details would follow on the HTA’s website. Item 6 Chief Executive’s report [paper: HTA (09/09]

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28. Adrian McNeil introduced the item. He provided an update on HTA organisational development under the three areas: Recruitment  The recruitment process had not been as successful as had been hoped, but the Authority aimed to recruit to its full complement of staff by October this year. The budget had been remodelled accordingly. Accommodation  The office move to the second floor would take place over Easter as planned; the process was being managed by Geoff Gibbs. Service agreements  Service agreements with the HFEA were on target to be terminated by the end of March 2009. Options on how to resolve the issue of staff pensions were being considered. 29. Vicki Chapman gave an update on the key elements of the policy directorate’s work. 30. Under objective 1 (legislative changes), she said that the Authority had been involved in developing the negotiating strategy with DH on the EC Donation Directive, together with other stakeholders. She added that the Authority was currently in discussion with DH about which organisation(s) might fulfil the competent authority role. 31. Under objective 15 (manage the live organ and bone marrow transplant approval programme), she provided a breakdown of the number of Independent and Accredited Assessors who had been reaccredited. 32. Sandy Mather gave an update on the key elements of the regulation directorate’s work. 33. Under objective 1 (legislative changes), she said that the Authority would be meeting with DH to discuss how to maintain a proportionate approach towards end users of acellular material within the framework of the Quality and Safety Regulations. 34. Shaun Griffin gave an update on the key elements of the communications directorate’s work. 35. Under objective 5 (major existing stakeholder relationships SG/SM SM VC AM GG SMT

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are reviewed), he said that the research evaluation project which aimed to assess the impact of human tissue legislation on tissue based research had closed on 20 March. He explained that the results from this project would inform future advice and guidance that the Authority issued to the research sector. 36. Under objective 2 (develop a proportionate regulatory approach), he said that the stem cell route map, which aimed to guide stem cell researchers through the requirements of different legislative frameworks, was due to be published later this year. 37. Under objective 9 (targeted sector-specific communications are developed), he reported that a ‘new look’ HTA website would be launched in June, which would include an enhanced search capacity. He added that the content would be updated throughout the rest of the year. 38. Geoff Gibbs gave an update on the key elements of the resources directorate’s work. 39. He said that the Audit Committee would consider the Internal Audit Plan for 2009/10 at its May meeting and ensure that the proposed audits brought added value to the Authority and were realistically scheduled to minimise disruption to staff workloads. 40. Under objective 23 (arrangements have been put in place to maintain a stable workforce), he said that a performance assessment model had been developed. 41. Jodi Berg said that it would be useful to arrange a lessons learned session on the Appeal that had recently been held. 42. Under objective 3 (ensure that we meet our required duties and obligations), Jodi Berg also asked about the nature of the serious adverse events that had been reported. Sandy Mather said that most of these related to eye banks and whether the correct procedures had been in place for ensuring the quality and safety of ocular tissue. 43. Ruth Musson asked about recruitment of staff in the regulation directorate. Sandy Mather said that five of the posts had been filled. She added that since the Authority had employed a dedicated HR resource, the recruitment process had been smoother. Item 7 Financial report 44. Geoff Gibbs presented this item. 45. He said that a £14k surplus was expected at the end of the current financial year which was a commendable result. 46. He added that the Authority would continue to put pressure on debtors in order to collect as much income as possible by year-end. 47. Geoff Gibbs invited Members to provide feedback on how the format, content and style of future reports might be [paper: HTA (10/09)]

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improved. 48. Members noted the financial position. Item 8 HTA budget 2009/10 49. Geoff Gibbs presented this item. 50. He mentioned that the income forecast included the recommended licence fee increases and the expenditure reflected the agreed establishment of 67 staff. He explained that it was a ‘break-even’ budget. 51. Geoff Gibbs explained that in Appendix 1, 2009/10 budget summary, a comparison of the year on year increases in the CEO and Board budget, might be misleading. Certain expenditure, including recruitment and other HR costs, corporate staff development and strategic away-days had now been included in the CEO and Board budgets respectively. 52. He apologised for three inaccuracies in the paper:  In table 3, the variance for staff related costs should read £232k, and for organisational development costs, £346k.  In table 4, the budget year in the first column should read 2009/10.  In table 4, there should be no brackets around the £410k in the variance column for DH capital funding. 53. Members approved the Authority’s budget for 2009/10. Item 9 HTA strategic plan 2009/10 54. Vicki Chapman presented the paper. 55. She explained that the attached draft of the strategic plan had been updated to take account of comments at the January Authority meeting. 56. She reminded Members that, following the away-day in February, further work would be done through Members’ groups and the May Authority meeting, with a view to reviewing and revising the strategic aims and objectives for 2010/11. 57. Members noted that the current draft of the strategic plan for 2009/10 would be used by the Executive to prepare a more detailed business plan for sharing with DH by the end of the month. Item 10 Minutes of 20 January 2009 [paper: HTA (13/09)] All [paper: HTA (12/09)] [paper: HTA (11/09)]

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58. The Chair said that as part of the new process for Authority papers, the Executive would be sending out the Minutes for Members to agree accuracy via email, as had been done this time round with the Minutes from the January meeting. Matters arising would be discussed in the usual way during the meeting. 59. The minutes had been agreed as an accurate record.

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Item 11

Matters arising 60. Paragraph 6: Vicki Chapman said that an ad-hoc group on the definition of death was being arranged, with a paper for Members’ consideration. She added that recommendations would be shared with the Authority. 61. Paragraph 42: James Ironside asked about the guidance for Independent Assessors (IAs) and transplant teams. Priya Goyal said that a list of revisions had been compiled and the guidance document in its entirety would be revised in the next business year.

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Any other business 62. None was raised.

The meeting closed at 15.00 pm

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Authority paper Date Paper reference Author HTA (15/09) Vicki Chapman

19 May 2009

Agenda item 6

Strategic Performance Review Purpose of paper 1. The attached document, which replaces the monthly CEO’s report, provides information to Members about progress against key activities during April.

Background 2. The current draft of the strategic plan, which was discussed by Members in January and March, provided the basis for the executive to identify the critical strategic aims and their associated high level activities. Alongside these are the key performance indicators (KPIs) that will demonstrate whether these strategic aims are being delivered. The strategic plan also provided the basis for the executive to develop a detailed business plan for 2009/10. This business plan, which has been shared with the Department of Health, contains performance indicators (PIs) for all activities. The SMT will use this document to review progress, not just against the KPIs, but all other activities and their associated PIs.

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Strategic Performance Review - April 4. The report is based on a traffic light system: Green (activity on track to deliver on time); Amber (risk of failing to deliver on time or at all); Red (serious risk of failing to deliver); Blue (activity completed).

Conclusion 5. Members are asked to note progress and to comment on the attached report.

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Strategic Performance Review - April 2009
Implement human tissue legislation in a way that promotes safe and ethical practice and is conducted in accordance with the wishes of the individual.
Objective 1. Interpret and implement the principles embodied in the HT Act, EUTCD, and any future relevant European legislation. 2009/10 High level activity Apply all appropriate licensing, inspection, enforcement and regulatory tools to ensure establishments are licensed in accordance with domestic and European legislation. Business plan activity to be measured Implement a risk based schedule of inspections. Delivery update Directorate Reg Key Performance Indicators Each regulation manager to participate in an average of six inspections per quarter in accordance with standard operating procedures, working instructions and associated quality guidance. All inspection reports are proportionate and evidence based, and at least 90% are issued to Designated Individual and Licence Holder within 28 days of phase two inspection. Appropriate sanctions are applied for all regulatory non-compliances and at least 90% of them are issued within 63 days of the phase two inspection. Written feedback about the inspection process is analysed and key themes with remedial quality improvement measures are reported to the Authority twice a year. 90% of licence conditions are compliance assessed within 28 days of the condition deadline and appropriate enforcement action is taken for non compliance. Reaccreditation completed by end Q4. A G M J J A S O N D J F M Comment

Collect and analyse data to compare risk found at phase one and phase two inspection to ensure that risk is correctly assessed.

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Amber because 28 days has not elapsed so status unknown.

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As above.

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Apply regulatory enforcement policy.

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Only two conditions expired in April; one is under assessment and the other is awaiting a response from the DI following a request for more information.

Regulate living organ donation.

Reaccreditation of all IA and AA.

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Maintain the confidence of the public and professionals and continue to work in partnership with them.
2. Operate our regulatory framework in a way that gives confidence to professionals and the public. Continue to build and maintain relationships with new and existing stakeholders. Review stakeholders in patient groups, private and other ‘crosscutting’ sectors and develop a programme for engagement. Comms Pol Produce updated stakeholder map by Q2. A Amber as we plan to complete in Q3 when we have more staff resources.

Evaluate the impact human tissue legislation on our stakeholders.

Create better understanding of the impact of HT legislation and regulation on the research community and communicate findings to sector and DH.

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Launch research evaluation report by Q2.

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Report received from Opinion Leader Research and discussed by SMT members.

Maintain the confidence of the public and professionals and continue to work in partnership with them.
Objective 3. Engage, consult, communicate and work with our stakeholders to help refine our advice and guidance, standards and regulatory methods. 2009/10 High level activity Improve and refine our communications materials and routes. Business plan activity to be measured Conduct audit of the HTA's communication activities, advice and guidance meetings and events to inform communications strategy and produce quality audit report informing new communications strategy and future direction. Directorate# Comms Key Performance Indicators A Quality audit report produced Q3. G M J J Delivery update A S O N D J F M Comment

Be recognised as an organisation that makes the best use of the knowledge and information it holds.
4. Make best use of knowledge and quality management systems and processes and provide a responsive service to internal and external stakeholders. Review and refine our Information Management Platform and Communications Tool (IMPACT). Conduct audit of organisational policies and procedures in each directorate. Res All directorates’ policies and SOPs have been reviewed to ensure they are proportionate, consistent, and clear, minimise resource inputs and are available in IMPACT Q2. New enquiries log and system launched Q1. All staff trained to use new system Q1. G

Review and improve procedures for handling complaints and enquiries from stakeholders.

New enquiries log and system fully developed and all staff trained to use it.

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In April pilot training sessions launched. Formal launch on schedule for 11 May 2009.

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Ensure that the HTA is a distinctive dynamic organisation that people want to work for.
5. Create an organisation with a strong corporate culture. Implement the HTA’s HR strategy. Complete values exercise with staff and Authority and establish baseline for awareness. CEO Publish revised HTA values in Q3. G

Continue to apply the principles of better regulation and provide value for money for the taxpayer and licence fee payer.
6. Find the most economical, efficient and effective ways of delivering the service. Implement new licensing and inspection IT platform. Fully implement CRM, with full LMS, enquiries, contacts and calendar functionality – as identified in the project requirements document. Comply with DH Gateway requirements by submitting our national communications to Gateway for approval. Res CRM fully implemented Q4. G

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All relevant communications receive Gateway approval

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No Gateway approval needed this month. The next approval will be for publication of the fees rationale document, the next fees consultation, and the codes of practice launch.

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Authority paper Date Paper reference Author HTA (16/09) Geoff Gibbs

19 May 2009

Agenda item 8

Annual Report and Accounts 2008/09 Purpose 1. The Authority is invited to note the draft Annual Report and Accounts for 2008/2009 (Annex A). This is still in draft form pending completion, expected by 29 May, of the audit by the National Audit office (NAO). Given the very tight timescale for laying the Report and Accounts before Parliament, Members are asked to agree to delegate approval of the final document to the Chair & Chief Executive. Background 2. The HTA is required to produce its Annual Report and Accounts under section 36 and paragraph 16 of Schedule 2 of the Human Tissue Act. The Annual Report and Accounts is required by the Companies Act, the Government Financial Reporting Manual, HM Treasury’s guidance Managing Public Money and the Cabinet Office’s requirements. The NAO’s Audit of the 2008-2009 Annual Report & Accounts 3. The latest version of the 2008-2009 Annual Report and Accounts was considered at this morning’s Audit Committee. Their comments will be incorporated. It has also been reviewed by the National Audit Office in order to provide the basis for the opinion of the Comptroller and Auditor that is included in the Report. 4. The NAO carried out an interim audit on the ’hard close’ exercise (i.e. the 9 months to 31.12. 08.) in February 2009. They returned after the end of the financial year in April to commence their year-end audit. They requested various revisions to certain figures and made some suggestions for improving the

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accompanying narrative. All these amendments have been incorporated into the version of the Annual Report & Accounts presented to the Audit Committee and the Authority today. NAO intend to return next week to undertake a final week’s audit work which they will complete by 29 May. Their management letter will need to be considered at the next meeting of the Audit Committee. 5. More immediate is the need to comply with the requirements of HM Treasury as even more challenging deadlines have been set this year for the completion, sign-off and production of Annual Report and Accounts. The HTA is required to lay these in the libraries of both Houses by 12 June 2009. The NAO have offered to assist the HTA with this process. 6. However there is less than a fortnight following the end of the NAO audit to complete this process. Hence the need for agreement by the Authority today that the final version of the Annual Report and Accounts for 2008-2009 is approved by the Chair & the CEO through the use of delegated powers. Remaining steps for completion of the 2008-2009 Annual Report & Accounts 7. Keeping to the following timetable will ensure the HTA meets the mid-June deadline:        19 May - Audit Committee reviews the version sent to them supplemented, if necessary, by verbal updates from the NAO & HTA’s Director of Resources. 19 May – Authority receives an update from the earlier Audit Committee meeting by the Chair & Director of Resources. 29 May – NAO complete their 2008-2009 audit work. 1 June – final revisions made following NAO audit. By 5 June – Annual Report & Accounts approved by the Chair & the CEO under delegated powers. By 12 June – HTA (with the assistance of the NAO) lays its Annual Report and Accounts for 2008-2009 before Parliament. Once laid before Parliament, the Annual Report and Accounts will then be published on HTA’s website. A limited number of printed copies will also be made available.

Conclusion Members are invited to:   note the draft Annual Report and Accounts agree to delegate approval of the final document to the Chair & Chief Executive.

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Authority paper Date Paper reference Author HTA (17/09) Sandy Mather

19 May 2009

Agenda item 9

Strategy for Licensing, Enforcement, Investigation & Inspection Purpose of paper 1. A new Licensing, Enforcement, Investigation and Inspection (LEII) team was created between October and December 2008 as part of the strategic expansion of the Regulation Directorate and HTA more widely. 2. This regulatory strategy describes the three key objectives for Licensing, Enforcement, Investigation and Inspection for the two year period 2009-11. The paper also explains how each strategic objective will be met. Recommendation 3. That Members approve this two year strategy for Licensing, Enforcement, Investigation and Inspection. Background 4. The LEII strategy has been informed by comments from Members during Authority meetings, the 2009 Away day and the Communications Members’ Group meeting. 5. This strategy paper is a summary of a more detailed document that was discussed at the Regulation Members’ Group meeting in April 2009. The underpinning detailed document is available to Members on request. The strategy 6. The three key strategic objectives for 2009-11 are as follows.    To build an improved infrastructure. To improve the collection, analysis and use of information. To increase the transparency of regulatory actions.

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7. The underpinning methods which will be used to achieve each strategic objective are described below. Strategic objective one: to build an improved infrastructure 8. A commercially available Customer Relationship Management (CRM) IT system will be implemented by January 2010 to replace all existing custom built IT licensing, enforcement and inspection systems and databases. This is part of a larger HTA wide project. Standard operating procedures to support the existing licensing and inspection systems will be reviewed and processes improved by July 2009 for incorporation into the new CRM system. 9. The HTA’s risk matrices will be revised for incorporation into the new CRM system by January 2010. 10. A template and process to provide a summary of the licensing status and outcomes of inspections and enforcement action at each licensed establishment will be developed by September 2009. This information will be extracted direct from the CRM and uploaded onto the website. These templates will be piloted by December 2009 and implemented from April 2010. 11. A gap analysis will be undertaken by December 2009 to identify where new guidance needs to be produced for the public, professionals and HTA staff to explain our regulatory powers, policies and procedures. This will lead to improved information for licensed establishments and others to understand how we make regulatory decisions and can be challenged on those decisions. Any existing guidance will be reviewed (and if necessary improved) by March 2010 and any new information will be drafted and published by September 2010. 12. Scoping work to implement the European Commission (EC) single European coding system for tissues and cells will be undertaken during the 2009/10 business year in preparation for EC directions requiring its implementation. Strategic objective two: to improve the collection, analysis and use of information 13. The majority of fixed term licences will be reissued as continuous licences by September 2009 to reduce the amount of unnecessary data collection from licensed establishments. This new system will be implemented alongside a new sector-specific system of gathering compliance information to enable robust licence control measures to be implemented in an ongoing way. 14. Improved collection and analysis of data in risk matrices will ensure that risk assessments reflect the risk of non-compliance at each licensed establishment and are used to target our regulatory and inspection resource. 15. Information received as the result of whistleblowers, complaints, serious adverse events/reactions and investigations will be analysed so that trends and repeated issues can be used to improve standards at licensed premises. The timeliness and consistency of HTA responses to whistleblowers and complaints will also be evaluated and monitored. Information on both the content and process will be used strategically and reported to the Authority to monitor HTA’s

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performance. It will also be used operationally to transfer knowledge between regulatory staff. 16. An options appraisal of the feasibility and impact of creating and implementing a system for reporting serious adverse events from the post mortem, anatomy, research and public display sectors will be undertaken by March 2010. This will include how information could be analysed and used to improve compliance with HTA standards and Codes of Practice. 17. A regulatory methodology for assessing the suitability of relevant third party premises will be developed in collaboration with licence holders and Designated Individuals, by March 2010. Strategic objective three: to increase the transparency of regulatory actions 18. All inspection reports of site visits to establishments in the post mortem and human application sector will be analysed and trends and issues identified on an annual basis. The summary inspection reports will be published in October each year to share learning with stakeholders. 19. All inspection reports of site visits to establishments in the lower risk sectors of research, anatomy and public display will be analysed and trends and issues identified in a publication every two years (the next analysis will be during 201011). 20. By December 2009, the website will be updated in conjunction with the communications directorate to publicise to other relevant regulators and the public when significant regulatory action is taken. This will help to further evidence the role of the HTA as a transparent and accountable regulator. Conclusion 21. The implementation of this strategy will ensure that the HTA is supported by robust systems and processes to enable it to continue acting as a proportionate regulator making best use of its knowledge and resources. 22. Members are asked to note the strategic objectives and the underlying deliverables and approve this two year strategy for Licensing, Enforcement, Investigation and Inspection.

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Authority Paper Date Paper reference Author HTA (18/09) Sandy Mather

19 May 2009

Agenda item 10

Significant regulatory action report 1 January – 31 March 2009 Introduction 1. This paper summarises the significant regulatory action taken by the Human Tissue Authority (HTA) Regulation Directorate between 1 January and 31 March 2009. Details of the regulatory enforcement action available to the HTA can be found in the Regulatory Enforcement Policy which is published on the HTA website. Legal Notices Special Directions 2. No Special Directions were issued between 1 January and 31 March 2009. Refusal to grant a licence 3. No notices of refusal to grant a licence were issued between 1 January and 31 March 2009. Suspension of a licence 4. No notices of suspension of a licence were issued between 1 January and 31 March 2009.

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Revocation of a licence 5. No notices of revocation of a licence were issued between 1 January and 31 March 2009. Regulatory Action Panels and Heightened Risk Inspections 6. Regulatory action panels (RAPs) are internal panels which consider complex regulatory issues and/or significant regulatory action. Six RAPs were held between 1 January and 31 March 2009. Of these, four RAPs concerned licensed establishments in the post mortem sector and one concerned a licensed establishment in the research sector. One RAP was convened to consider an unlicensed establishment after information was received which indicated that it was carrying out activities licensable under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. 7. Heightened risk inspections occur when the HTA considers that there has been an increase in an establishment’s risk, and we choose to bring the establishment’s inspection date forward. In some cases the establishment may not have had notification before the inspection team arrive. Seven heightened risk inspections were carried out between 1 January and 31 March 2009. The establishments inspected are in the anatomy and post mortem sectors.

Summary of RAPs and heightened risk inspections in the post mortem sector 8. During a routine site-visit inspection of a mortuary facility, the inspection team found several significant areas of non-compliance with HTA standards. The matters of concern included the suitability of the Designated Individual (DI), the cleanliness of the premises, a failure to have carried out audits or risk assessments to date and the use of consent forms which pre-dated the Human Tissue Act 2004. A RAP was held to consider regulatory action against the establishment. As a result of this RAP, the chief executive was contacted and advised that in the circumstances of an unsuitable DI, the HTA had the power to revoke the licence. The HTA chose not to exercise this power at the time and asked the establishment to nominate a new DI to be able to implement the changes stipulated by the 10 proposed additional conditions. The establishment has now nominated a new DI. 9. National media coverage indicated potential non-compliance with HTA standards and codes of practice at an establishment in the post mortem sector. This matter was also picked up by the offices of No. 10 Downing Street who referred the matter to DH and in turn to the HTA. The issues in the HTA’s remit related to the potential prolonged storage of post mortem material and disposal which did not reflect the wishes of the consent giver. A

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RAP was held where a decision was made to conduct a heightened risk inspection. This inspection took place in April 2009. The inspection followed its usual timetable and considered broad themes related to the specific case highlighted by the national media. The inspection team found good systems, procedures and practices in place. The inspection team also found that new systems had been introduced to prevent the reoccurrence of the specific incident. 10. A whistleblower contacted the HTA and made allegations that a licensed establishment had poor practices relating to post mortem examinations and evidencing a lack of respect for the dignity of deceased persons. A RAP was held in December 2008 and a decision was made to carry out a heightened risk inspection. Two site inspections were carried out. The first inspection was unannounced. During the two site inspections, the inspection team found a lack of evidence to fully substantiate the allegations but the results of the inspection warranted some improvement of practices at the establishment. Following the inspection, the RAP was reconvened to discuss appropriate regulatory action. A decision was made to impose four conditions on the establishment’s licence relating to the dignity of the deceased, consent, post mortem practices and staff awareness of the DI’s role. 11. A complaint was received via a journalist regarding the retention of a brain without appropriate consent at an establishment in the post mortem sector. A RAP was convened in December 2008 and letters were sent to discover more information about the incident from the establishments implicated in the complaint. The RAP was reconvened to consider action following the responses. A decision was taken to gather further information and to request that the establishments implicated in the complaint carry out a thorough audit of any retained tissues. A RAP has been reconvened for May to consider the results of these audits. 12. A RAP was held in quarter 3 of the business year after the HTA received information about two establishments in the post mortem sector in receipt of complaints from a member of the public about the quality of reconstruction of a body following post mortem examination. Each of the two establishments concerned was inspected and the inspection teams found that the incident occurred due to  a lack of communication about the potential invasiveness of a postmortem examination when taking consent at one establishment  and the length of storage of the body at the second establishment The inspection team found that the incident did not occur because of poor reconstruction of the deceased. The establishments concerned had, as a result of this incident, updated their consent procedures to ensure clear explanation of the post mortem procedure is provided to relatives. The HTA also issued advice and guidance to the establishments.

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13. A heightened risk inspection was carried out after an incident was reported to the HTA. The incident occurred at an establishment in the post mortem sector where a post mortem examination was carried out on a body that had not been correctly identified. The inspection team found that this incident happened because two deceased bodies had similar names and similar surgical scarring. The inspection team found that the establishment had, as a result of this incident carried out a thorough investigation and introduced suitable procedures that would prevent reoccurrence of this incident. The relatives were informed by the Coroner of this incident. Summary of issues considered at a RAP for an establishment in the research sector 14. A letter of complaint from a bereaved relative was forwarded to the HTA by the Chief Medical Officer. A RAP was convened to discuss the complaint which related to the disposal of unclaimed organs and tissue at an establishment in the research sector. A decision was made to respond to the complaint and a letter has been sent from the HTA to the complainant explaining the reason for the disposal and the establishment’s compliance to regulatory standards. No response has yet been received. Summary of issues considered at a RAP for an unlicensed establishment 15. A RAP was held to consider information received from 3 sources (including another Competent Authority) relating to an unlicensed human application establishment. The information indicated that a UK based division of a European company was conducting unlicensed procurement of umbilical cord blood. As a result of this RAP, the UK division and the European parent company were sent enforcement letters regarding the procurement practices. Confirmation was received from the parent company that all unlicensed UK procurement has now ceased. Summary of RAPs and heightened risk inspections for an establishment in the anatomy sector 16. One heightened risk inspection was conducted at an establishment in the anatomy sector. A RAP was held in Quarter 3 of the business year which dealt with a reported incident and police investigation due to a human body part being discovered part incinerated at a waste disposal site. The RAP found that this matter should be further investigated at the site visit inspection which had already been planned for January 2009. The inspection team found there to be an issue with the dignity of the deceased and a failure of the incinerator company to notify its staff about the material being disposed of. Appropriate advice and guidance to improve practices was issued to the establishment.

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Challenges to licensing decisions Representations 17. The HTA held no representation panels between 1 January 2009 and 31 March 2009 and no stakeholders made written expressions of interest in making legal representations against licensing decisions. Appeal 18. An Appeal Hearing was held in February 2009 following a Representations Hearing in October 2008. The Appellant sought to challenge a notice of refusal to grant a licence on the grounds that the proposed DI was found to be unsuitable. 19. The Appeal Committee upheld the decision to refuse the licence on the grounds that the proposed DI was unsuitable. Conclusion 20. Members are asked to note the significant regulatory action taken by the HTA Regulation Directorate between 1 January and 31 March 2009.

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APPENDIX 1 - SUMMARY DATA Significant regulatory action 1 January 2009 - 31 March 2009 Notice of refusal to grant a licence Notice of suspension of a licence Notice of revocation of a licence Regulatory Action Panels 0 0 0 6 (4 – licensed establishments in the post mortem sector; 1 - licensed establishment in the research sector; 1 unlicensed establishment) 7 0 0 1

Heightened risk inspections Special directions Representations Appeal

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