Mr Shanthiratne Semage

Profession: Biomedical scientist

Registration Number: BS59257

Hearing Type: Final Hearing

Date and Time of hearing: 10:00 10/05/2021 End: 17:00 10/05/2021

Location: Virtual via Video Conference

Panel: Conduct and Competence Committee
Outcome: Conditions of Practice

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Allegation

Whilst registered with the Health and Care Professions Council as a Biomedical Scientist and employed by Cambridge University Hospitals NHS Foundation Trust, you:

1a) Between March 2017 and October 2018 did not meet national guidelines for high grade and low grade sensitivity slides consistently;

1b) Between September 2017 and October 2018 did not review the required number of cervical cytology samples in accordance with national guidelines.

2. The matters described in paragraph 1a) and/or 1b) constitute lack of competence.

3. By reason of your lack of competence your fitness to practise is impaired.

Finding

Preliminary Matters:

Application to amend

1. At the outset of the hearing, Ms Reid, appearing on behalf of the HCPC, applied to amend the particulars of the allegation. She explained that on 7 April 2020, the Registrant had been sent a letter outlining the proposed amendments, and had not raised any objection to them. She submitted that the proposed amendments better reflected the evidence. Ms Reid submitted that the proposed amendments would not result in either under-prosecution or prejudice to the Registrant.

2. Ms Reid invited the Panel to strike through the stem of original particular 1, and to strike through original particular 1(a), as it was, in effect, duplicitous to original particular 1(b). She invited the Panel to amend original particular 1(b) by adding the timeframe between March 2017 and October 2018, and to re-number it particular 1(a).

3. In relation to original particular 1(c), Ms Reid offered no evidence. She confirmed that this would reflect the anticipated evidence of IM, whose witness statement stated that the Registrant’s HPV Pathway Competency test results indicated that he passed the ‘HPV testing competency’ on 17th June 2018 and there were no concerns in relation to the Registrant’s test results. As such, Ms Reid conceded that there was no evidence to support original particular 1(c).

4. Ms Reid submitted that the addition of a new particular 1(b) would more accurately reflect the concerns in relation to the number of samples being reviewed by the Registrant. She submitted that this was part of the same general concern about competency, rather than being an entirely new allegation against the Registrant. Ms Reid submitted that the inclusion of proposed new particular 1(b) did not increase the overall seriousness of the case.

5. The Registrant did not raise any objection to the proposed amendments.

6. Having accepted the advice of the Legal Assessor, the Panel was satisfied that the amendments sought did not materially change the nature of the allegations. It considered that the Registrant had been put on notice in April 2020 that the HCPC would make the application to amend the allegation in the terms set out, and had not raised any objection either in writing or at the hearing today. The Panel was of the view that the proposed amendments appeared to better reflect the anticipated evidence. It also considered that they fairly separated the allegations of not meeting national guidelines in relation to both quality and quantity of reviewing cervical cytology slides. Consequently, the Panel allowed the HCPC application to both amend the allegation in the terms identified (and as annotated above), and to offer no evidence on original particular 1(c).

Application for parts of the hearing to proceed in private

7. During the course of the case, it was evident to the Panel that there would be references to the Registrant’s health. Consequently, having heard and accepted the advice of the Legal Assessor, the Panel was satisfied that it was justified to hear in private those matters which related to the Registrant’s health, in order to protect his private life.

Background:

8. The Registrant is a Biomedical Scientist registered with the HCPC. He was employed by Cambridge University Hospital NHS Foundation Trust (‘the Trust’) from 22 February 2005 until 23 November 2018.

9. The Registrant was initially employed by the Trust as a Trainee Biomedical Scientist. On 22 April 2008 he was promoted to the role of a Band 6 Advanced Biomedical Scientist within the Cervical Cytology Department. In this role, one of the Registrant’s responsibilities was to review and assess cervical cytology samples received by the Trust as part of the National Health Service Cervical Screening Programme.

10. According to the National Guidelines for performance in Cervical Cytology, issued under the NHS Cervical Screening Programme (the National Guidelines), once a practitioner is qualified to undertake primary screening of cervical cytology samples, the accuracy of their assessments is monitored.

11. The National Guidelines set out that a practitioner should review a minimum of 3,000 slides per year. They state that primary screeners should, as a minimum, accurately detect 95% of samples that display high-grade abnormalities and 90% of all or low grade abnormalities. If a practitioner does not meet these criteria, they are considered to be ‘out of range.’

12. As part of the Quality Control system to monitor the accuracy of a primary screener’s assessments, all samples assessed are checked by a second Biomedical Scientist undertaking a rapid review. However, if a practitioner was deemed to be ‘out of range’, the Trust would then implement a ‘double screening’ process of the samples, meaning that a second Biomedical Scientist would assess the slide again from the perspective of a primary screener.

13. The Registrant’s line manager was IM, who was, at the relevant time, the Chief Biomedical Scientist at the Trust. He was the Registrant’s line manager from September 2011 until November 2018, save for a two-year period from 2012 to 2014 when IM was on secondment. In his role as the Registrant’s line manager, IM was responsible for conducting formal and informal one-to-one meetings with the Registrant.

14. In or around May 2017, as a result of the monitoring process to detect a practitioner’s accuracy levels, the Registrant was identified as being ‘out of range’ and concerns were raised in relation to his competence. Those concerns related to the accuracy of the cervical cytology primary screening conducted by the Registrant between March 2017 and October 2018. It is alleged that, between these dates, the Registrant did not consistently meet the National Guidelines for accuracy in relation to high grade and low (all) grade sensitivity slides. It is further alleged that between September 2017 and October 2018, the Registrant did not review the required number of cervical cytology samples in accordance with national guidelines.

15. On 31st May 2017, the Registrant was advised that the informal stage of performance management would begin. As part of the informal stage, a Performance Improvement Plan (PIP) was drawn up. Objectives and support were set out in the PIP and included the stipulation that the Registrant’s review of slides was to be ‘double screened’. The PIP also set out an increased frequency of 1-1 meetings with the Registrant’s line manager.

16. The Trust was not satisfied that the Registrant achieved a sustained improvement, whilst on the informal stage of performance management and so on 14 November 2017, the Registrant was moved to stage 1 of the Trust’s formal Managing Performance Process. On 11 July 2018, the Registrant was moved to stage 2 of the Trust’s formal process. The Trust did not consider that the Registrant had successfully managed to address the concerns during the informal and formal periods of the performance management process. Consequently, the matter was referred to the HCPC on 7th December 2018.

Decision on Facts:

17. On behalf of the HCPC the Panel heard evidence from IM. The Panel also received documentary evidence, including:

1) A copy of the Registrant’s job description;

2) A copy of the Registrant’s Performance Improvement Plan (PIP);

3) Copies of correspondence in respect of the Trust’s Managing Employee Performance Process;

4) Copies of correspondence from Occupational Health;

5) Copies of charts compiled by IM recording the rolling annual number of slides primary screened between February 2017 and October 2018, and the grade sensitivities between February 2017 and October 2018; and

6) Copies of the relevant policies and procedures, including the national guidelines for performance in Cervical Cytology; the Trust Guidance on Managing Employee Performance; and the NHS Cervical Screening Programme.

18. The Registrant gave evidence. At the outset of the hearing, following the amendment of the particulars, he admitted particular 1(a). During the course of his evidence, he accepted particular 1(b).

19. The Panel heard and accepted the advice of the Legal Assessor. It understood that the burden of proving each alleged fact rests on the HCPC. It further understood that the HCPC will only be able to prove an alleged fact if it satisfies the required standard of proof, namely the civil standard, whereby it is more likely than not that the alleged incident occurred.

20. At the outset of its deliberations, the Panel conducted an assessment of the witnesses who had given evidence, namely IM called by the HCPC, and the Registrant who gave evidence on his own behalf.

21. The Panel considered that IM was a broadly credible and professional witness, who was knowledgeable about the processes within the Department, including the performance management process. The Panel considered that he was consistent and balanced in his evidence, and had been supportive and fair towards the Registrant. In relation to the figures and graphs which IM had produced, the Panel was mindful that it did not have the source material underpinning that information, but IM had explained his process in creating the figures and graphs, namely that he had pulled the data from the computerised electronic data recording systems, ‘LIMS’ and ‘Cyres’ and used that to create the figures and graphs.

22. The Panel considered that the Registrant had been straightforward, honest and open in his evidence. Having heard him give evidence, it appeared to the Panel that the Registrant’s natural manner was to try to please colleagues, which may have inhibited him from effectively managing his own practice and fully informing management of the departmental pressures he was under in respect of his other responsibilities. The Panel considered that the Registrant had made some good points in his evidence, for example demonstrating that the Cyres recording system did not retrospectively take into account later histology results which supported the original screener’s findings and so was not a ‘fool proof’ system in recording accuracy.

Particular 1(a):

Between March 2017 and October 2018 did not meet national guidelines for high grade and low grade sensitivity slides consistently.

23. The Panel finds particular 1(a) proved.

24. The Panel understood the national guidelines to be those issued to laboratories providing testing under the NHS Cervical Screening Programme. They are set out as References: Guidelines for performance in cervical cytology, and IM confirmed that this guidance was in place throughout the Registrant’s employment.

25. In particular, the national guidelines entitled Achievable Standards, Benchmarks for reporting and Criteria for evaluation cervical cytopathology, NHSCSP Doc 2 2ed 2000, table states:

For all abnormalities – 90% or more;
For high grade abnormalities – 95% or more.
Performance indicator ranges for sensitivity of primary screening based on rapid review

26. The updated national guidelines, entitled Public health functions to be exercised by NHS England: Service specification No.25 Cervical Screening, 2013, maintained the same sensitivities. For cytology it stated:

1) Laboratory sensitivity for all abnormalities (>90%)
2) Laboratory sensitivity for high grade abnormalities (>95%)

27. IM told the Panel that at the Trust, a qualified practitioner would undertake the primary screening of a sample/slide (under a microscope) and assess whether it was abnormal, potentially abnormal, negative or inadequate.

28. An abnormal or potentially abnormal sample is when the primary screener detects abnormal or potentially abnormal cells in the sample. In such a case, the sample is sent either to a checker or directly to a consultant to report. A negative sample is where the primary screener does not detect any cell normalities. In such a case the sample is then assessed by a second qualified practitioner as a rapid review, which is a method of quality control rather than a second, full primary screening of the sample. An inadequate sample is where, for example, there is insufficient material for the sample to be representative of the cervix. In such a case the sample is assessed by a second qualified practitioner by a rapid review.

29. IM told the Panel that each practitioner would enter the results of the samples they had reviewed onto the electronic laboratory information system (LIMS). The laboratory manager would then extract data from LIMS and import it into a computer programme called ‘Cyres’. The Cyres system would be used to generate statistics regarding laboratory and individual practitioner performance. IM told the Panel that he was not familiar with the exact mechanism by which Cyres generated statistics, however he said that the process was to ensure that both the laboratory and individual practitioners met the national guidelines in terms of both workload and performance.

30. IM told the Panel that each month the laboratory manager would download data from the electronic laboratory system and use the data to calculate the percentage of abnormalities detected by each individual practitioner. He said this would be used to ascertain whether the practitioner was ‘within range’, meaning that they had picked up, at a minimum, 95% of samples displaying high-grade abnormalities and 90% of all grade (low grade) abnormalities in accordance with the guidance.

31. The Panel was provided with a table recording monthly percentages for high-grade and all-grade sensitivities for the period from February 2017 to October 2018. It was also provided with two accompanying graphs plotting the percentages of both the high-grade and all-grade sensitivities for that period as set out in the table. IM explained that he had created the table and graphs about the Registrant. He said that he had pulled the data from the Cyres programme and recorded it in an Excel table and had also plotted the data onto the graphs. He said that the percentage recorded for each month represented a 12 month rolling annual figure.

32. The Panel was mindful that it did not have the source material from Cyres which underpinned the table and graphs, and so it was not possible for it to independently test whether IM had accurately recorded the data pulled from Cyres. However, the Panel had found IM to be a credible, professional and balanced witness and considered that it was more likely than not that he had accurately recorded the information. Further, it noted that the Registrant had not disputed that the figures in the table accurately represented the data pulled from Cyres, rather, he had raised the issue that the Cyres system did not retrospectively correct percentages by taking into account later histology results which supported the original screener’s findings.

33. IM also said that in around January and February 2018, the Registrant had been given a validation set of four hundred slides to review as a training exercise, which were not recorded on Cyres and so did not appear within the table. The results of this validation set of slides was therefore not represented on the graphs. However, IM said that the results also ought to be taken into account, because they represented a significant workload.

34. The Panel also considered the significance of the two sensitivity tables produced for between 1 October 2016 – 30 September 2017, and 1 August 2017 – 30 September 2017. The Registrant’s evidence was that these supported his contention that there were occasions when the second screener disagreed with the Registrant’s assessment of the slide but either the laboratory or histology results later confirmed his initial assessment as accurate. The Registrant’s position was that the Cyres programme was not subsequently updated to reflect this.

35. The Panel accepted that the sensitivity tables did indicate three or four occasions where the Registrant’s assessment was subsequently confirmed by the laboratory of histology results. However, the Panel noted that the tables represented a very small snapshot of slides reviewed, and were appended to the Registrant’s personal development plan to be discussed in a supervision session with IM. The Panel did not consider that they undermined the percentages of sensitivity produced by the Cyres programme.

36. The Panel also noted that whilst the Registrant had fallen below the national guidelines required rate of 95% for high grade abnormalities from March 2017, it was less than 1% below between March and August 2017. However, the Panel considered that the Registrant had fallen considerably below the national guidelines between March and September 2018, with his accuracy rate of detection falling between 8 – 9% below the national guidelines required rate of at least 95%.

37. In all the circumstances, the Panel was satisfied from all the evidence that it was more likely than not that the Registrant did not meet the national guidelines for high grade and low grade sensitivity slides consistently between March 2017 and October 2018, and therefore particular 1(a) is proved.

Particular 1(b):

Between September 2017 and October 2018 did not review the required number of cervical cytology samples in accordance with national guidelines.

38. The Panel finds particular 1(b) proved.

39. The Panel understood the national guidelines to be those issued to laboratories providing testing under the NHS Cervical Screening Programme (NHSCSP). The Panel had a copy of the document entitled: Laboratory Organisation: A Guide for Laboratories Participating in the NHS Cervical Screening Programme, NHSCSP Doc 14, 2003. The Panel had regard to section 2 of the Guide where it stated that the recommendations for rates of working were as follows:

1) Five slides screened per attendance hour for the NHSCSP;
2) Eight slides per hour primary screening rate;
3) Minimum number of slides per annum: a reasonable target for skill maintenance would be 3000 slides per annum. The number of screening programme slides processed/reviewed annually by each individual screener, whether part time or not, must be greater than 3000 slides.

40. The Panel noted that the national guidelines for the expected minimum annual levels of slides to be reviewed applied to both full time and part time employees, which it considered to be important, as the Registrant was a full time employee. These required rates were also set out within the Registrant’s job description.

41. The Panel took account of the figures presented by IM in his table taken from the Cyres programme. From September 2017, they demonstrated that the Registrant’s rolling annual total of slides reviewed consistently dropped below the minimum requisite numbers set out in the national guidelines. The Panel noted that, initially, the figures dipped just below 3,000 slides, but by February 2018 the numbers had plummeted to around 1,500 slides short of the requisite numbers.

42. The Panel had regard to the evidence of IM, who stated that at a formal review meeting with the Registrant, which took place on 9 May 2018, it was discussed that the Registrant was not screening the required number of slides. IM said that the Cyres figures for April 2018 showed that the annual rolling rate of slides reviewed by the Registrant was 1,278 slides out the minimum 3,000 slides he was required to review within a rolling year.

43. The Panel considered the issues which may have impacted upon the Registrant’s ability to review the requisite number of slides.

44. The Panel bore in mind that IM had explained that the training exercise of analysing the 400 validation slides would have represented a significant amount of time and effort and ought to be added to the Registrant’s annual rolling totals from around January 2018. The Panel was satisfied, however, that even when adding in the additional validation slides, the Registrant’s annual rolling totals would nevertheless have fallen significantly short of the minimum target of 3,000 slides. From February 2018 to September 2018, the Panel was satisfied that the Registrant’s rolling annual totals would still have been around 1,000 slides short of the minimum target even if the 400 validation slides were added to his annual rolling figures for slides reviewed.

45. However, the Panel also took account of the evidence of IM that the Registrant had been advised to take longer to review each slide. IM told the Panel that to achieve the minimum target of 3,000 slides per year the Registrant would need to review around 12 slides per day, which would take around two to three hours to complete. The Panel considered that the minimum annual target of 3,000 slides set out in the national guidelines would still be reasonably achievable for him. In reaching this conclusion, the Panel bore in mind that the national guidelines contemplated that the minimum annual target would be achievable for part time as well as full time employees.

46. The Panel also had regard to the Registrant’s evidence in which he explained that he had been given a great deal of additional responsibilities. In particular, he had to undertake an extensive amount of work coming in from other laboratories, the inference being that it was difficult for him to also review the required number of slides. The Panel accepted the Registrant’s evidence that the laboratory was very busy and there were additional pressures and responsibilities on him, in particular in relation to work coming in from other laboratories.

47. However, the Panel again bore in mind the evidence from IM, that it would take around two to three hours a day to achieve the minimum annual target. The Panel also considered that the Registrant was aware of the national guidelines’ minimum annual target as they were replicated in his job description. Accordingly, the Panel was satisfied that attaining the minimum target should have been a high priority for the Registrant, and he had a responsibility to achieve those standards of proficiency as registered Biomedical Scientist.

48. Even having regard to the issues which may have impacted upon the Registrant in meeting the minimum annual target set out in the national guidelines, the Panel was satisfied that they were not individually or collectively sufficient to mean that the Registrant could not reasonably have achieved the target. Accordingly, the Panel was satisfied that the Registrant did not review the required number of cervical cytology samples in accordance with national guidelines and particular 1(b) is therefore proved.

Decision on Grounds:

49. The Panel next considered whether the matters found proved, amounted to a lack of competence on the Registrant’s part, and if so, whether by reason thereof, his fitness to practise is currently impaired.

50. The Panel considered the submissions made by Ms Reid on behalf of the HCPC. She submitted that the Registrant’s failure to meet the national standards for both screening sensitivity and number of slides reviewed was persistent, prolonged, and showed no real improvement over time in spite of ample support and training opportunities provided to the Registrant by the Trust.

51. Ms Reid conceded that when the Registrant first fell out of range, in February 2017 it was only slightly below his targets. However, she submitted that the problem grew worse over time and both his sensitivity rates and the number of slides reviewed eventually fell well below the national guidelines and remained at those low levels until the Registrant left the Trust in November 2018. Ms Reid submitted that the national guidelines represent minimum mandatory levels of competence, and any prolonged period of falling below these requirements represented a clear failure to meet minimum professional standards.

52. Ms Reid submitted that the Registrant had breached the following standards of the

Standards of Proficiency for Biomedical Scientists (the Standards):
• Standard 1.2 – recognise the need to manage their own workload and resources effectively and be able to practise accordingly.
• Standard 3 – be able to maintain fitness to practise.
• Standard 3.3 – understand both the need to keep skills and knowledge up to date and the importance of career-long learning.

53. The Panel heard and accepted the advice of the legal assessor. In her advice she cited the cases of: Calhaem [2007] EWHC 2606 (Admin) and Holton v GMC [2006] EWHC 2960. The Panel was aware that any finding of a lack of competence was a matter for the independent judgement of the Panel.

54. The Panel considered that cytology screening is a narrow field of a Biomedical Scientist’s work. Nevertheless, it took into account that the standards for a Biomedical Scientist appointed into that field are set by the national guidelines. The Panel considered that there were three elements to the question of whether or not the facts found proved amount to a lack of competence, namely:

1) Did the Panel have a fair sample of the Registrant’s work by which to assess his level of competence?

2) What would be the standards expected of a reasonably competent Biomedical Scientist?

3) Were the standards attained by the Registrant unacceptably low when measured against the standards of a reasonably competent Biomedical Scientist?

Question 1

55. In relation to whether the evidence represented a fair sample of the Registrant’s work, the Panel considered the timeframe over which the alleged lack of competence occurred. The Panel acknowledged that the Registrant had not been permitted to review slides in October 2018, and so did not included this period in its assessment. Nevertheless, in terms of the annual requirement to review a minimum of 3,000 slides per year, the Panel considered that the Registrant had consistently fallen significantly below the required rate for period from October 2017 to September 2018, a period of around 11 months.

56. In terms of the sensitivity rate of detecting high grade and all grade abnormalities, the Panel considered that the Registrant had consistently fallen significantly below the required percentages for the period from February 2018 to September 2018, a period of around eight months. The Panel considered that in respect of both time and quantity, the evidence represented a fair sample of the Registrant’s work.

Question 2

57. The Panel bore in mind IM’s evidence that in practical terms, reviewing 3,000 slides in a year represented around two to three hours of work during the working day. Whilst the Panel accepted that there were other work responsibilities on the Registrant, it nevertheless considered that this was an achievable target for the Registrant, who had previously comfortably exceeded the minimum number of slides to review, including between February 2017 and August 2017. The Panel was, therefore satisfied that the national guidelines requiring an annual rate of reviewing 3,000 slides represented the standard to be expected of a reasonably competent Biomedical Scientist.

58. The Panel acknowledged that there was an element of subjectivity involved in reviewing a slide and assessing whether an abnormality was present. Nevertheless, it considered that this was taken into account by the national guidelines when setting the sensitivity levels for high and all grade abnormalities. Given the potential for harm for a patient, particularly if a high grade abnormality was not detected, the Panel was satisfied that achieving the percentages as set out in the national guidelines represented the standard to be expected of a reasonably competent Biomedical Scientist.

Question 3

59. The Panel had regard to the number of slides being reviewed by the Registrant when compared to the requirements set under the national guidelines. In October 2017, the Registrant’s annual rolling number of slides reviewed missed the requirement by over 400 slides. Between March 2018 and September 2018, the Registrant’s annual rolling number of slides reviewed missed the requirement by over 1,500 slides. In the Panel’s judgement, this rate was unacceptably low when compared against the standards expected of a reasonably competent Biomedical Scientist.

60. The Panel had regard to the percentages of high grade and all grade abnormalities successfully detected by the Registrant. Between February and August 2017, the Registrant missed the 95% detection of high grade abnormalities by less that 1%, which the Panel accepted may represent a small number of the total slides reviewed. However, between March and September 2018, the Registrant consistently missed the 95% detection of high grade abnormalities by around 8% – 9%. In the Panel’s judgement, this rate was unacceptably low when compared against the standards expected of a reasonably competent Biomedical Scientist.

61. The Panel was of the view that the Registrant had been provided with extensive support from IM in the form of regular supervision sessions. It acknowledged that the Registrant was working in a challenging and busy department and there were many additional demands on his time. However, for a significant period of time the Panel identified that the Registrant was not able to review the slides to the appropriate and safe standard to be expected of a reasonably competent Biomedical Scientist. In the Panel’s judgement, the evidence demonstrated that the Registrant did not have the ability to manage his own workload and resources effectively or manage his fitness to practise accordingly. Consequently, the Panel was of the view that the Registrant had breached standards 1.3, 3 and 3.3 of the Standards.

62. In all the circumstances, the Panel concluded that the Registrant had persistently fallen below the standards expected of a reasonably competent Biomedical Scientist, over a considerable period of time, and as judged against a fair sample of his work. As such, in the Panel’s judgement, the facts found proved amount to a lack of competence on the Registrant’s part. The Panel concluded that the Registrant’s lack of competence is sufficiently serious to lead the Panel to a consideration of whether or not his fitness to practise is currently impaired by reason of that lack of competence.

Decision on Impairment:

63. Having determined that the Registrant's actions amounted to lack of competence in respect of the charges found proved, the Panel went on to consider whether his fitness to practise was currently impaired as a consequence of that lack of competence.

64. The Panel heard and accepted the advice of the Legal Assessor. It had regard to the HCPC's Practice Note on impairment, and in particular the two aspects of impairment, namely the ‘personal component’ and the ‘public component’, based on the case of Cohen v GMC [2008] EWHC 581 (Admin). The Panel was aware that consideration of impairment only arises in the event that the Panel judges that the facts found proved do amount to a lack of competence and that in determining current impairment, the consideration is to look forward from today.

65. In relation to insight, the Panel was of the view that the Registrant had some insight in that he recognised that he was not consistently achieving the required standards. However, the Panel considered that he did not understand the potential risk to patients and increased workload on colleagues, as he maintained that there was no actual risk of harm because the samples which he reviewed were double checked by another Biomedical Scientist who would pick up any oversight by the Registrant. The Panel concluded that the Registrant’s insight into the risks of his failings was not sufficiently developed.

66. In relation to remediation, the Panel firstly considered whether the Registrant’s lack of competence was capable of remediation. It was satisfied that there was no character flaw which may impede remediation. The position was that his skill level had fallen significantly below the required standards in the area of cytology, but the Panel was of the view that through training, refresher courses and regaining experience in the laboratory, the Registrant’s lack of competence was capable of remediation.

67. The Panel next considered whether the Registrant had taken remedial action to address his lack of competence. He told the Panel that he had been reading monthly professional journals, including SCAN and IBMS. However, the Panel bore in mind that the Registrant had not worked in cytology since he had left the Trust in October 2018. It also noted that when the Registrant had undertaken the exercise of reviewing 400 training slides he had achieved the required standards, but had not been able to replicate this when reviewing actual slides. The Panel was not satisfied that in the absence of practical experience, for example shadowing a Biomedical Scientist in the laboratory, the academic reading which the Registrant had undertaken was sufficient to redress his lack of competence. Consequently, the Panel was not satisfied that the Registrant had remediated his lack of competence.

68. In the absence of fully developed insight and remediation, the Panel concluded that there remained a risk of repetition that the Registrant would not review the required annual number of slides or achieve the required level of sensitivities for high grade and all grade abnormalities both as set by the national guidelines. Although the Registrant had achieved the required standards in respect of the 400 training slides, the Panel was not confident that the Registrant could consistently achieve the required standards in respect of actual slides. In the Panel’s judgement, it was this unpredictability which led to a significant risk of harm to patients. His failure to consistently identify at least 95% of high grade and 90% of all grade abnormalities placed increased pressure on the second checker, which in turn meant a potential risk of harm to patients.

69. In all the circumstances, the Panel concluded that the Registrant’s fitness to practise is currently impaired in respect of the public component.

70. In relation to the public component, the Panel was of the view that members of the public need to have confidence that Biomedical Scientists screening cytology slides are competent to review them and appropriately detect high grade and low grade abnormalities. The Panel noted that the national screening programme has been implemented to deal with public health and it considered that public confidence would be damaged if practitioners assigned to screen slides were not competent to consistently detect abnormalities. The Panel concluded that public confidence in the profession would be undermined if no finding of current impairment were made in the particular circumstances of this case.

71. Accordingly, the Panel concluded that the Registrant’s fitness to practise is currently impaired in respect of the public component.

Decision on Sanction:

72. Having determined that the Registrant’s fitness to practise is currently impaired by reason of a lack of competence, the Panel next went on to consider whether it was impaired to a degree which required action to be taken on his registration by way of the imposition of a sanction.

73. The Panel took account of the submissions of Ms Sheridan on behalf of the HCPC and those of the Registrant on his own behalf. Ms Sheridan did not invite the Panel to impose any specific Order, but took the Panel through the Sanctions Policy (the Policy) and identified what she submitted were the relevant factors the Panel should bear in mind in reaching its decision.

74. The Registrant apologised to the Panel for his previous lack of insight into the situation, and said he now understood how his lack of competence had impacted upon colleagues. He said that he was planning to improve his practice and do a three day update course, without which he would be unable to return to practice. The Registrant explained that he had identified such a course that was available in Edinburgh or Manchester. He submitted that if he could improve his practice then that would improve safety for service users. The Registrant said that his understanding was that once he gained employment, he, like any newly appointed employee, would be put through a competency assessment process by his employer to prove that he could work safely at that level.

75. The Panel accepted the advice of the Legal Assessor and exercised its independent judgement. The Panel had regard to the Policy and considered the sanctions in ascending order of severity. The Panel was aware that the purpose of a sanction is not to be punitive but to protect members of the public. In this regard it bore in mind paragraph 10 of the Policy which states:

The primary function of any sanction is to protect the public. The considerations in this regard include:

• any risks the registrant might pose to those who use or need their services;
• the deterrent effect on other registrants;
• public confidence in the profession concerned; and
• public confidence in the regulatory process.

76. The Panel first identified what it considered to be the principal mitigating and aggravating factors in this case.

Mitigating factors:

• The Registrant has engaged with these proceedings and has shown some insight in accepting that he did not meet the required standards and needs to improve his practice with training and refresher courses;
• There is no previous fitness to practise history.

Aggravating factors:

• The failings were serious in that there was a repetition and pattern of underperformance which persisted over a considerable period of time;
• There was a potential risk of harm to patients due to the inconsistency of the Registrant’s ability to detect abnormalities, and the second checker was relied upon to pick up what the Registrant may not have detected.

77. The Panel considered the sanctions available beginning with the least serious. It did not consider the options of taking no further action, mediation or a Caution Order to be appropriate or proportionate in the circumstances of this case. The Panel was of the view that none of these options would be sufficient to protect the public or meet the wider public interest, given that it had identified a risk of repetition in both not meeting the national minimum guidelines for reviewing slides and not consistently detecting abnormalities. The Panel considered that this risk of repetition led to a consequent significant risk of harm to patients.

78. The Panel next considered the imposition of a Conditions of Practice Order. The Panel, in its findings on impairment, had considered that the practice concerns were capable of remediation, but that the Registrant had not yet remedied his practice at this time, having not worked in the field of cytology since 2018. Whilst he had attempted to keep up to date with informal CPD in reading professional journals, the Panel did not consider that this was sufficient. It appeared to the Panel that the Registrant had struggled to remediate pending the fitness to practise proceedings, and his remediation was dependent upon him successfully completing the three day cytology refresher course first.

79. Having heard from the Registrant during the course of the proceedings, the Panel considered that he was genuinely committed to resolving the failings in his practice and had indicated a willingness to undertake refresher courses and training in order to do so. The Panel considered that it would be possible to formulate workable and measurable conditions to enable the Registrant to return to practice and take the necessary remediation steps in order to regain his fitness to practise.

80. In all the circumstances, the Panel concluded that a Conditions of Practice Order would be sufficient to protect the public and satisfy the public interest, while at the same time supporting the Registrant in remedying his fitness to practise.

81. The Panel considered that the length of the order should be for a period of 18 months. Given that the Registrant had been out of the field for a considerable amount of time, the Panel was of the view that 18 months would provide him with the time to successfully complete the three day refresher course to allow him to re-enter the field; to secure a relevant post; and to work meaningfully under the conditions.

82. In order to satisfy itself that a Conditions of Practice Order was the appropriate and proportionate response, the Panel looked at the next level of sanction possible namely a Suspension Order. It had regard to the Registrant’s good level of engagement with these proceedings, his lack of previous fitness to practise history, and his willingness to remedy his failings. The Panel decided that suspension would be wholly disproportionate and unduly punitive, in that it would significantly impede the Registrant from remediating his practice.

83. Accordingly, the Panel imposed a Conditions of Practice Order for a period of 18 months.

Order

The Registrar is directed to annotate the HCPC Register to show that for 18 months from the date that this Order takes effect (the Operative Date), Mr Shanthiratne Semage must comply with the following conditions of practice:

1) Before undertaking any work as a Biomedical Scientist in the field of cytology you must:

A. satisfactorily complete the three day cytology refresher course; and
B. within 14 days of satisfactorily completing the course, forward confirmation of your results to the HCPC.

2) Before undertaking any work as a Biomedical Scientist in the field of cytology, you must:

A. satisfactorily complete the training and competency programme of the organisation for whom you are working for; and
B. within 14 days of satisfactorily completing the programme, forward confirmation of your results to the HCPC.

3) Upon commencement of employment in the field of cytology, you must place yourself and remain under the supervision of an HCPC registered workplace supervisor of a minimum of Band 7 and supply details of your workplace supervisor to the HCPC within three months of commencing employment. You must attend upon that supervisor as required and follow their advice and recommendations.

4) Prior to any review, you must obtain and send to the HCPC a report from your workplace supervisor commenting on your practice as a Biomedical Scientist in the field of cytology. The report should include information regarding your ability to meet the national guidelines for high grade and all grade sensitivities and minimum annual numbers of cytology slides reviewed.

5) You must promptly inform the HCPC if you cease to be employed by your current employer or take up any other or further employment.

6) You must promptly inform the HCPC of any disciplinary proceedings taken against you by your employer.

7) You must inform the following parties that your registration is subject to these conditions:

A. any organisation or person employing or contracting with you to undertake professional work;
B. any agency you are registered with or apply to be registered with (at the time of application); and
C. any prospective employer (at the time of your application).

8) You will be responsible for meeting any and all costs associated with complying with these conditions.

Notes

Right of Appeal:
You may appeal to the High Court in England and Wales the Panel’s decision and the order it has made against you.

Under Article 29(10) of the Health Professions Order 2001, any appeal must be made within 28 days of the date when this notice is served on you. The Panel’s order will not take effect until the appeal period has expired or, if you appeal, until that appeal is disposed of or withdrawn.

Interim Order:

Application for an Interim Order

1. As the Conditions of Practice Order will not take effect for at least 28 days, or if the Registrant appeals, until the appeal is withdrawn or otherwise finally disposed of, the Panel was invited by Ms Sheridan to make an Interim Conditions of Practice Order in the same terms as the substantive order under article 31(2) of the Health Professions Order 2001. She submitted that an interim order was necessary to protect the public and was otherwise in the public interest.

Panel’s Decision

2. Having heard and accepted the advice of the Legal Assessor, the Panel decided that an Interim Order was necessary to protect the public for the same reasons as set out in the substantive determination, namely that the Registrant’s lack of competence had been repeated and prolonged; he has not remediated his practice; and so the risk of repetition remains, with the consequent risk of harm to patients.

3. The Panel also concluded that an Interim Order was required in the public interest, for the same reasons as set out in the substantive determination, namely in order to maintain public confidence in the profession that Biomedical Scientists appointed to the NHS National Screening Programme have the level of competency to meet the national guidelines.

4. The Panel decided to impose interim conditions in the same terms as set out in the substantive Conditions of Practice Order, having been satisfied that the conditions formulated would be sufficient to protect patients and address the public interest.

5. The Panel decided to impose the interim conditions for a period of 18 months, given that if the Registrant does appeal, it may take some time for the appeal to be dealt with.

6. The Interim Order will expire (if no appeal is made against the Panel’s decision and Order) upon the expiry of 28 days; or (if an appeal is made against the Panel’s decision and Order) upon the final determination of that appeal, subject to a maximum period of 18 months.

Interim Conditions of Practice Order:

The Panel makes an Interim Conditions of Practice Order under Article 31(2) of the Health Professions Order 2001, the same being necessary to protect members of the public and being otherwise in the public interest.

This order will expire: (if no appeal is made against the Panel’s decision and Order) upon the expiry of the period during which such an appeal could be made; (if an appeal is made against the Panel’s decision and Order) the final determination of that appeal, subject to a maximum period of 18 months.

Hearing History

History of Hearings for Mr Shanthiratne Semage

Date Panel Hearing type Outcomes / Status
10/05/2021 Conduct and Competence Committee Final Hearing Conditions of Practice
12/04/2021 Conduct and Competence Committee Final Hearing Adjourned part heard