Mr Nicos A Kafkarkou

Profession: Biomedical scientist

Registration Number: BS23054

Hearing Type: Final Hearing

Date and Time of hearing: 10:00 20/05/2019 End: 17:00 12/06/2019

Location: Health and Care Professions Tribunal Service, 405 Kennington Road, London, SE11 4PT

Panel: Conduct and Competence Committee
Outcome: Not well founded

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Allegation

During the course of your employment as Head Biomedical Scientist for Haematology and Blood Transfusion at North Middlesex University Hospital:

1. Between the MHRA inspection on 27 November 2007 and December 2015, you did not ensure that areas of concern were adequately addressed, in particular:

  1. You did not ensure there were adequate systems in place to prevent untrained staff accessing fridges containing blood;
  2. You did not ensure that recall procedures were being adequately maintained and/or followed.

2. You did not ensure, and/or make a record of ensuring that the Biomedical Scientist who issued 3 units of incompatible blood in around March 2015 was adequately retrained.

3. You did not ensure that there was a Standard Operating Procedure in respect of the secondary monitoring system in relation to refrigeration, until prompted.

4. Between July 2011 and December 2015 you did not ensure that staff were adequately trained and/or competent to work in the blood transfusion service.

5. The matters set out in paragraphs 1 - 4 constitute misconduct and/or lack of competence.

6. By reason of your misconduct and/or lack of competence your fitness to practice is impaired

Finding

Preliminary matters

Joinder of Allegations

1. On 26 July 2018 a panel of the Conduct and Competence Committee decided that the allegations in the cases against Mr Nicos Kafkarkou (‘NK’) and Mr Oodish K Dahal, who is known as ‘Anil’ Dahal (‘AD’) be joined.

Service and Proceeding in Absence (Mr Dahal)

2. AD did not attend the hearing and was not represented. The Panel decided that the Notice of Hearing dated 15 January 2019 had been sent on that date by first class post to his registered address. The Legal Assessor advised that service of the notice complied with rules 3 and 6 of the Health and Care Professions Council (Conduct and Competence Committee) (Procedure) Rules 2003 as amended (‘the Rules’). The Panel accepted that advice and decided that there had been good service of the Notice of Hearing.

3. Mr Dite submitted that the Panel should proceed with the hearing in the absence of AD. He referred to correspondence passing between AD and the HCPC in May 2018 and in particular to AD’s email of 9 May 2018 in which he stated, ‘ .. I won’t be contesting the allegations do what you need to do.’ Mr Dite submitted that it was clear that AD had chosen not to attend the hearing and that in the circumstances, the hearing should proceed in his absence.

4. The Panel directed itself in accordance with advice given by the Legal Assessor, who referred to the terms of rule 11 of the Rules, the principles from Adeogba v GMC [2016] EWCA Civ. 162 identified in the HCPTS’ Practice Note, Proceeding in the Absence of the Registrant, September 2018 and a passage from the judgment in Davies v HCPC [2016] EWHC 1593 (Admin) at [19].

5. The Panel was satisfied that all reasonable steps had been taken to serve the Notice of Hearing on AD in accordance with the Rules and that he had chosen both not to attend the hearing and not to be represented. The Panel took into account the public interest in the prompt disposal of these proceedings and the effect of any delay on the memories of the five witnesses who were due to attend. There was no reason to believe that an adjournment would secure the attendance of AD at a later date. In those circumstances, the Panel decided that it would be fair to proceed in the absence of AD and decided to do so.    

The HCPC’s case against Mr Kafkarkou and Mr Dahal

Background

6. The joined cases arose out of a Serious Untoward Incident (‘SUI’) that occurred at North Middlesex University College Hospital (‘NMUH’ or ‘the Hospital’) on 30 March 2015. The incident concerned the issue of three units of incompatible blood to a patient with Sickle Cell disease by a Biomedical Scientist (‘BMS A’).

7. In April 2015 Health Services Laboratories (‘HSL’) took over management of all pathology services at NMUH. This change was not connected to the SUI.

8. An investigation into the SUI was undertaken by KM, who was the Transfusion Practitioner at NMUH and by Dr R-H, a Consultant Haematologist at the Hospital. Their report dated June 2015 identified the root cause of the SUI as follows, -

‘The Laboratory Information Management System (LIMS) … permitted three units of B RH D Negative red blood cells to be issued to a patient who was O RH D Positive. Correct implementation of electronic issue via the LIMS could have prevented the allocation and administration of the incompatible blood to the patient. The ISOFT MGXR notification document had been received by this hospital but an inadequate implementation process for software upgrades was found to be the root cause within the BT laboratory…..’   

9. PF, a self-employed Quality Advisor engaged by HSL, undertook two audits of the Blood Transfusion Laboratory (‘BTL’). The first one took place on 10 and 16 April 2015 and was part of a wider audit carried out by him for HSL to review compliance with quality standards in various departments of the Hospital. The second audit, on 2 and 4 September 2015, examined particular areas in more depth. PF set out his conclusions from that audit in a report dated 7 September 2015 (‘the Second Report’). 

10. As a result of some adverse findings made by PF in the Second Report, HSL commissioned a mock regulatory ‘MHRA’ inspection and report from an external consultant. MHRA is the acronym of the regulator, the Medicines and Healthcare products Regulatory Agency.

11. On 7 October 2015 the mock MHRA inspection was carried out by SG, who produced a report dated 8 October 2019 (‘the Mock Inspection Report’), that contained findings that were critical of certain procedures in the BTL in particular.     

12. On 27 November 2007 MHRA had carried out a formal on-site regulatory inspection (‘the 2007 MHRA Inspection’). SG was the MHRA inspector. His conclusions were set out in a subsequent written report (‘the MHRA Report’). EC, Blood Transfusion Compliance lead at The Doctors Laboratory Ltd., was instructed to make a comparison between the conclusions from the Mock Inspection Report and those in the MHRA Report.

13. EC concluded that the results of the mock inspection ‘were worryingly similar to those following the 2007 MHRA Inspection.’

14. On 19 October 2015, LB then the Central London Operations Manager with HSL, was appointed to conduct an investigation and on 23 December 2015 she submitted her report. As part of that investigation she interviewed AD, NK and two other persons. One of these was JS, who had been the Quality Manager for the BTL between 2012 and 7 July 2015. The other person interviewed was GB, who had been employed as the Head of Pathology for NMUH prior to 1 April 2015.

15. NK was the Laboratory Manager for Haematology and Phlebotomy at the Hospital. He was responsible for patients who used the Haematology, Blood Transfusion and Phlebotomy services at NMUH and had management responsibility for all scientific and support staff within the Haematology, Blood Transfusion and Phlebotomy departments. GB was his line manager.

16. AD was the Chief Biomedical Scientist in Blood Transfusion at NMUH and  had occupied that post since the early 1990’s at least. His line manager was NK.  

17. Disciplinary proceedings against NK were begun but were ultimately not  pursued by HSL. A disciplinary hearing took place in relation to AD on 12 February 2016 and he was notified of the outcome by letter dated 17 February 2016.

18. NK self-referred to the HCPC on 7 March 2016 and the referral concerning AD was made by KM on 13 October 2015. Her referral concerned two matters in particular, namely –

• ‘The Laboratory Information Management System was incorrectly set up and allowed the issue of incompatible B units …

• A temperature mapping report indicating that a Blood Bank had a significant cold spot had been ignored with no action taken even though evidence was provided that [AD] had been informed.’

Mr Kafkarkou’s Half-Time Submission

19. Mr Dite opened his case on the first day of the hearing and called evidence from the following witnesses in relation to the allegations against both Registrants in this order :

EC - Blood Transfusion Compliance Lead at TDL, registered Biomedical Scientist.

PF -  self-employed Quality Advisor

JS - Principal Quality Manager for HSL;

LB - Former HSL Operations Manager for Central London;

GB -  Former Head of Pathology at NMUH, now retired but   formerly a registered Biomedical Scientist.

20. On the morning of the third day of the hearing Mr Dite closed his case for the HCPC and Mr Polaine made a submission of ‘no case to answer’.

21. He submitted that there was no case to answer in relation to the HCPC’s factual case against NK. The main thrust of his submission was that in respect of each of the factual particulars in paragraphs 1-4 of the allegation, the HCPC had presented either no evidence sufficient to sustain the particulars or the evidence that it had presented was so unsatisfactory in nature that the Panel could not find the particulars proved. He also submitted that in any event the evidence presented was such that, when taken at its highest, no reasonable panel could properly conclude that either statutory ground was met or that NK’s fitness to practise is impaired. Mr Polaine relied on the principles set out in R v Galbraith [1981] 1 WLR 1039 and in the HCPTS’ Practice Note, ‘Half-Time’ Submissions, 22 March 2017. 

22. Mr Dite accepted that the relevant principles were those referred to by Mr Polaine. He submitted that the evidence presented by the HCPC was both sufficient and satisfactory so as to render the HCPC’s case capable of proof. The evidence was capable of establishing both statutory ground and current impaired fitness to practise. The submissions for the parties were also made by reference to the detail of the evidence.

23. The Legal Assessor advised the Panel that the legal principles were those set out in R v Galbraith and the Practice Note and that if the Panel’s decision were the submission of no case to answer failed either wholly or in part (i.e. was in part successful only), the appropriate course would be to defer the giving of reasons until the Panel announced its decision on the issues of fact and statutory ground. The Panel accepted that advice.

24. The Panel announced its decision on the morning of the fifth day. In summary, the decision was that the half-time submission succeeded in respect of paragraph 2 and paragraph 3 in their entirety. The submission succeeded in respect of paragraph 4 on all matters relied on except for one. This left paragraphs 1a, 1b and 4 (so limited) for determination. The following are the reasons for that decision.       

‘1. Between the MHRA inspection on 27 November 2007 and December 2015, you did not ensure that areas of concern were adequately addressed, in particular:

a. You did not ensure there were adequate systems in place to prevent untrained staff accessing fridges containing blood;

b. You did not ensure that recall procedures were being adequately maintained and/or followed.’    

Paragraph 1a

25. The evidence advanced by the HCPC included criticisms in the MHRA Report concerning procedures and systems in place for access to blood laboratory fridges. The results of the Mock Inspection Report included similar concerns.

26. This evidence and the other evidence placed before the Panel for this particular included further matters concerning lack of systems and procedures to restrict access to untrained staff; as set out in EC’s witness statement dated 4 May 2018 in respect of the case against NK paragraphs [20] - [24], PF’s witness statement paragraphs [21] - [27] and relevant exhibits.

27. The evidence placed before the Panel as to the managerial responsibilities of NK was capable of establishing an obligation placed on him to ensure that there were adequate systems in place to prevent untrained staff from accessing fridges containing blood.

28. Therefore, the Panel rejected the submission in respect of paragraph 1a, having also concluded that the evidence if accepted was capable of establishing a statutory ground under paragraph 5.

Paragraph 1b)

29. Paragraphs 32 – 36 of EC’s witness statement dated 4 May 2018 in the case against NK placed a number of matters before the Panel. That evidence indicated that blood recall procedures had been noted as a ‘major’ deficiency in the MHRA Report. The report was exhibited to her witness statement and also a report containing an internal audit of NMUH’s transfusion department of 15 May 2015 (‘the Recall Audit’).

30. EC stated that the Recall Audit found that some recalled products had been transfused by the time the recall requests were made and there was no evidence to suggest that the clinician in charge of the patients or the Consultant Haematologist were informed, as they should have been in view of the relevant Standard Operating Procedure (‘SOP’). Out of the ten recall forms audited, the internal recall form had only been used on one occasion, contrary to the SOP. In addition, recalls were not logged as clinical incidents. There was, she stated, no indication in how timely a manner the recalls had been performed. For these and other reasons, she stated that there had been shortcomings in the recall procedures.

31. The evidence placed before the Panel as to the managerial responsibilities of NK was also capable of establishing an obligation placed on him to ensure that there were adequate systems in place to ensure that recall procedures were being maintained and followed.  

32. The Panel decided that the evidence was capable of establishing this factual particular, which in turn is capable of being sufficiently serious to establish a statutory ground. Therefore, the Panel rejected the submission of no case to answer in respect of paragraph 1b.

‘2. You did not ensure, and/or make a record of ensuring that the Biomedical Scientist who issued 3 units of incompatible blood in around March 2015 was adequately retrained.’

33. The Panel decided that the evidence placed before it was not capable of establishing any of the factual particulars in paragraph 2. The evidence of LB was not capable of establishing that retraining had not taken place. The training records she produced were for periods before 1 April 2015. The retraining was to take place after that date. LB did not interview MA, the Training Officer. The evidence was that he held the training records.

34. GB’s evidence was that the necessary retraining had been undertaken by all staff in relation to the IT matters that caused the SUI, once the new upgrades to LIMS had been installed.  The evidence presented by the HCPC was that this was the only retraining that BMS A required.

35. In view of these insurmountable difficulties with the HCPC’s case, the evidence was not capable of establishing the further conclusion in paragraph 2 that NK had not made a record with respect to the re-training. 

36. Therefore, the evidence was not capable of supporting any of the factual particulars in paragraph 2. There was no case to answer in respect of this particular of the allegation.

‘3. You did not ensure that there was a Standard Operating Procedure in respect of the secondary monitoring system in relation to refrigeration, until prompted.’

37. Secondary monitoring of fridge temperatures is put in place to create an alert if the temperature at which refrigerated blood is stored falls outside the range of 2 – 6 degrees Celsius. 

38. There was evidence that NK’s responsibilities included the writing of a SOP. However, GB accepted that the secondary monitoring system was an ‘enhanced service’, not a requirement. Further, NK did write the SOP after EC had asked him to do so. 
 
39. Therefore, the Panel decided that although the evidence was capable of establishing this factual particular, the facts were not capable of establishing either of the statutory grounds in paragraph 5 of the allegation, not being sufficiently serious in their significance.

‘4. Between July 2011 and December 2015 you did not ensure that staff were adequately trained and/or competent to work in the blood transfusion service.’

40. The evidence for the HCPC in relation to paragraph 4 was to be found in the evidence of LB, PF, GB and JS and in various documents exhibited by them to their witness statements. As a result of LB’s internal investigation following the SUI, she drew certain conclusions as to the inadequacy of the steps taken to ensure that staff were adequately trained and competent to work in the blood transfusion service of NMUH.

41. However, LB did not interview a number of potentially important individuals in her investigation. These included MA (the Training Officer for Blood Transfusion), KM (the Blood Transfusion Practitioner), the deputy to Mr Dahal or the consultant member of the Haematology Transfusion Team (‘HTT’), which team had responsibility for the blood transfusion guidelines and policies in use within the Blood Transfusion Laboratory. Nor did LB seek access to the minutes of the meetings of the HTT. The evidence also showed the existence of a SOP for training and a Training Needs Analysis, neither of which were sought by LB. In addition, LB did not obtain the training records from MA. 

42. GB’s evidence when cross-examined was that all members of staff had been properly trained and JS’s evidence was that they had all been retrained on the necessary updated procedures following the SUI. The enquiries made by PF were limited to two discussions with two members of staff and he stated that he was not in a position to criticise any one person for such shortcomings as he found during his audit.

43. As a result, the evidence produced by the HCPC is, subject to one exception, so unsatisfactory as to be not capable of supporting this particular of the allegation.

44. The exception concerns the matters set out in paragraph 14 of EC’s witness statement dated 4 May 2018 in relation to the case against NK, which contained credible evidence of the matters set out in it. Those matters were as follows, -

‘The [Blood Safety and Quality] Regulations [2005] state that the person responsible for the management of a hospital blood bank should ‘establish and maintain a quality system for the hospital blood bank which is based on the principles of good practice.’ [AD] was the person responsible for implementing the IT System. But I found no evidence that he had been formally trained in that system programming. .. We found no named person in the department who took responsibility as a system manager for the IT system. I found no evidence that [AD] was trained to perform IT programming … I would have expected [NK] as Head of Haematology and Blood Transfusion to ensure key personnel were trained in advanced use of the system or someone to have been designated to have this duty.’           

45. Therefore, in relation to paragraph 4, the Panel decided that the evidence was not capable of establishing any of those factual particulars, with the exception of the matters set out in that paragraph 14. Those matters are capable of establishing each of the two elements in paragraph 4. There was no case to answer as to paragraph 4, with that exception.

Paragraphs 5 and 6 

46. The Panel also decided that a reasonable panel could properly find that NK’s fitness to practise is currently impaired, though not by reference to those matters on which the Panel found there to be no case to answer.  

Decision on Facts: Mr Dahal’s case and the remaining case against Mr Kafkarkou.

The Witnesses for Mr Kafkarkou

47. The Panel heard oral evidence from NK and from the following witnesses, -

KM -  registered Biomedical Scientist and formerly Transfusion Practitioner at NMUH;

Dr AY - retired Consultant Haematologist, formerly at NMUH;

Dr JL -  retired Consultant Haematologist, formerly at NMUH.

Panel’s approach

48. The Panel heard oral submissions from Mr Dite on behalf of the HCPC and from Mr Polaine for NK. Mr Dite properly referred the Panel to matters that might be in AD’s favour on the evidence.

49. The Panel has considered all the evidence, both oral and documentary and has directed itself in accordance with the advice given by the Legal Assessor. The Panel has taken into account statements and opinions set out in documents that were given by persons not called to give oral evidence. In deciding what weight to give to that evidence, it has borne in mind that it was not sworn evidence, was not subject to cross-examination or other questioning and the Panel has also applied the various considerations identified by the Legal Assessor as relevant to those statements.   

50. The HCPC bears the burden of proof and the standard of proof is the balance of probabilities.  In reaching its decision on the factual cases against both NK and AD, the Panel has taken into account all the evidence in the joined cases. However, it has considered separately each particular of the allegations against AD and NK. No inference adverse to AD was drawn by the Panel from his absence.

Panel’s assessment of the witnesses

51. The Panel’s assessment of the witnesses for the HCPC was as follows. EC was open and fair-minded. [redacted]

52. PF was also open and honest. He did his best to assist the Panel. His evidence was, though, undermined to a significant extent because he produced a document that his witness statements stated was a report made by him of the results of his audit in April 2015. It was a different audit report, though it may have included some of the pages from a report he did make. This was an oversight on his part and not more.

53. The Panel considered JS to be an honest, thorough and credible witness. Her evidence was limited in scope. LB tried to be helpful. However, the credibility of her evidence was qualified by the limited scope of her investigation. She did not interview relevant individuals, namely MA, KM, BMS.A, Dr R-H or AD’s deputy.

54. GB was guarded in his evidence. His recollection of events was also unclear on important points.

55. The Panel’s assessment of the witnesses who gave evidence for NK was as follows. NK was a truthful and credible witness and was able to provide important additional information to the Panel. 

56. KM was a compelling witness, clear in her recollections and cogent in her explanations. The credibility of her evidence was not qualified by the fact that AD had made a complaint of bullying against her. When asked about that, she told the Panel that the complaint had been dismissed and it had weighed heavily on her since; it made her anxious about raising concerns she had about AD’s work and which resulted in the referral she made to the HCPC. The Panel accepted her evidence, except for her criticism of AD about the set-up of the LIMS IT system, for the reasons set out later in this decision. 

The Background to the cases against Mr Kafkarkou and Mr Dahal

57. The Panel refers to the matters set out above under the heading of ‘Background’. These set the context of the allegation against both NK and AD. They are uncontroversial and the Panel has found them proved so far as relevant to the allegations against both Registrants.

The Panel’s decision on the remainder of the factual case against Mr Kafkarkou

1. Between the MHRA inspection on 27 November 2007 and December 2015, you did not ensure that areas of concern were adequately addressed, in particular:

a. You did not ensure there were adequate systems in place to prevent untrained staff accessing fridges containing blood;’

58. Following the 2007 MHRA Inspection, NMUH drew up an Action Plan to respond to the concerns that was approved by MHRA. EC had been unable to find an Action Plan. However, the Panel was satisfied that, although no copy of the document was before it in evidence, an Action Plan had been submitted to MHRA. SG had confirmed by email dated 26 September 2017 to the MHRA that responses had been received by MHRA from NMUH on 14 December 2007 and 24 January 2008, which following technical review were considered satisfactory.

59. The Blood Compliance Report submitted to the MHRA for 2011/2012 gave further details of the measures in place. These included the introduction of CCTV on the blood bank issue fridge. The MHRA wrote to NMUH by letter dated 23 August 2012 stating that its ‘operations are accepted as in general compliance with the .. legislation.’

60. Further, the evidence did not establish that NK had responsibility for ensuring that these systems were in place. KM accepted that she had this responsibility.      

61. Therefore, this sub-paragraph of the allegation has been found not proved.

‘b. You did not ensure that recall procedures were being adequately maintained and/or followed.’ 

62. Neither Dr AY nor KM had heard that there was an issue with blood recall and their evidence was to the effect that they would have expected to have heard if there was an issue with the procedures. That was also surprising in the case of KM, who was part of the HTT. KM’s evidence was that there were likely to be documents indicating that the procedures had been followed, which would have been on Dr R-H’s desk. However, as the Panel found, no enquiries on this matter were made of Dr R-H.

63. EC’s evidence on this aspect of the case was based on the Recall Audit. The identity of the author was not on the report or otherwise in evidence. The methods used to establish the conclusions in it were unclear and there was a total absence of underlying documents.

64. In view of the evidence of KM and Dr A-Y and the shortcomings in the Recall Audit referred to, this sub-paragraph of the allegation has been found not proved.    

‘4. Between July 2011 and December 2015 you did not ensure that staff were adequately trained and/or competent to work in the blood transfusion service.’

65. The evidence of both NK and GB was that AD did not carry out IT programming. He was not an IT Programmer and a deliberate decision was taken not to ask him to do such work. That responsibility fell on MA, who was the IT Manager as well as the Training Officer. He received an incremental salary point for his IT responsibilities, which he assumed when the relevant person moved to the Trust’s IT department. Therefore, this paragraph of the allegation has been found not proved.

Conclusions on the case against Mr Kafkarkou

66. In view of the Panel’s decision on the half-time submission and its findings with respect to paragraphs 1a, 1b and 4 of the allegation against NK, the factual case against him has failed in its entirety. Therefore, paragraphs 5 and 6 have not been established and accordingly, NK’s fitness to practise is not impaired.

Order

No information currently available

Notes

No notes available

Hearing History

History of Hearings for Mr Nicos A Kafkarkou

Date Panel Hearing type Outcomes / Status
20/05/2019 Conduct and Competence Committee Final Hearing Not well founded