Mr Stephen M King

: Biomedical scientist

: BS34692

: Final Hearing

Date and Time of hearing:10:00 21/08/2017 End: 17:00 25/08/2017

: Health and Care Professions Tribunal Service (HCPTS), 405 Kennington Road, London, SE11 4PT

: Conduct and Competence Committee
: Suspended

Allegation

During the course of your employment as Cytology Manager with East & North Herts NHS Trust between March 2013 and 30 April 2014 and with The Pathology Partnership from 1 May 2014 to the present date and while registered as a Biomedical Scientist, you:

 

1. On or around 23 December 2013, made an uncontrolled and/or unauthorised change to the staining agent from Harris' to Mayer's Haematoxylin, into the Gynaecological Cytology smear test screening process, and you:

 

a. did not follow the Change Control Process when making this change;

 

b. did not understand that the new staining agent, Mayer's Haematoxylin is not suitable for gynaecological Cytology and could have a detrimental effect on the staining of gynaecological Cytology material;

 

c. did not discuss this change with colleagues which meant the change went undetected until February 2014.

 

2. Did not respond appropriately to concerns raised in February 2014 by Colleague A at the reporting Laboratory, in that you:

 

a. between February 2014 and March 2014, sought to address the concerns of the reporting Laboratory by implementing adjustments to the strength of the screening agent and the timings but did not look to the agent itself;

 

b. reassured Colleague A at the reporting Laboratory that the issue had been addressed; c. in April 2014, requested withdrawal of affected slides from the independent quality assurance process, TEQA, on the basis that reporting was being transferred to a new

reporting Laboratory.

 

3. The matters set out in paragraphs 1 and/or 2 constitute misconduct and/or lack of competence.

 

4. By reason of your misconduct and/or lack of competence your fitness to practise is impaired.

Finding

Preliminary matters

1. The Registrant, Mr Stephen King, has neither attended this hearing nor been represented at it.

2. The Panel was satisfied that the letter dated 1 June 2017, addressed to the Registrant’s address as it was recorded on the HCPC Register informing him of this hearing, constituted good service of a notice of hearing.

3. After the Panel stated that it was satisfied that the Registrant had been sent a valid notice of hearing, the Presenting Officer applied for a direction that the hearing should proceed in the Registrant’s absence.

4. The Panel accepted the advice it received in relation to the application that the hearing should proceed in the Registrant’s absence, and in making its decision it considered the factors identified in the HCPTS Practice Note on the topic.  The conclusion of the Panel was that the hearing should proceed in the Registrant’s absence.  The reasons for this decision were as follows:

• On 31 July 2017 the Registrant returned a completed document entitled, “Response Proforma: Service of Papers”.  The Respondent replied “No” to the question whether he intended to appear in person at the hearing.  He gave the same response to the question whether he intended to be represented at the hearing.

• There has been no suggestion made by the Registrant that his decision not to attend the hearing was because of the particular hearing dates scheduled, and he has not applied for an adjournment of the hearing.

• It follows from the above that the Panel has concluded that the Registrant has voluntarily waived the right to attend the hearing.

• Furthermore, there are no grounds on which the Panel could conclude that he would be likely to attend a hearing on a future occasion were the present hearing to be adjourned.

• As the allegations concern events that occurred over three years ago and the three witnesses whom the HCPC intended to call to give oral evidence at the hearing were in attendance, the Panel concluded that the public interest in an expeditious resolution of the allegations outweighed the absence of the Registrant.

• These factors necessitated a direction that the hearing should proceed in the absence of the Registrant.

5. After the Panel directed that the hearing should proceed in the Registrant’s absence, the Presenting Officer applied to amend the factual particulars of the allegations.  The HCPC informed the Registrant by a letter dated 8 December 2016 that it intended to apply to amend the factual particulars of the allegations at the hearing.  The Registrant had raised no objection to the proposed amendments.  With regard to particular 3, the Panel considered that it would be more appropriate for the focus of the particular to be that the Registrant did not “review the staining process”, rather than a contention that he did not “alter the staining agent”.  In the judgement of the Panel the proposed amendments were appropriate, were consistent with the “case to answer” decision of the Investigating Committee and that the Registrant would not be prejudiced were they to be permitted.  Accordingly, the Panel acceded to the application to amend.  The allegation set out above is the allegation as amended.

Background

6. The Registrant commenced work as a Biomedical Scientist in the cytology department of the East and North Herts NHS Trust (“the Trust”) in 2009.  From March 2013, when a previous manager retired, he was in charge of the cervical cytology aspects of the work of the department, and he was in that role at the time of the events reflected in the factual particulars.

7. For some time there had been a plan to transfer the Trust’s cervical cytology work to another organisation known as “the Pathology Partnership”.  After a delay in that transfer being effected it eventually occurred on 1 May 2014 when the Registrant’s employment was transferred to the Pathology Partnership.

8. In the period leading up to the closure of the Trust’s cervical cytology service, the facility for abnormal cervical cytology reporting was reduced, and an arrangement was reached which resulted in slides that required such reporting to be screened by the Pathology Partnership. MH, a Consultant Biomedical Scientist in cervical cytology, raised concerns about the quality of the staining of the slides provided by the Trust, which affected the ability to identify correctly any abnormalities.  The HCPC’s case is that the Registrant assured MH that the issue with staining was being looked into and would be resolved.  It is alleged against the Registrant that this did not occur.  It is these events that underpin particular 2 of the allegations.

9. In April 2014 an independent Quality Assurance scheme for cervical cytology (“Technical EQA”) was convened.  Slides from the Trust were due to be provided for the purposes of the Technical EQA, but it is alleged that the Registrant withdrew the Trust’s slides that were due to be assessed.  Particular 3 is concerned with the alleged withdrawal of the slides from the Technical EQA process.

10. Subsequently, and after the Registrant’s employment had been transferred to the Pathology Partnership, a retrospective Quality Assurance process triggered an investigation into the issue of the staining of the Trust’s slides in the period January 2014 until the cessation of the Trust’s cervical cytology service at the end of April 2014.  It is the Registrant’s alleged actions with regard to the two staining agents that is the focus of particular 1.

Decision on Facts

11. The Panel has approached its decision making in relation to the factual particulars on the basis that it is for the HCPC to prove them against the Registrant on the balance of probabilities.

12. The HCPC called three witnesses to give evidence before the Panel, all of whom are Biomedical Scientists.  They were:

• RB, the Cytology Network Manager at the Pathology Partnership who line managed the Registrant after his employment was transferred to the Pathology Partnership.

• MH, the Consultant Biomedical Scientist at the Pathology Partnership who contacted the Registrant about slide quality in February 2014 and to whom reference was made earlier in this determination when the Panel explained the background to the case.

• EM, at the time relevant to the allegations, the General Manager for Diagnostic Services at the Trust.  EM line managed the Registrant until his employment was transferred to the Pathology Partnership in May 2014.

The Panel found each of these witnesses to be careful, measured and knowledgeable about the matters covered by their evidence.  The Panel was satisfied that their evidence could be safely relied upon.

13. In addition to the oral evidence of the three witnesses just identified, the HCPC introduced a bundle of documentary exhibits.

14. It has already been stated that the Registrant did not attend the hearing.  He did not provide any written submissions for the purposes of the present hearing.  In the Response Proforma document to which reference has already been made in connection with the Panel’s decision to proceed with the hearing in his absence, the Registrant stated that he had no memory of the events.

Particular 1(a) to (d) inclusive

15. As the entirety of particular 1 is concerned with the allegedly inappropriate change of staining agent, the Panel will set out its findings and will state what consequence those findings have for the specific sub-particulars.

16. The HCPC’s case is that in the period before the closure of the Trust’s cervical cytology service, the Registrant improperly permitted a change in the agent used to stain the cervical smear slides.  It is contended by the HCPC that Harris’ Haematoxylin (“Harris’”) was the appropriate staining agent, and that Mayer’s Haematoxylin (“Mayer’s”) was not appropriate for the slides in issue.  The evidence suggests that it was a depleted supply of Harris’ in the period leading to the closure of the Trust’s department that resulted in the Registrant using Mayer’s.  The Panel heard from the witnesses that, if there had been difficulty in ordering further supplies of Harris’, it would have been possible for the Registrant to borrow further supplies of it from another laboratory, as this was normal practice between laboratories.

17. The Panel is satisfied on the evidence presented to it that the Registrant, who was in charge of the department, made a change in the staining agent.  On 24 October 2014 EM wrote an email to the Registrant in which the following appeared, “…. there was an underlying problem in that …. we had changed the Haematoxylin from Mayers to Harris or vice versa …”, and the same day the Registrant replied to the email stating, “In answer to Haematoxylin half and half yes that is our normal practice.”  Furthermore, when he discussed the matter on 5 January 2015 in the context of a fact finding meeting for the purposes of an internal investigation, he confirmed that he was aware of the change in the staining agent.  In oral evidence before the Panel EM confirmed that she had seen the log recording the use of staining agents, and the Registrant’s initials appeared against the introduction of Mayer’s on 23 December 2013.

18. The Panel is also satisfied that a change control process was not followed.  Had it been it would have been documented, and interaction with the clinical lead on the issue would have been required.  No documentation or evidence of contact with the clinical lead has been discovered.  Furthermore, if such a process had been followed, tests to ensure correct timings would have been undertaken, and the fact that poor staining resulted leads the Panel to conclude that testing was not undertaken.  Particular 1(a) is proven.

19. The Panel accepts the evidence that Mayer’s was not an appropriate staining agent.  In the experience of witnesses who gave evidence before the Panel, it is an agent that is not used for cervical cytology slides.  The primary reason for it being unsuitable is that it does not appropriately stain the cell nucleus.  Again, the fact that after its introduction by the Registrant poor slide quality resulted is further evidence of its unsuitability.  Particular 1(b) is proven.

20. The Panel is satisfied that memos and communications were checked to establish whether the Registrant had informed colleagues of the change in staining agent he was introducing.  As part of the change control procedure it would have been necessary for the matter to have been discussed at both the proposal stage and the introduction stage, and there would have been a need to undertake training of people working alongside the Registrant.  However, no records were discovered.  Furthermore, despite the fact that MH raised the issue of poor staining with the Registrant, the latter did not disclose to MH the change he had introduced.  For these reasons the Panel is satisfied that the Registrant did not discuss the change with colleagues.  Particular 1(c) is proven.

21. As to the Registrant’s actions resulting in there being a mix of Harris’ and Mayer’s, the Registrant’s acknowledgment that this occurred in his email to EM dated 24 October 2014 has already been referred to.  The Panel rejects the Registrant’s assertion in this email that mixing agents in this manner could be considered to be “normal practice” as he contended.  This was contradicted by the evidence given by the witnesses called by the HCPC.  The Panel finds that even if it had been appropriate to change the staining agent to Mayer’s (which it would not have been for the reasons already expressed) the entirety of the stain should have been changed.  Particular 1(d) is proven.

22. The consequence of these findings is that the entirety of particular 1 is proven.

Particular 2

23. On 19 February 2014, MH wrote an email to the Registrant which was entitled “staining”.  The body of the email read, “Sorry but the staining still v poor especially the nuclei. In my opinion would fail Tech EQA.”  MH again wrote to the Registrant by email on 6 March 2017.  The tone of the Registrant’s responses to MH was that the issue was being addressed, a fact demonstrated by the Registrant’s email dated 6 March 2014 in which he stated, “still working through the backlog but the staining at the present is fine.”  That the Registrant did not appropriately address the concerns that were raised about the quality of staining is consistent with MH’s evidence to the Panel that the quality of the slides did not significantly improve and he gave up raising the matter directly with the Registrant.

24. The Panel is satisfied that particular 2 is proven.

Particular 3

25. At the fact finding meeting on 5 January 2015 to which previous reference has been made, the Registrant accepted that he had withdrawn slides that had been submitted for the purposes of the TEQA independent quality assurance process.  The explanation he gave at that meeting for the withdrawal was that at that time no staining was taking place, but the Panel finds that this was not an acceptable reason for them being withdrawn.

26. Particular 3 is proven.

Decision on Grounds

27. In deciding on the grounds, the task of the Panel is to decide if the facts proved amount to misconduct and/or demonstrate a lack of competence on the part of the Registrant.

28. The Registrant was an experienced Biomedical Scientist working at a senior level in an area of Biomedical Science with which he was very familiar.  None of the shortcomings identified by the Panel’s findings represented a failure to perform a task that would or should have been unusual or difficult.  The Panel is satisfied that this is not a case of lack of competence.

29. Not acting in a way that jeopardises safe and effective practice, and following accepted procedures that are designed to achieve reliability in reporting, are requirements that lie at the heart of the professional obligations of a Biomedical Scientist.  That the Registrant breached these requirements is demonstrated by the fact that he practised in a manner that did not accord with a number of the Standards of Proficiency for Biomedical Scientists in force at the relevant time   He also breached a number of the Standards of Conduct, Performance and Ethics, namely, Standard 1 (“You must act in the best interests of service users”), Standard 7 (“You must communicate properly and effectively with service users and other practitioners”) and 13 (“You must …. make sure that your behaviour does not damage the public’s confidence in you or your profession”).

30. The findings of the Panel are of the utmost seriousness.  The consequence of the Registrant’s actions was that it was necessary to review in excess of 10,000 slides that had been screened, and in excess of 600 women who had undergone smear tests had to be contacted for further smear tests to be carried out.  In the event, despite efforts being made by the GPs of the patients concerned, not all women it was intended to recall attended for further tests.  To be clear, the HCPC’s case is not advanced on the basis that as a result of poor slide quality malignancy was missed in any particular case, but equally the Panel is satisfied that the Registrant’s actions gave rise to such a risk.  The Panel has no doubt that the recall exercise would have caused the women concerned considerable anxiety and distress and, unsurprisingly, it gave rise to patient complaints.

31. The Panel is satisfied that the Registrant’s actions taken in the round are properly to be categorised as misconduct.  The Panel takes the view that fellow professionals would consider what he did to be deplorable.

Decision on Impairment

32. It is clear that the Registrant’s fitness to practise was impaired in the period January to April 2014.  The issue for the Panel, however, is whether the established misconduct is currently impairing his fitness to practise.  In reaching a decision on this issue it is necessary for the Panel to consider both the personal component and public component relevant to that issue.

33. As has already been stated, the Registrant’s employment with the Trust was transferred to the Pathology Partnership in May 2014.  The evidence before the Panel was that after working at the Pathology Partnership for some time he had a long period of sick leave, and in a letter dated to the 31 July 2017, the Registrant stated that he had resigned from his employment and had offered to be removed from the HCPC Register.  The extremely limited engagement in this fitness to practise process does not enable the Panel to conclude that he has developed any meaningful insight into his shortcomings and the consequences of them for patients and other professionals.  Furthermore, the Panel has received no evidence of any remedial actions taken by him to date or any intention to take such actions in the future.  In these circumstances the Panel has concluded that there would be a significant risk of recurrence of comparable behaviour were the Registrant to be permitted to return to practise.  This finding means that upon consideration of the personal component, a finding of current impairment of fitness to practise is required.

34. The Panel is also satisfied that a finding of current impairment of fitness to practise is required in the wider public interest.  It is necessary to protect the public, to declare and to uphold proper professional standards.  Given the seriousness of the failings and the consequences, both actual and potential, the Panel is satisfied that a fair minded and fully informed member of the public would be dismayed were the Registrant’s actions not to be marked by a finding of impairment of fitness to practise.

35. The consequence of the findings that the Registrant’s fitness to practise is impaired by reason of misconduct is that the Panel must go on to consider the issue of sanction.

Decision on Sanction

36. After announcing the decision that the misconduct allegation is well founded, the Panel received the Presenting Officer’s submissions on sanction.

37. The Presenting Officer referred to the serious features of the case that were identified by the Panel in its findings on the allegation.  She also referred to passages of the HCPC’s Indicative Sanctions Policy when taking the Panel through the available sanctions.

38. The Panel has approached the decision on sanction by reminding itself that a sanction is not to be imposed to punish a Registrant against whom findings have been made.  Rather, a sanction is only to be imposed to the extent that it is required to protect the public and to maintain a proper degree of confidence in the registered profession and in the proper regulation of that profession.  To ensure that these principles are applied it is necessary for the Panel to first consider whether any sanction is required at all.  If a sanction is required, then the available sanctions must be considered in an ascending order of seriousness until one is reached that sufficiently addresses the proper sanction aims.  As the Panel has made a finding of misconduct the entire sanction range up to, and including, striking off is available.

39. The Panel does not intend to repeat all that has already been said about the seriousness of the Registrant’s misconduct.  This misconduct was very serious, particularly with regard to the actual and potential consequences for the women concerned.  The Panel has not overlooked the fact that the Registrant’s department was in the process of running down in preparation for the transfer to the Pathology Partnership, and, although the Panel does not find that this factor excuses his behaviour, it is fair to acknowledge that there would have been extra stresses imposed on the Registrant at the relevant time.  These were exacerbated, as it appears from LR’s record of the fact finding meeting on 5 January 2015, in that the Registrant felt, “under pressure to take on the interim cytology lab manager role … (as) he had perceived there to be no other option available at the time”.   A finding already made, namely that there is a risk of repetition, is one that lies at the heart of the Panel’s decision on sanction.  The risk of repetition will continue unless and until the Registrant acknowledges his failings in December 2013 and the early months of 2014 and takes steps to justify a finding that the risk has been removed.  Were the Registrant to repeat behaviour of the sort found against him there would clearly be a significant risk of harm to patients.

40. In the judgement of the Panel the findings made, and the risks presented by the Registrant, require the imposition of a sanction.  A Caution Order would neither reflect the seriousness of the case nor afford adequate protection from the risk of harm.

41. The Panel is also satisfied that a Conditions of Practice Order is not appropriate.  The Registrant is not working as a Biomedical Scientist, and even if he were so working, it would be difficult to compose conditions relevant to the nature of the misconduct which relates to an error made by the Registrant which he failed to recognise or appropriately address.

42. The Panel next considered the options of the making of a Suspension Order and a Striking Off Order.  In the judgement of the Panel, unless and until the Registrant comes to a full understanding of the error he made in introducing the wrong staining agent without proper change control in December 2013, and the consequences of this for the quality of the staining subsequently undertaken in his laboratory prior to its closure, it is necessary that an order is made that prevents him from practising as a Biomedical Scientist.  The Panel notes that the Registrant has stated that his current intention is that he no longer wishes to work as a Biomedical Scientist or continue his registration with the HCPC.  The Panel further notes that the Registrant has been off work due to health reasons since the end of August 2015.  If it could be satisfied that the views expressed by the Registrant represented his settled intention, and therefore that his misconduct could not be remedied, then the only appropriate sanction would be the making of a Striking Off Order.

43. The Panel has stepped back from making a Striking Off Order today.  The reason for it doing so is to allow the Registrant to reflect on the Panel’s decision and to give him the opportunity to decide if he wishes to take steps to return to his profession.  This is because the Registrant’s misconduct is capable of being remedied.  It requires an acceptance on his part of the error he made in substituting the wrong staining agent and of his subsequent failure to address the consequences of the substitution.  The Panel has decided that the appropriate sanction at the present time is a Suspension Order, and it makes this order for a period of 12 months.

44. The Registrant should be aware that in common with all Suspension Orders, the order made today will be reviewed before it expires.  When the Suspension Order is reviewed the reviewing panel will decide whether a further sanction is required, and, if it is, what that sanction should be.  The Panel does not intend to bind the reviewing panel in any way but it is important that the Registrant understands the powers that will be available when the review is undertaken.  The reviewing panel will have all the sanction powers that are available to the present Panel, and that will include the making of a Striking Off Order.  Without positive engagement by the Registrant and significant evidence that he has taken, or at least is in the process of taking, steps to remedy the shortcomings identified, he can realistically expect a Striking Off Order to be made on the review.  In the circumstances of this case, the present Panel considers it best to leave it to the Registrant, should he wish to continue to practise, to decide how he might satisfy the reviewing panel that the risk he currently presents has been reduced.

Order

That the Registrar is directed to suspend the registration of Mr Stephen M King for a period of 12 months from the date this order comes into effect.

Notes

The order imposed today will apply from 19 September 2017 (the operative date).

This order will be reviewed again before its expiry on 19 September 2018.

Hearing history

History of Hearings for Mr Stephen M King

Date Panel Hearing type Outcomes / Status
21/08/2017 Conduct and Competence Committee Final Hearing Suspended