HM Inspector of Anatomy for Scotland: annual report April 2019 - March 2021

HM Inspector of Anatomy: Annual Report - April 1st 2019 - March 31st 2021

Introduction

1. The remit of Her Majesty's Inspector of Anatomy is laid out in Section 9, sub-section 2 of the Anatomy Act 1984 as Amended by the Human Tissue (Scotland) Act 2006 and states:

An inspector shall be appointed -

• to advise the ministers on the exercise of his functions under this Act;
• to inspect premises in respect of which licenses are sought under Section 3(1) of the Act in order to ascertain whether the premises are suitable;
• to examine applications for licenses under the Act in order to ascertain whether the applicants are suitable;
• to inspect premises, in order to ascertain whether any offence has been or is being committed under Section 11(1) or (2) or against regulations under Section 8 (as mentioned in Section 11 (4)).

Inspections

2. The last inspection report covered the period August 2018 - October 2019. However, in order to standardise the period over which each report covers, it was decided to make the annual report run from the 1st April - 31st March for any particular year. This would enable data to be compared from one year to the next.

3. Because of the COVID-19 pandemic, no in-person annual inspections could be carried out for the period 1st April 2019 - 31st March 2020 and consequently no report submitted. Therefore, the brief overlap between this report and the previous report (during April 2019 - October 2019) is acknowledged, and has been used to adjust the timing of these reports to an April - March cycle.

4. Additionally, as restrictions were still in place for the greater part of 1st April 2020 - 31st March 2021, it was decided to carry out a significantly reduced inspection of all licensed areas to cover the entire period from 1st April 2019 - 31st March 2021. This was undertaken during May/June 2021 just as restrictions were starting to ease.

5. In the past, an inspection involved meeting numerous members of staff, a walk around the licensed area and the checking of records against material in storage. On this occasion it only involved the Head of Department plus the minimum number of key staff, however, it did not involve a walk around any of the licensed areas.

6. In normal circumstances, there are 10 licensed areas to be inspected, these being:

• Department of Anatomy, University of Aberdeen
• Dundee:
  • Centre of Anatomy and Human Identification (CAHID), University of Dundee
  • Dundee Institute for Healthcare Simulation Surgical Skills Centre (DIHS), Ninewells Hospital
  • Institute for Medical Science and Technology (IMSaT), Ninewells Hospital
  • ENT Temporal Bone Laboratory, Ninewells Hospital
• Department of Anatomy, University of Edinburgh
• Royal College of Surgeons of Edinburgh (RCSE)
• Department of Anatomy, University of Glasgow
• Royal College of Physicians and Surgeons of Glasgow (RCPSG)
• Department of Anatomy, University of St Andrews

Effects of the COVID-19 Pandemic

7. Prior to the initial lockdown in March 2020, all teaching progressed as normal both at undergraduate (primarily University Medical Schools) and postgraduate (primarily Colleges of Surgeons) levels. Likewise, the body donor programme functioned normally with most anatomy departments receiving as many bodies as was needed to meet their requirements.

8. After the introduction of the March 2020 lockdown, and until summer 2021, all departments suspended face-to-face teaching as well as suspended the body donor program which had a serious impact on teaching at both undergraduate and postgraduate levels. Whereas undergraduate teaching could continue in a limited way with online lectures, lack of cadaver teaching had a significant impact on surgical training and examinations at the Colleges of Surgeons. This prompted a Joint Colleges response from all four Royal Colleges, under the direction of Mr. Ian Colquhoun (RCPSG) to find a safe way forwards for the restoration of face-to-face surgical training using cadavers. Since the writing of this document and since the restarting of face-to-face teaching in the summer of 2021, surgical training using cadaver material has resumed, as has surgical examinations. In order to address the backlog of those waiting to be examined, all Colleges have introduced extra examination diets.

9. More generally, as the risk of accepting potentially COVID-19 infected bodies into an anatomy department was largely unknown, there was a distinct reluctance for departments to accept bodies. There was no overall consensus as to when it was safe to start accepting with each medical school applying its own criteria when it came to accepting bodies. In some cases, like Aberdeen, it was left to the Head of Department, but in others, like Edinburgh, it was the Health & Safety department who decided when it was safe to start accepting.

10. As it was also unknown what effects embalming had on the virus, it was decided by anatomists throughout the UK, led by anatomists in Scotland's anatomy schools, to investigate this. As a consequence, funding has been secured and there is currently an ongoing investigation into the effects of embalming on the virus.

11. The current situation with regards to face-to-face teaching and the body donor programme for each medical school is referred to in the corresponding report.

12. It is assumed that full inspections will resume in 2022 but this will very much depend on the situation with COVID-19 at the time.

Summary of Outcome of Inspections

Aberdeen (Date of Visit: 16 June 2021)

13. Head of Anatomy: Professor Simon Parson

14. Due to the reduced nature of the inspection, records could not be checked against bodies in storage or parts retained. Following on from a recommendation after the last inspection that a less complicated, more user-friendly record keeping system be considered, a more up-to-date bespoke record system is being developed and should be in place by the time of the next inspection.

15. At the time of the Inspection (June 2021) the body donor programme was still suspended but this was going to be reviewed in the near future. It was hoped to restart some face-to-face teaching should social distancing be reduced to 1m which would entail smaller class sizes with more rotations. At that time there was no confirmed date as to when the body donor programme would restart but it was anticipated that it would be in the very near future.

16. A comprehensive handout was made available summarising all the required data for the inspection plus a list of all courses run by the department. These include undergraduate courses for science and medical students and postgraduate continuing professional development courses for those working in medicine or those in professions allied to medicine.

Data for the period 1st April 2019 - 31st March 2021:

Bequest Forms requested	318
Bequest Forms returned	193
Bodies accepted	40
Bodies rejected	22
Bodies redirected to another department	11
Redirected bequests accepted	0
Number of embalmed bodies currently held	32
Number of frozen bodies in storage	11

Response to the Pandemic:

17. On the day of the visit, all face-to-face teaching was suspended as was the body donor programme. Body donations were being redirected to other medical schools.

18. The body donor programme restarted in August 2021 and face-to-face teaching restarted in September.

Dundee

Centre of Anatomy and Human Identification (CAHID), University of Dundee (Date of Visit: 31 May 2021)

19. Head of Anatomy and Director of the Centre: Professor Tracey Wilkinson.

20. A premises license was available for inspection as was a map of the licensed areas within the department. Plans for an extension to the body storage facility were available for viewing as was the area itself. As it is an extension to what is already a licensed area, assurances were sought and given by the building contractor to the Head of Department that at no time would anyone have access to the licensed area during the construction work, i.e. the licensed area would be secure at all times. On completion, this would increase the body storage capacity from 200 at present to 216. At the time of the inspection, work had yet to start; on completion of the work, it will be necessary to visit to confirm its suitability before granting a new premises license

21. A comprehensive folder containing all relevant records and copies of all paperwork, which are kept in a locked, fireproof cabinet and offsite on a secure server, was made available. However, a cross check of the records with retained parts etc. could not be carried out due to the restricted nature of this inspection.

22. CAHID receives all bodies for embalming which are then distributed to other licensed sites as required. All bodies are embalmed using the Thiel method; there are no frozen bodies on site.

23. At the time of the inspection, CAHID was responsible for 139 bodies, 13 of which were offsite. These are used for a variety of medical/dental/medically related undergraduate courses. There is also an extensive use of bodies by external courses for both medical education and research.

Dundee Institute for Healthcare Simulation Surgical Skills Centre (DIHS), Ninewells Hospital

24. This area was not visited; all information for licensed areas in Dundee were provided by CAHID.

25. At the time of reporting, 10 bodies were on site all of which are under the control of CAHID. Bodies are usually stored at CAHID and transported to the Skills Centre when needed where they may be kept for short periods.

26. All body movements between CAHID and the Skills Centre are tracked on the CAHID database.

Institute for Medical Sciences and Technology (IMSaT), Ninewells Hospital

27. This area was not visited.

28. At the time of reporting there were 3 bodies being kept onsite which were used as and when required for research projects. As for DIHS, all bodies used by IMSaT are under the control of CAHID with all body movements between the two sites being tracked on the CAHID database.

ENT Temporal Bone Lab, Ninewells Hospital

29. This area was not visited.

30. At the last inspection, it was noted that there was no door between the bone lab and the adjacent office where temporal bones were stored which allowed, potentially, unrestricted access to the licensed space. A request was made that a secure door be fitted between the office and the bone lab. This work was duly carried out, subsequently inspected and found to be more than adequate for its purpose.

31. All material held in the bone lab is under the control of CAHID and is recorded on their database.

Data for the period 1st April 2019 - 31st March 2021:

Bequest Forms requested	622
Bequest Forms returned	319
Bodies accepted	103
Bodies rejected	80
Bodies redirected to another department	7
Redirected bequests accepted	17
Number of embalmed bodies currently held on all sites	139
Number of frozen bodies in storage	0

Response to the Pandemic:

32. Face-to-face teaching was in place throughout most of the lockdown but with a reduced practical element; a COVID 19 Health & Safety policy (made available for inspection) was in place to allow this to happen. The body donor programme ran, with only minor disruption, throughout the time of the pandemic. Again, mitigations were in place to allow this to happen safely.

General Comments:

33. Significant staff changes were reported with the imminent departure of 2 technical and 2 academic staff. It is hoped to make new appointments quickly as the work load for the remaining staff is going to increase significantly with their departure.

Edinburgh (Date of visit: 26 May 2021)

34. Head of Anatomy: Professor Tom Gillingwater

35. A comprehensive booklet containing all the relevant information required for an inspection was made available although, as was the case elsewhere, a check was not made of checking the records against bodies/body parts retained. Because of the different levels of access to licensed areas, also included in the booklet was a comprehensive list of all those having access to specific areas. I was happy with the way this was controlled by the lab manager.

36. A comprehensive record keeping system is in place which is held as a paper copy locally in the department but also backed up on a server. At the last inspection (2018 - 2019) a recommendation was made that all paper copies of records should be stored in a fireproof cabinet. This has now been implemented.

37. For the greater part of the period for which this report covers, no bodies or body parts were transferred between the anatomy department and the College of Surgeons of Edinburgh for courses run by the College.

38. At the time of the inspection, there were 19 embalmed and 45 frozen bodies on site.

Response to the Pandemic:

39. At the time of inspection, courses continued to be run online. No face-to-face teaching took place throughout the duration of the lockdown, however, this has re-commenced recently but with significantly reduced class sizes. Likewise, the body donor programme was also suspended for the duration of the lockdown but this has also now recommenced.

General Comments:

40. At the last inspection, it was evident that the embalming and body storage facilities at Edinburgh were in need of upgrading. This is now being addressed by the University with refurbishment of the area expected to start before the end of the current year.

Data for the period 1st April 2019 - 31st March 2021:

Bequest Forms requested	625
Bequest Forms returned	401
Bodies accepted	35
Bodies rejected	139
Bodies redirected to another department	26
Redirected bequests accepted	0
Number of embalmed bodies currently held	19
Number of frozen bodies in storage	45

Royal College of Surgeons of Edinburgh

41. This area was not visited. Information was obtained by a telephone conversation with the Skills Centre Manager.

42. Skills Centre Manager: Lynsey Forbes

43. At the time of the last report, the Skills Centre Manager was the only licensed teacher and the only member of staff looking after the lab facilities. Since then, 2 new members of staff have been appointed.

44. Also, at the time of the last report, although access to the licensed area was locked, the door to the area was not alarmed and hence could be left opened inadvertently; this was also true for doors at the back of the lab. All doors now have alarms fitted such that, should one be left open, an audible alarm is sounded and a visual alarm triggered in the Skills Centre office.

Response to the Pandemic:

45. Most courses using cadaver material were suspended. Specimen usage documents were provided and covered the period of April 2019-March 2020 and April 2020-March 2021.

46. Most bodies/body parts for courses are obtained from the Anatomy Department of the University. Records are kept of all material received from the University which is signed for on receipt; it is also signed for on its return to the University.

47. Alternative sources of bodies/body parts are:

• Centre for Anatomy and Human Identification, University of Dundee
• National Repository Centre, Nottingham University Hospitals
• Science Care, USA

48. Bodies/body parts obtained from UK sites are returned to source following course/event. For specimens obtained from Science Care, arrangements are made for cremation at Borders Crematorium, Melrose.

Glasgow (Date of Visit: 25 May 2021)

49. Head of Anatomy: This post is currently vacant but is expected to be filled in the near future. Professor Simon Guild, Head of the School of Life Sciences is currently acting up as Head of Anatomy until this post is filled.

50. Since the last inspection (2018 - 2019) a new intruder alarm system has been installed which is a major upgrade to the previous system.

51. The public don't have access at the moment to the museum due to current COVID-19 related circumstances.

52. Room 208 adjacent to the museum was inspected with a view to it becoming licensed in due course. An application for this room to be licensed has yet to be received.

53. A comprehensive record keeping system is in place with all records being kept both locally in a locked fireproof cabinet and on a secure server. Additionally, they have in place a printed and bound standard operating procedure for the handling of cadavers from the receipt of a body into the department until its final disposal by cremation.

54. A list of all courses using cadaveric material was provided. External courses are organised by the Clinical Anatomy Skills Centre (CASC) which is a joint venture between the University of Glasgow and the Royal College of Physicians and Surgeons of Glasgow. A Joint Management Committee which vets all courses before allowing them to go ahead manages these. A total of 47 courses were organised jointly between the University of Glasgow and the Royal College of Physicians and Surgeons of Glasgow for the period of this report, the majority of which had to be cancelled due to the pandemic.

55. At the time of the inspection, there were 98 bodies on the premises, 53 of which were embalmed and 45 frozen. All the historic, non-tagged retained parts which were in the department at the last inspection have now been disposed of.

Response to the Pandemic:

56. Face-to-face teaching was suspended from the start of the initial lockdown as was the body donor programme, the latter which restarted on 17th May 2021. All bodies accepted are PCR tested on arrival the results of which are available within 24 hours of testing. All families are told of this and of the possibility of the body being returned to them in the evet that a test proves positive.

Data for the period 1st April 2019 - 31st March 2021:

Bequest Forms requested	~300
Bequest Forms returned	390
Bodies accepted	57
Bodies rejected	116
Bodies redirected to another department	8
Redirected bequests accepted	10
Number of embalmed bodies currently held	53
Number of frozen bodies in storage	45

Royal College of Physicians and Surgeons of Glasgow

57. This area was not visited.

58. Director of Clinical Skills: Mr. Ian Colquhoun

59. All requests for cadaveric material from the Anatomy Department, University of Glasgow are emailed to a licensed teacher who then logs the specimens out of the department and logs them back in on their return. When anatomical material is present within the Royal College it is documented, logged and stored within the electronically monitored cadaveric store.

60. No anatomical material from sources other than the Department of Anatomy, University of Glasgow has been used within the last year.

61. A list of all courses organized by the College within the Clinical Anatomy Skills Centre based in the Thomson Building at the University of Glasgow was included in the information provided by the Department of Anatomy, University of Glasgow. Many of these courses were cancelled as a result of the pandemic.

St Andrews (Date of Visit: 7 June 2021)

62. Head of Anatomy: Dr Enis Cezayirli

63. A user friendly, computer-based record keeping system is in place which is first class in its operation. Access to the system is by licensed teachers, the bequest coordinator and IT staff who maintain the system.

64. There were 41 bodies in the department at the time of the inspection all embalmed; no frozen bodies are used although the facility exists to do so.

Response to the Pandemic:

65. Face-to-face teaching was suspended between March and April 2020. Face-to-face teaching resumed in academic year 2020/21 with reduced number of students, wearing full PPE.

General Comments:

66. At the time of the visit, there were only two full-time licensed teaching staff, one lecturer and one technician who acts up as a teaching fellow. The Chair of Anatomy at St Andrews has been vacant now for several years although the University are now actively seeking to fill this position. This is by far the smallest and most junior staff complement of any medical school in Scotland; someone with the responsibilities of head of a department is invariably, at the very least, senior lecturer level.

67. These two teaching staff members are to be commended for managing to maintain a high standard of teaching in what would be, in normal times, extremely difficult circumstances. Add to this the impact of the pandemic then their efforts are particularly commendable.

Data for the period 1st April 2019 - 31st March 2021:

Bequest Forms requested	118
Bequest Forms returned	59
Bodies accepted	41
Bodies rejected	39
Bodies redirected to another department	0
Redirected bequests accepted	14
Number of embalmed bodies currently held	41
Number of frozen bodies in storage	0

General Points

Impact of the Pandemic

68. No random checks of records against retained bodies/body parts were possible due to ongoing COVID-19 restrictions, however, copies of all records held were made available for inspection. All departments have to be commended in the amount of information made available for inspection. These included copies of information packs sent out to all potential donors, copies of personal licenses held, copies and plans of licensed premised, lists of courses run in each department and much more besides. This is significantly more information than was ever made available in the past.

69. Despite the suspension of the body donor programme, all departments had sufficient bodies in storage to meet their needs for when face-to-face teaching restarted. The biggest impact of the suspension of the donor programme was less on undergraduate teaching in university medical schools but more on postgraduate surgical training courses run by the two Scottish Colleges of Surgeons with most, if not all, courses requiring access to bodies/body parts having been cancelled.

70. As part of the Government's COVID-19 emergency measures, there was a suspension on the requirement for all bodies to be disposed of within the 3-year statutory limit from the time of receipt of a body. No department, however, required this extension as all bodies, whose disposal dates fell during the period of the extension, were all disposed of in advance of the introduction of this measure. This suspension has now been lifted, and the 3-year statutory limit has been reinstated.

Premises Licenses

71. Premises licenses plus maps of licensed areas were available for inspection from all departments all of which were in date.

Incidents

72. There were no recorded incidents requiring my intervention at any time since the last inspection.

Memorial Services

73. All medical schools have a memorial service at some point in the year to which relatives and friends of all those who donated their body for medical education and the advancement of medical science, are invited. These are all different in their presentation but all serve the same purpose and all are typically very well received by those attending.

74. Given the inability of medical schools to conduct their typical memorial service for body donors during the COVID-19 pandemic, with the exception of Edinburgh, all medical schools conducted an online memorial service which were very well produced and very well received.

Code of Practice

75. The revised draft Code of Practice is still currently going through its final revision, having been delayed as a result of the pandemic, and will be in its final working form in the near future.

Disposal of Plastinated Material

76. Without exception, all departments are starting to accumulate no longer required, plastinated material. Plastinated material is human tissue that has undergone a process whereby the tissue fluids have been replaced by a silicone resin rendering the material rubber like in texture. The problem arises when it comes to the disposal of this material as crematoria are not willing to accept it due to the potential toxic fumes that may be given off during the cremation process and it is not clear if burial is an option. To get advice on this, the Scottish Environment Protection Agency (SEPA) has been contacted and is now looking into this. As there has still been no response since this advice was sought back in 2019, this needs to be followed up.

External Courses

77. In order to address concerns that had been expressed over external courses that had run in the past, a meeting was held with Heads of Anatomy and other relevant staff to discuss the criteria which external courses had to meet before they could be considered for access to anatomy facilities and to cadaver material in particular.

78. To summarise the outcome of this meeting:

• access to bodies/body parts must not be used to promote a course or to make money from a course;
• information to donors should be comprehensive in its description on how bodies are used;
• affiliation to a professional body was not felt appropriate as it would be too restrictive;
• it was felt that the decision as to whether a course should run or not was ultimately up to the Head of Anatomy and their corresponding institution but that at all times, due diligence should be applied; and
• at all times, the requirements of the Code of Practice had to be observed.

Induction Programme for Applicants for a Personal License

79. Until now, anyone applying for a Personal License only had to get the support of their Head of department without necessarily having any insight of what having a license involves and the responsibilities that go with having a license.

80. Consequently, it was decided to introduce an induction programme, which would be freely available to anyone wishing to become a Personal License holder. This is currently being developed under the direction of Professor Paul Rea, Department of Anatomy, University of Glasgow and myself, with input from the Scottish Government.

81. This is long overdue and will help to formalise the license application process. It is anticipated that individual anatomy schools will require anyone applying to be a Personal License holder within their school to first undertake this course. This will not be a statutory requirement, as it is not provided for in legislation.

Other Activities

82. These include:

• reviewing license applications, both personal and premises, before issuing them. In the case of the latter, it invariably means visiting the premises in question to make sure that it conforms to the requirements of the Act and the Code of Practice.
• responding on a day-to-day basis to email and telephone enquiries both from licensed teachers and members of the public on a wide and varied range of anatomically related topics.
• Attending body donor programme bequest coordinator meetings. While these six-monthly meetings were paused during the COVID-19 pandemic, a meeting was held in February 2021.
• Attending the Scottish Public Serviceman's Ombudsman complaints investigation skills training on 9 June 2021, 15 June 2021 and 17 June 2021.

Data Summary (cumulative figures for all Anatomy Departments from 1st April 2019 - 31st March 2021):

Bequest Forms requested	1983
Bequest Forms returned	1362
Bodies accepted	276
Bodies rejected	396
Bodies redirected to another department	52
Redirected bequests accepted	41
Number of embalmed bodies currently held	284
Number of frozen bodies in storage	101

Conclusion

83. Despite the significantly reduced inspection, it is evident all departments are functioning well and conforming to the requirements of the Anatomy Act 1984 as Amended by the Human Tissue (Scotland) Act 2006.

84. There is no doubt that medical education at both undergraduate and postgraduate level has been seriously impacted by the pandemic and there was concern that the body donor programme would have problems restarting after such a long period of suspension. However, given the number of enquiries received from across Scotland for information about the body donor programme and the number of body donations being received since the resumption of the donor programme, it indicates that despite the difficulties of the last 18 months, anatomy in Scotland and consequently medical education looks set to quickly return to pre-pandemic levels.

Gordon Findlater

5^th October 2021

Her Majesty's Inspector of Anatomy for Scotland