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As a registered Biomedical Scientist (BS66080) your fitness to practise is impaired by reason of misconduct. In that:
1. Whilst employed at Medical Diagnosis Limited:
a. On 17 January 2018, you reported the result of a Human T-lymphotropic virus (HTLV) test as positive when the result was in fact negative;
b. On or around 15 March 2018, you incorrectly altered results which had been entered on or around 13 March 2018 in that you reported a normal male karyotype result for a female patient.
c. On or around 12 June 2018, you reported an incorrect result in that you reported the dilution result and not the actual hormone titre.
2. The matters set out in Particular 1a) – 1c) above constitute misconduct.
3. By reason of your misconduct your fitness to practise is impaired.
Decision on Service of Notice of Hearing
1. At the start of the hearing, the Panel was informed that the Registrant was not in attendance, and that notice of this hearing had been sent to her registered email address on 18 December 2020.
2. The Panel received the advice of the legal assessor.
3. The Panel took into account that the email provided details of the allegations (as proposed to be amended on 3 August 2020), the time, dates and arrangements for the hearing, and, amongst other things, information about the Registrant’s right to attend, be represented and call evidence, as well as the Panel’s power to proceed in her absence.
4. In the light of all of the information available, the Panel was satisfied that the Registrant had been served with notice of this hearing in accordance with the requirements of Rules 3 and 6 of the Health and Care Professions Council (Conduct and Competence Committee) (Procedure) Rules 2003 (“the Rules”).
Decision on proceeding in the absence of the Registrant
5. Mr Bridges invited the Panel to exercise its discretion and proceed in the absence of the Registrant. He referred the Panel to the Registrant’s completed Response Pro-Forma and Pre-hearing Information Form signed by the Registrant on 2 October 2020, where she indicated that she did not plan to attend this hearing nor be represented at it, and made admissions to the facts of the allegations.
6. Mr Bridges submitted that there was sufficient evidence to demonstrate that that the Registrant has voluntarily absented herself and reminded the Panel that there was a public interest in disposing of the matter expeditiously and that there was a witness in attendance for this hearing who was ready to assist the Panel.
7. Mr Bridges further submitted that there was nothing to indicate that an adjournment would secure the Registrant’s attendance and the Panel should proceed in the public interest and in the interest of the expeditious disposal of the matter.
8. The Panel received the advice of the legal assessor with regard to Rule 11 which states:
“Where the registrant is neither present nor represented at a hearing, the Committee may nevertheless proceed with the hearing if it is satisfied that all reasonable steps have been taken to serve the notice of the hearing under Rule 6(1) on the registrant”
9. The legal assessor reminded the Panel that whilst it had the discretion to proceed in the absence of the Registrant, it should exercise the utmost care and caution in considering the application and have regard to the overall interests of justice and fairness to all parties.
10. The Panel took into account the Registrant’s indication in her Response Pro-Forma and Pre-hearing Information Form dated 2 October 2020 that she did not plan to attend this hearing and that she admitted the facts alleged. In reaching its decision, the Panel had regard to the submissions of Mr Bridges and the advice of the legal assessor. It also had regard to the overall interests of justice and fairness to all parties. It noted that:
- no application for an adjournment had been made by the Registrant;
- there was no reason to suppose that adjourning would secure the Registrant’s attendance at some future date;
- the witness for the HCPC had been warned and was present to give evidence
- the charges which raise public protection concerns relate to allegations which date back to 2018;
- further delay may have an adverse effect on the ability of the witness to accurately recall events;
- there is a strong public interest in the expeditious disposal of the case.
11. The Panel concluded that the Registrant had chosen voluntarily to absent herself. Having weighed the interests of the Registrant with those of the HCPC and the public interest in an expeditious disposal of the matter, the Panel determined that it was fair and appropriate to proceed in the absence of the Registrant.
Amendment of the allegations
12. On behalf of the HCPC Mr Bridges made a formal application to amend the allegations before the Panel. He submitted that the proposed amendments provided greater clarity whilst not adding materially to the misconduct alleged or prejudicing the Registrant’s interests. He referred the Panel to the correspondence dated 3 August 2020 in which the HCPC wrote to the Registrant with clear notice of the proposed amendments to the allegations.
13. The Panel received the advice of the legal assessor.
14. The Panel determined to allow the amendments proposed on behalf of the HCPC. The Panel took into account that the Registrant had received clear and specific notice of the proposed amendments in correspondence on 3 August 2020 and had responded to those amended allegations in her Response Pro-Forma and Pre-Hearing Information Form dated 2 October 2020. The Panel considered that the proposed amendments were for clarification and did not materially alter the nature of the allegations; nor did the proposed amendments place the Registrant at any material disadvantage.
Decision on conducting part of the hearing in private
15. The Panel of its own motion invited submissions from Mr Bridges as to whether, in light of sensitive information regarding the Registrant’s health, it was appropriate for any part of the hearing that touched upon such information to be conducted in private.
16. On behalf of the HCPC, Mr Bridges expressed agreement with the approach proposed.
17. The Panel received the advice of the legal assessor.
18. The Panel considered Rule 10(1)(a) of the Rules which states:
“At any hearing…the proceedings shall be held in public unless the Committee is satisfied that, in the interests of justice or for the protection of the private life of the registrant, the complainant, any person giving evidence or of any patient or client, the public should be excluded from all or part of the hearing;”
19. The Panel bore in mind the public interest in open justice and weighed against it the interests of the Registrant and protection of her private life. It determined there was a compelling reason to hear any part of this matter which touched upon sensitive information regarding the Registrant’s health in private. It determined to rule on whether or not to go into private session as and when such information was raised.
20. The Registrant is a Biomedical Scientist who was employed by Medical Diagnosis Limited (“the Company”), a private clinical pathology laboratory, between December 2007 and July 2018. The Company is commissioned to conduct and further commission a wide variety of tests on behalf of the patients of its referring clinics. The Company is required to meet the quality standard of ISO15189 and its results are internally and externally audited.
21. It is alleged that between January 2018 and June 2018, there were three incidents at the Company involving the Registrant allegedly failing to record and report laboratory results accurately and in one instance amending a result from a correct to an incorrect recording.
22. Following the first incident in January 2018, the Registrant offered a written apology by email to the clinic to whom the incorrect laboratory results had been conveyed. Following the second incident in March 2018, the Registrant attended a meeting to discuss matters and offered a written apology to the Company. Following the third incident in June 2018, the Registrant was subject to an investigation and disciplinary process which resulted in her dismissal in July 2018.
23. A referral to the HCPC was made by the Company on 6 September 2018.
Decision on Facts
24. In reaching its decisions on the facts, the Panel considered all the evidence adduced in the case together with the submissions made by Mr Bridges on behalf of the HCPC and the written information submitted by the Registrant in her Response Pro-Forma and Pre-Hearing Information Form dated 2 October 2020.
25. The Panel heard and accepted the advice of the legal assessor.
26. The Panel was aware that the burden of proof rests on the HCPC, and that the standard of proof is the civil standard, namely the balance of probabilities. This means that the facts will be proved if the Panel is satisfied that it was more likely than not that the incidents occurred as alleged.
27. The Panel heard oral evidence from one witness called by the HCPC, Dr George Xynopoulos who is the Chief Executive Officer of the Company.
28. The Panel first considered the overall credibility and reliability of the oral evidence it heard.
29. The Panel found Dr Xynopoulos to be a credible witness who was doing his best to assist the Panel. It found him to be appropriately concerned for the standard of work done at the Company, not just because a failure in standard would impact on the Company’s business but also because it has a potential impact on the health and safety of patients whose laboratory results are crucial to the determination of the treatment they require. The Panel considered Dr Xynopoulos to be a conscientious witness, albeit in some instances he was not fully familiar with the internal record-keeping practices of the Company. However, overall, the Panel considered his evidence to be measured and reliable.
30. The Panel took into account that the Registrant had indicated in her Response Pro-Forma and Pre-Hearing Information Form dated 2 October 2020 that she fully admitted all the factual allegations, and that since then she has offered no alternative or additional account to the Panel. Notwithstanding these admissions the Panel reminded itself that it was for the HCPC to prove the allegations to the requisite standard.
31. The Panel considered each charge and made the following findings:
Allegation 1a (as amended):
On 17 January 2018, you reported the result of a Human T-lymphotropic virus (HTLV) test as positive when the result was in fact negative;
This allegation is found proved
32. In reaching this decision, the Panel took into account the evidence of Dr Xynopoulos that an incorrect test result for HTLV was released to the referring clinic by the Registrant on 17 January 2018, and that three days later a nurse from the referring clinic telephoned the Company and asked what the implication of a positive result would be for the patient in terms of treatment. The error was discovered when the result was checked following this call and the report was subsequently amended.
33. Dr Xynopoulos confirmed it was established that the Registrant had made a “typing error” in transferring the result onto the Company’s computer system. The Panel was satisfied that the Company’s record-keeping practices and audit trail meant it was possible to confirm that the Registrant had been responsible for the incorrect entry of the result. The Panel noted that, after a discussion with the Registrant, she emailed the referring clinic on 25 January 2018 to apologise for her error.
34. The Panel was satisfied that this evidence, together with the general admission made by the Registrant in her Response Pro-Forma and Pre-Hearing Information Form dated 2 October 2020, was sufficient to prove this charge on the balance of probabilities.
Allegation 1b (as amended):
“On or around 15 March 2018 you incorrectly altered results which had been entered on or around 13 March 2018 in that you reported a normal male karyotype result for a female patient”
This allegation is found proved
35. In reaching this decision, the Panel took account of the evidence of Dr Xynopoulos and the audit trail of test results placed before it. The Panel heard that the correct karyotype test results had been entered into the Company computer system by another biomedical scientist employed by the Company on 13 March 2018, but subsequently had been erroneously altered by the Registrant on 15 March 2018. The erroneous results were identified by the referring clinic, which then took the matter up with the Company prior to the results being released to the patient.
36. The Panel heard that on 28 March 2018 Dr Xynopoulos spoke with the Registrant regarding the alteration to the test results and that she was unable to explain her actions. The Panel had regard to an email written by the Registrant following that conversation, in which she acknowledged her error. The error was logged on the Company’s Corrective and Preventative Actions report which was also before the Panel.
37. The Panel was satisfied that this evidence, together with the general admission made by the Registrant in her Response Pro-Forma and Pre-Hearing Information Form dated 2 October 2020, was sufficient to prove this charge on the balance of probabilities.
Allegation 1c (as amended):
“on or around 12 June 2018, you reported an incorrect result in that you reported the dilution result and not the actual hormone titre”
This allegation is found proved
38. In reaching this decision, the Panel took account of the evidence of Dr Xynopoulos who explained that the referring clinic asked the Company to provide an exact hormone titre for a patient who was preparing to undertake IVF treatment. This is a standard in-house procedure where a sample is diluted prior to testing by a particular factor, and once the diluted sample has been tested, the result is multiplied by the same factor to produce an accurate result; and a procedure with which the Registrant would have been very familiar in the course of her employment.
39. In this particular instance Dr Xynopoulos told the Panel that the Registrant made three dilutions to the patient’s sample and conducted the appropriate testing upon it, but on reporting the result she failed to multiply the test result by the appropriate dilution factor, so that the result validated by the Registrant was erroneously low.
40. The Panel heard that the error was identified by the referring clinic only after the patient in question had been provided with hormonal treatment based on the erroneous result which had produced an unexpected clinical response. This led to the patient’s doctor querying the result and the mistake was uncovered.
41. The Panel had sight of the Company’s internal disciplinary investigation documents and notes of the disciplinary meeting held with the Registrant. It took account of the Company’s Corrective and Preventative Actions report and the auditing abilities of the Company to ascertain which employee was responsible for entering test results.
42. The Panel was satisfied that this evidence, together with the general admission made by the Registrant in her Response Pro-Forma and Pre-Hearing Information Form dated 2 October 2020, was sufficient to prove this charge on the balance of probabilities.
Decision on Grounds
43. The Panel considered the matter of misconduct. The Panel was mindful that whether the facts proved amount to misconduct is entirely for the Panel’s professional judgment and there is no burden or standard of proof.
44. The Panel heard submissions from Mr Bridges. He referred the Panel to the case of Roylance v GMC  UKPC 16 where Lord Clyde commented:
“Misconduct is a word of general effect, involving some act or omission which falls short of what would be proper in the circumstances. The standard of propriety may often be found by reference to the rule and standards ordinarily required to be followed by a medical practitioner in the particular circumstances.” [331B-E]
45. The Panel also bore in mind the comments of Leggat J (endorsing the advice of the legal assessor in the substantive hearing) in Johnson and Maggs v NMC (No 2)  EWHC 2140 (Admin) that:
“To find misconduct however, the Committee had been advised and had accepted that the failure had to be such that it would be seen as “deplorable” by fellow practitioners and as involving a serious departure from acceptable standards”.
46. The Panel heard and accepted the advice of the legal assessor.
47. The Panel considered each allegation in turn.
48. With respect to allegation 1a, the Panel determined that the simple transcription error made by the Registrant was understandable but her failure to check her work for errors and ensure accuracy was not acceptable and fell far short of the standard expected of her.
49. The consequence of her behaviour was that an inaccurate result had been sent to the clinic and it was only good fortune that prevented it being wrongly communicated to the patient in question, who would have undoubtedly suffered anxiety in being told that an infection was present. Further, it might have resulted in unnecessary treatment being delivered to the patient.
50. With respect to allegation 1b, the Panel determined that the alteration that the Registrant made to the karyotype test results, from a correct result to an incorrect result, without explanation or rationale, was serious in that it resulted in wrong information being delivered to the referring clinic. Again, it was the vigilance of the referring clinic that brought the mistake to light. It was not possible to infer that the Registrant had, in this instance, made a simple transcription error because the result had been entered correctly by her colleague, and she must deliberately have decided to amend it for no evident reason.
51. Given the importance of accurate management of sensitive patient data and the implications for patient trust and confidence in misreporting of test results, the Panel determined that the Registrant’s behaviour in this instance fell far short of what would be expected of her as a registered professional.
52. With respect to allegation 1c, the Panel determined that this was the most serious example of the Registrant’s behaviour. In this case, the Registrant’s failure to multiply the hormone titre result by the appropriate factor had in fact resulted in a patient receiving incorrect hormonal treatment, and resulted in a response that was quadruple that which her treating clinician had anticipated. It brought with it a significant risk that the patient might suffer ovarian hyperstimulation syndrome (“OHS”), which is a serious condition. Whilst the Panel had no evidence to confirm that the patient did suffer OHS, the fact the patient was placed at such risk was sufficiently grave and represented a risk of real and significant harm.
53. The behaviour was all the more unacceptable as the original test result (before titration) was a higher figure than that entered by the Registrant after titration, which meant it should have been obvious to her that the post-titration figure was inaccurate and should have prompted her to review her work.
54. In this instance the Registrant’s conduct fell far below that which would be expected of her.
55. In all the circumstances, the Panel determined that the Registrant’s behaviour as found proved did amount to misconduct.
Decision on Impairment
56. The Panel next went on to decide if, as a result of this misconduct, the Registrant’s fitness to practise is currently impaired.
57. The Panel heard submissions from Mr Bridges on behalf of the HCPC.
58. The Panel heard the advice of the legal assessor.
59. The Panel reminded itself that the determination of current impairment is a matter for its professional judgment.
60. In this regard the Panel considered the judgment of Mrs Justice Cox in the case of Council for Healthcare Regulatory Excellence v (1) Nursing and Midwifery Council (2) Grant  EWHC 927 (Admin) in reaching its decision, in particular paragraph 74 where she said:
“In determining whether a practitioner’s fitness to practise is impaired by reason of misconduct, the relevant Panel should generally consider not only whether the practitioner continues to present a risk to members of the public in his or her current role, but also whether the need to uphold proper professional standards and public confidence in the profession would be undermined if a finding of impairment were not made in the particular circumstances”
61. The Panel also bore in mind the guidance of Mrs Justice Cox at paragraph 76 that Panels should heed the approach of Dame Janet Smith in the Fifth Report from the Shipman enquiry:
Do our findings of fact in respect of…misconduct…show that [the Registrant’s] fitness to practise is impaired in the sense that s/he:
(a) Has in the past acted and/or is liable in the future to act so as to put a patient or patients at unwarranted risk of harm; and/or
(b) Has in the past brought and/or is liable in the future to bring the …profession into disrepute; and/or
(c) Has in the past breached and/or is liable in the future to breach one of the fundamental tenets of the ..profession; and/or
(d) Has in the past acted dishonestly and/or is liable to act dishonestly in the future.
62. The Panel considered that, in the present case, limbs (a), (b) and (c) are engaged.
63. The Panel noted that, whilst the Registrant had offered an apology in the instance of the behaviour found proved at allegations 1a. and 1b., which may indicate a degree of remorse, there was limited evidence that the Registrant had insight into her misconduct.
64. The very limited engagement of the Registrant meant the Panel lacked evidence of insight and remediation. The Registrant had submitted no evidence of reflection or targeted professional development. The Panel could not be satisfied that the Registrant fully understood the gravity of her behaviour nor that she had taken any or sufficient steps to remedy her practice.
65. In those circumstances, the Panel could not be satisfied that the risk of repetition of the Registrant’s behaviour was low.
66. The Panel therefore decided that a finding of impairment is necessary on the grounds of public protection.
67. The Panel bore in mind the role of the regulator in upholding and protecting the wider public interest, which includes promoting and maintaining public confidence in the profession and upholding the proper professional standards for members of the profession.
68. The Panel determined that, in this case, a finding of current impairment on public interest grounds was also required. The Registrant demonstrated significant failings in her practice which brought a risk of harm to the public, and public confidence in the profession and the regulatory process would be undermined if the Registrant were not found to be currently impaired.
69. Having regard to all of the above, the Panel was satisfied that the Registrant’s fitness to practise is currently impaired.
Decision on Sanction
70. The Panel decided to make a Suspension Order for a period of six (6) months.
71. In reaching this decision, the Panel has had regard to all the evidence that has been adduced in this case. It heard submissions from Mr Bridges on behalf of the HCPC, who indicated that the HCPC was neutral in its approach to the question of sanction.
72. The Panel heard the advice of the legal assessor.
73. The Panel bore in mind that any sanction imposed must be appropriate and proportionate and, although not intended to be punitive in its effect, may have such consequences. The Panel reminded itself that it must strike a balance between the interests of the Registrant and those of the public; but that the individual’s interests do not outweigh the public interest. The Panel was mindful that it should impose the least restrictive sanction that meets with the risks identified in the case.
74. The Panel had careful regard to the HCPC’s Sanctions Policy. It recognised that the decision on sanction is a matter for the panel, exercising its own independent professional judgment.
75. The Panel took into account the following aggravating and mitigating factors:
- The Registrant committed a series of errors in a period of 5 months
- One of those errors could have resulted in significant and needless anxiety being caused to a patient and/or that patient receiving unnecessary medical treatment
- One of those errors did result in a patient being placed at significant risk of harm as a consequence of receiving inappropriate treatment based on the Registrant’s error
- The Registrant’s engagement in the regulatory process has been limited
- The Registrant has not demonstrated any sufficient or developing insight into the failings in her practice and has not produced any evidence of having reflected upon them
- The Registrant has not submitted any evidence of remediation of her practice, nor evidence of having undertaken appropriately targeted continuing professional development
- The Registrant admitted to all of the facts alleged in her Response Pro-Forma and Pre-hearing Information Form dated 2 October 2020
- The Registrant was experiencing menopausal symptoms which she found burdensome
76. The Panel first considered whether to take no action but concluded that this would be inappropriate in view of the seriousness of the case. The Panel also determined it would be neither proportionate nor in the public interest to take no further action.
77. The Panel next considered whether a Caution Order was appropriate in the circumstances. It took into account the Sanctions Policy, which states that a Caution Order is likely be appropriate where the issue is isolated, limited, or relatively minor in nature; there is a low risk of repetition; the Registrant has shown good insight; and the Registrant has undertaken appropriate remediation.
78. The Panel considered that the behaviour underlying its finding of misconduct was not relatively minor in nature and that the risk of repetition could not be said to be low; nor had the Registrant demonstrated more than limited insight or appropriate remediation. In those circumstances the Panel determined a Caution Order was neither proportionate, nor in the public interest, nor would it protect the public.
79. The Panel next considered whether placing Conditions of Practice on the Registrant’s registration would be a sufficient and appropriate response. The Panel was mindful that any conditions imposed must be proportionate, measurable and workable.
80. The Sanctions Policy indicates that a Conditions of Practice Order is likely to be appropriate where the issue is isolated, limited, or relatively minor in nature; there is a low risk of repetition; the registrant has shown good insight; and the registrant has undertaken appropriate remediation.
81. At paragraph 107 of the Sanctions Policy it states:
“Conditions will only be effective in cases where the registrant is genuinely committed to resolving the concerns raised and the panel is confident they will do so. Therefore, conditions of practice are unlikely to be suitable in cases in which the registrant has failed to engage with the fitness to practise process or where there are serious or persistent failings.”
82. The Panel considered that it may be possible to devise workable Conditions of Practice that provided for stringent supervision of the Registrant’s work. However, the Panel took the view that such conditions as would be effective would not be realistically practicable, given they would need to be onerous so as to ensure they fulfilled their purpose of public protection.
83. The Panel bore in mind that the Registrant had demonstrated limited insight and that the risk of repetition was not found to be low. It was also mindful that the Registrant’s lack of engagement in the regulatory process was such that it could not be confident that she was committed to resolving the concerns raised.
84. The Panel therefore determined in all the circumstances that a Conditions of Practice Order was not an appropriate, proportionate or workable order for the protection of the public and was not in the public interest.
85. The Panel next considered whether to make a Suspension Order.
86. The Panel determined that a Suspension Order would provide an appropriate response to the seriousness of the Registrant’s misconduct. It would protect the public for its duration; and it would mark the public interest in upholding professional standards and maintaining public confidence in the profession and the regulator.
87. The Panel went on to consider whether a Striking Off order was an appropriate and proportionate measure but determined that the misconduct identified, whilst serious, was not such that it rendered the Registrant unsuitable to remain on the register; and that a Suspension Order was sufficient to protect the public and maintain public confidence. In those circumstances it would be wholly disproportionate to impose a Striking Off order.
88. The Panel determined that the appropriate duration of the Suspension Order was six months. It considered that this period of suspension was proportionate to the risks identified and would provide time and an opportunity for the Registrant to demonstrate development in her insight and remediation before any review hearing.
89. The Panel considered that any panel conducting a review hearing may be assisted by the following:
- The Registrant’s full engagement in the review process and attendance at any hearing
- The Registrant providing a reflective piece addressing her misconduct
- The Registrant providing up-to-date information about her continuing professional development; and in particular any targeted professional development and training that addresses the deficiencies in her practice identified by this Panel
- Evidence of the Registrant seeking to maintain and enhance her skills in a laboratory environment in a capacity that does not require professional registration.
ORDER: The Registrar is directed to suspend the registration of Mrs Malgorzata Kochanek for a period of 6 months from the date this Order comes into effect.
1. On behalf of the HCPC, Mr Bridges applied for an Interim Suspension Order for a period of 18 months and asked the Panel to consider the application in the absence of the Registrant.
2. Mr Bridges submitted that the Registrant had been put on notice of the potential for an application for an Interim Order in the Notice of Hearing dated 3 August 2020 which was served upon her.
3. The Panel heard the legal advice of the legal assessor.
4. The Panel determined to proceed in the absence of the Registrant. It was satisfied that notice had been given to the Registrant of the potential for such an application to be made. The Panel determined that the Registrant had voluntarily absented herself from this hearing and that there were no grounds to think that an adjournment would resolve her absence. The Panel was mindful of the need for expeditious disposal of the application.
5. In making the substantive application, Mr Bridges submitted that, given this Panel’s findings of misconduct, the protection of the public and the public interest required the making of an Interim Suspension Order. The Interim Suspension Order would mean that the Registrant is suspended with immediate effect and for the duration of any appeal. He submitted the period of 18 months was appropriate to cover the likely duration of any appeal.
6. The Panel considered the balance between the interests of the Registrant and the interests of the public. The Panel took account of the impact of an Interim Suspension Order on the Registrant, but considered this was outweighed by the public interest. Given the Panel’s findings of misconduct involving a direct risk of harm to a member of the public, and the risk of repetition, it considered that an Interim Suspension Order was necessary both on the grounds of protection of the public and the public interest. It considered that an informed member of the public would be concerned if no immediate action were taken to protect the public from the risk of harm.
7. The Panel determined that it was appropriate to make an Interim Suspension Order for a period of 18 months, bearing in mind the likely time necessary to dispose of any appeal that the Registrant may bring.
History of Hearings for Malgorzata Kochanek
|Outcomes / Status
|Conduct and Competence Committee
|Conduct and Competence Committee