Minutes of the HTA Histopathology Working Group

Transcription

1 Minutes of the HTA Histopathology Working Group Date 24 October 2014 Venue Boardrooms 1 and 2 Human Tissue Authority Present Members HTA Ms Sarah Bedwell, Director of Regulation (SB) Ms Caroline Browne, Head of Regulation and Chair of HWG (CBr) Dr Christopher Birkett, Head of Regulation (CB) Professor Susan Dilly, HTA Member (SD) Royal College of Pathologists Dr Michael Ashworth (MA) Professor James Lowe (JL) Dr Michael Osborn (MO) In attendance Dr Alan Clamp, Chief Executive Officer (AC) Ms Alice Stockton, Regulation Officer (Secretary, AS) Ms Jo de Bank, Media and Communications Officer (observer) (JdB) Ms Rachel Noble, Head of Corporate Policy and Strategy (observer) (RS) Ms Emer O Toole, Regulation Manager (observer) (EO) Coroners Society of England and Wales Mr Derek Winter (DW) (by teleconference) British Medical Association Dr Anne Thorpe (AT) Home Office Mr Jeff Adams (JA) Mr Dean Jones (DJ) Association of Anatomical Pathology Technology Mr John Pitchers (JP) Institute of Biomedical Science Mr Andrew Usher (AU) INQUEST Ms Helen Shaw (HS) 1

2 Item 1 Welcome and introductions 1. CBr welcomed attendees. She introduced Ms Alice Stockton, who is a Regulation Officer at the HTA and has taken over from Ms Amy Gelsthorpe-Hill as Secretary to the Group. 2. CBr welcomed the following observers from the HTA: Ms Jo de Bank, Media and Communications Officer, Ms Emer O Toole, Regulation Manager and Ms Rachel Noble, Head of Corporate Policy and Strategy. She noted apologies from Professor Guy Rutty, and Dr Fiona Wilcox, and from the HTA, Dr Shaun Griffin and Ms Jenna Khalfan. Item 2 Review of minutes of last meeting (4 April 2014) and matters arising 3. Members had the opportunity to comment on the accuracy of the April 2014 meeting minutes prior to their publication on the HTA website. No futher amendments were requested. 4. Two actions carried over from the October 2013 meeting to the April 2014 meeting were reviewed and confirmed as completed. One related to the production of guidance for Designated Individuals on visiting Home Office-registered pathologists. The guidance has been produced, but SD requested that the format be amended so that it is easier to read on-screen. 5. Actions from the April 2014 meeting were then reviewed. 6. Update on ACTION 1: action complete. CBr had distributed the marked-up version of the code of practice on post-mortem examination prior to its publication on the website. 7. Update on ACTION 2: action ongoing. The CoP on disposal was updated and published in July Separate guidance on disposal following pregnancy loss is in the final stages of drafting (see para 15(iv) below). 8. Update on ACTION 3: action complete. JL sent JA a copy of the draft RCPath guidance on records retention. The final draft is currently available to RCPath fellows for consultation. 9. Update on ACTION 4: action ongoing. For RCPath, MO is leading on the development of a series of post-mortem examination scenarios to guide pathologists on the best way to approach certain types of case, including the retention of tissue for histology and other tests. This is a long-term project, which is likely to take up to two years to complete. The first draft of the first scenario, on cardiovascular death, is nearly finished and will be distributed to HTW members when it is available for consultation. 2

3 10. Update on ACTION 5: action completed. CB circulated advice to HTA Regulation Managers on tissue transfer between establishments for use for research. 11. Update on ACTION 6: action completed. With input from JP, guidance to Designated Individuals on evisceration prior to the arrival of the pathologist was included in the September edition of the HTA e-newsletter. CBr has provided advice to Regulation Managers on action to take should this practice be identified during inspections. CBr thanked JP for his assistance. This issue will be covered in more detail in the next edition of the HTA code of practice on PM examination. 12. Update on ACTION 7: action completed. FW reported back to the Medico-Legal Committee of the Coroners Society about the role of Coroners in monitoring the professional standards of pathologists. 13. Update on ACTION 8: action ongoing. As part of review of guidance around post mortem working, the RCPath s Death Investigation Group Subcommittee will be developing guidance for Designated Individuals on how they can oversee practice by implementing audit against the standards specdified in College guidance, which might then be used to provide assurance to the HTA on inspections. The College publishes a series of audit tremplates and this is anticipated to be part of that document set. 14. Update on ACTION 9: action completed. CBr completed a mapping of HTA standards against RCPath guidance on Coroners post mortem examinations. JL suggested, as this is such a useful resource, that it be made available to Designated Individuals on the HTA website. Item 3 HTA update 15. HTA updates were provided as follows: i. DH Review of human tissue legislation: AC updated the Group on the Department of Health s (DH) consultation on the review of human tissue legislation. Despite support from many stakeholders (including the HTA), the DH will not be making changes to regulations relating to removal of tissue for research and approval of living donations. There will be no public consultation during this Parliament on possible changes to the Human Tissue Act. ii. HTA Members: AC updated the Group on the five new Members of the Human Tissue Authority. Biographies of the Members can be found on the HTA website. iii. HTA Stakeholder Group: AC updated the Group on the meeting of the HTA Stakeholder Group meeting on 23 October Items discussed included a paper from Jim Lowe about the role of the DI and challenges in the post mortem sector, the 3

4 Regulators' Code, the HTA Licencing and Inspection Review and Licence Fees for 2015/16. iv. Disposal of fetal remains: the HTA has been working closely with key stakeholders, including the Department of Health, to develop new guidance on the disposal of fetal remains. Good progress has been made. Some detailed issues still require further work before the revised guidance is ready and a date for publication set. The HTA needs to consider whether incidents relating to pregnancy remains should be included within the HTA-RI system, and CBr will be liaising with HWG members about this in the forthcoming weeks. 16. MO raised concerns about the practical implications of obtaining consent for disposal of pregnancy remains, given the large numbers involved. He stressed the need for there to be advice for staff to support them as they implement the new guidance and asked for clarity on the responsibility of the Designated Individual in ensuring that the guidance is followed. CBr reported that RCN will be bringing its guidance into line with that of the HTA, which will provide more direct advice to clinical teams, but assured the Group that advice for DIs would also be available. The Group discussed whether the RCOG or RCN should be invited to be represented at HWG to provide advice in relation to pregnancy remains, but it was agreed that representatives can be invited to attend as needed. Item 4 RCPath update 17. JL provided updates as follows: i. Advice from the Chief Coroner on the use of imaging: the president of RCPath has written to the Chief Coroner expressing concern about the use of imaging in Coroners post-mortem examinations, particularly in relation to the expectations of families. It is understood that some families may be being provided with information that may lead them to believe imaging will be an option in their case, and that it is completely non invasive, whereas it may be mimimally invasive. In some jurisdictions, imaging is not available; in addition, where imaging is used, families may be under the impression that it may negate the need for a post-mortem examination, which is often not the case. ii. DW stressed that the MoJ s Guide to coroners services makes it clear that where CT (computerised tomography) scanning or MRI (magnetic resonance imaging) are available, it is the Coroner who decides if a scanning technique is appropriate, depending on the circumstances of the death, and where a scanning technique is used, the family or other next of kin may be required to pay a fee. The use of a scanning technique may not avoid the need for a full post-mortem examination if the 4

5 scan does not identify the cause of death. JA pointed out, for the record, that imaging alone would never be used in suspicious death cases. ACTION 1: CBr, with assistance from DW, to provide information for the public on imaging and links to other guidance already available; MoJ guidance to be distributed with the minutes. iii. RCPath guidance on post-mortem examination in suspected Ebola cases: JL brought to the Group s attention new RCPath guidance, based on advice provided by Public Health England, that post-mortems examinations should not be conducted on suspected Ebola cases. The next HTA newsletter will include reference to the guidance, a link to which will be included on the HTA Website. JA stated that the Home Office s position in relation to suspicious deaths reflects RCPath s guidance. iv. RCPath s response to Regulation 28 report from the Surrey Coroner in relation to investigation of death linked to a missed diagnosis of Addison s disease: concern had been expressed as to the adequacy of post mortem investigation in such cases. The College had responded noting that this can be a difficult diagnosis to establish in life and that further review would be made to provide future guidance to pathologists. JL suggested that RCPath s guidance on when to take histology may assist. It was noted that some pathologists may not follow College guidance even when it was available. DW recommended that, as the Coroner determines the work of the pathologist, there should be a memorandum of understanding between the Coroner and the pathologist, which should include details of some form of appraisal by the Coroner of the pathologist s performance. v. RCPath s response to Regulation 28 report from Inner North London Coroner in relation to investigation of deaths involving therapeutic use of medical devices: an issue had been raised relating to a pathologist who had not thought it necessary to preserve a medical device for examination as part of their investigation into the cause of death. The College had responded that a major issue was the provision of adequate clinical information to pathologists in relation to circumstances surrounding the cause of death. MO reiterated that a pathologist cannot be expected to act on information they do not have at the time of the post-mortem examination. Guidance is being prepared for pathologists by the College and will go to the College Fellows for consultation. ACTION 2: JL to distribute RCPath guidance on Implanted Medical Devices to the Group once it had been subject to consultation. 5

6 Item 5 Format of post-mortem reports 18. The HTA had received an from the Bereavement Advice Centre asking whether post-mortem examination reports could include a short lay/plain English summary of the findings, which could be offered to the person who gave consent for the post mortem to be undertaken or, in Coroners cases, to the next of kin. It was suggested that hospital Bereavement Services might facilitiate this. 19. The Group acknowledged that RCPath encourages the use of Plan English in post mortem reports, so that they are accessible to any lay person who needs or wishes to access them. There was some concern that if reports included a lay summary, there may be an increased risk of misinterpretation rather than greater clarity for families, and they stressed the importance of making sure that families have access to a clinician who can take them through any aspects of the findings that need explanation and of the role of the GP in helping families understand the results of a post-mortem examination. They also thought it important to include a definition in brackets after each medical term. 20. In relation to paediatric post-mortem examinations, MA explained that reports usually include a clause stating that they should not be read by parents on their own and without the presence of a person with medical training. ACTION 3: CBr to write to the Bereavement Advice Centre responding to their suggestion Item 6 Consent for disposal of PM tissue following a Coroner s post-mortem examination 21. JL made HTA aware of an anecdotal report from a bereavement officer acting as the Nominated Person (as recommended in our code of practice on PM), who is concerned about how informed families are when they choose to dispose of histological material following a Coroner s enquiry. In this particular case, the deceased had died from an industrial-related illness and the family, through the Coroner, requested that the tissue samples be disposed of by lawful means. The bereavement officer, realising that a medico-legal claim might ensue, contacted the family and explained the potential value to them of keeping the tissue, which they subsequently decided to do. 22. CBr asked the Group, what, if anything, might the HTA do to help ensure families are fully informed about any possible benefits of keeping tissue samples before they decide to have it disposed of. 23. DW advised that there is guidance on disposal of tissue samples on the Chief Coroner s website and pointed out that Coroners Officers, when advising families, need to be careful not to prejudice any legal claim. The Group agreed that the matter of tissue retention, or disposal, is one for the family, who needs as much information as possible 6

7 in order to make informed choices. CBr reminded the Group that the HTA Codes of practice on post mortem examination and disposal gives advice on the options available to families. 24. MO explained that because of the different requirements of the Coroners Act and the Human Tissue Act, consent provided by the family may not meet statutory requirements. CBr emphasised that the Desiginated Individual of the licensed establishment holding the tissue should ensure that, if consent is given for its retention, it has been given by the highest ranking person in the hierarchy of qualifying relationships. She acknowledged that the person with whom the Coroner has liaised is not necessarily the appropriate person to give consent under the HT Act. MO was concerned that, because of the potential difficulties, valuable tissue is being disposed of. SB suggested that the matter would not be resolved in the meeting and suggested it be considered by the HTA and included as an agenda item at the next meeting of the HWG. ACTION 4: DW to advice from the Chief Coroner for CBr to circulate to the Group. Item 7 Horizon scanning: likely changes to the delivery of PM services that might affect HTA s regulatory approach 25. AC asked the Group for their thoughts on sector developments which may affect the work of the HTA, for example, the increase of pathology networks which centralise the provision of services. 26. DJ suggested that the findings of the review of forensic pathology currently being undertaken by Professor Peter Hutton might have more far-reaching consequences for histopatholgy as a whole, with the potential for greater centralisation of services. 27. CBr asked the Group for their thoughts on the new death certification process and the role of Medical Examiners, in particular whether there might be a reduction in the number of PMs as a result. JL felt that the Medical Examiner role will likely result in fewer but more in-depth post mortem examinations. However, MO suggested that the evidence from the pilot studies is inconclusive as to how the numer of coronial PM examinations may alter following nationwide rollout of the medical examiner system. 28. DW offered to provide the Group with the results of a questionnaire undertaken by the Coroners Society about Coroners practices. ACTION 5: CBr to share information from DW with the Group. 7

8 Item 8 Any other business 29. JP asked the Group whether they considered marking bodies with identification details was considered an acceptable practice. The Group agreed that it was not, and an action was agreed for CBr to give guidance to DIs on this topic through the HTA s e-newsletter. ACTION 6: CBr to include an item on the marking of bodies in the next HTA e-newsletter 30. CBr informed the Group that Sharmila Nebhrajani, the new Authority Chair, has asked for greater clarity on how appointments are made to HTA Committees and Advisory Groups and the terms of office involved. Sharmila feels there is a lack of clarity and transparency in the current Terms of Reference for Authority Members, external members, the executive and stakeholders who may refer to them. As a result, a full review of the Terms of Reference for HTA Committees, including the Histopathology Working Group, has been undertaken and a decision made to update the Terms of Reference to improve consistency, add clarity to membership terms and add version control to ensure regular future review. Review of the Terms of Reference also provided an opportunity to establish the boundaries between different Groups and their reporting requirements to the full Authority. 31. The draft ToRs for the three Advisory Groups (the HWG, Transplant Advisory Group and Stakeholder Group) contain sections on recruitment, membership and reporting requirements which are consistent across all the Groups, as well as details of each Group s individual constitution and functions. The Authority will review these at their Strategic Away Day on 28 October. The Groups are likely be asked to endorse their revised Terms at their first meeting after the Authority meeting on 27 January 2015, which for the HWG will be the following March. A draft set for the HWG will be sent to Members well in advance. 32. CBr updated the Group on the HTA s plan to hold two workshops for DIs in the PM Sector in March The HTA will be putting the programme together in the next few weeks and suggestions for topics are welcomed. 33. The meeting closed. CBr thanked members for the attendance and contributions. The next HWG meeting will take place in March AS will circulate potential dates to members. 8