During the course of your employment as a Biomedical Scientist by The
Christie Pathology Partnership, you:
1. In relation to Colleague 'A' and Colleague 'B’ failed to:
a. maintain adequate training for blood transfusion;
b. maintain appropriate training records
2. Between November 2013 and July 2014, did not ensure that the appropriate standards were maintained in relation to the cleaning and/or decontamination of:
c. Incubators; and
d. Other equipment.
3. Between November 2013 and July 2014, did not ensure that regular testing of the Blood Transfusion alarm system was undertaken.
4. Between January 2014 and June 2014, did not ensure availability of the appropriate stock levels of:
a. Diasure QC material (for ID Gelstation);
b. 20% Albumin solution; and
5. In April 2014, following a decontamination procedure, you and/or a member of your team, put the Diamed Gelstation back into routine use despite having no Anti-S to ensure that no bleach remained present.
6. Between 23 April 2014 and 24 April 2014, did not check the QC logs and sign them off appropriately.
7. The matters described in paragraphs 1 - 5 constitute misconduct and/or lack of competence.
8. By reason of your misconduct and/or lack of competence, your fitness to practise is impaired.
1. Ms Hema Shah (“the Registrant”) is registered with the HCPC as a Biomedical Scientist and she was employed as a Band 7 Senior Biomedical Scientist in the Blood Transfusion Department of the Christie Pathology Partnership (“the Christie”). She was responsible for the day to day supervision of bio-medical staff working in the Blood Transfusion Laboratory. In July 2014 managers had concerns about the standard of her work. Those concerns led to the Christie making a referral to the HCPC regarding the Registrant’s fitness to practise.
2. The Registrant has not attended this hearing. The Panel was satisfied that notice of today’s hearing had been served by post on the Registrant at the address given by the Registrant for HCPC registration purposes. That notice had been sent on 9 June 2016. A copy of the notice was also sent by email to the Registrant. The Panel was satisfied that the HCPC had taken all reasonable steps to serve the notice of hearing and that there had been good service of that document.
3. The Panel had to decide whether or not to proceed in the absence of the Registrant and took into account the HCPC Practice Note “Proceeding in the Absence of the Registrant” and the advice of the Legal Assessor. The Panel took into account that a decision to proceed in the absence of a registrant should be taken only after exercising the utmost care and caution. The Panel recognised that the Registrant would be at a disadvantage by not being present. The Panel asked the Hearings Officer to try to make telephone contact with the Registrant. The only telephone number held by the HCPC was a previous work number so no telephone contact could be made. However, the Panel noted that the Registrant had last participated in these proceedings in December 2014 when she sent an email to the HCPC to set out her representations in respect of the allegation as it then stood. There was no indication that if this hearing were to be adjourned that the Registrant would attend at any replacement hearing. The Registrant had not sought an adjournment. The Panel was satisfied that the Registrant had voluntarily waived her right to attend. It is in the public interest that allegations of this kind are properly progressed. In all the circumstances the Panel decided it was appropriate to proceed in the absence of the Registrant. The Panel drew no adverse inferences from the Registrant’s non-attendance.
4. At the commencement of the hearing Ms Partos made an application to amend some of the particulars within the allegation. The detail of the proposed amendments had been provided with a letter sent to the Registrant on 13 June 2016. The Registrant had made no comment or objection concerning the proposed amendments. The Panel was satisfied that the essence of the allegation that had originally been asserted was being maintained. The amendments related simply to some of the supporting detail. There was no disadvantage caused to the Registrant by the application. The Panel allowed the application and the particulars of the allegation as amended are shown in this Decision.
5. The HCPC case relied upon the evidence of three witnesses who were employees of the Christie at the relevant times:
Witness 1 – Currently General Manager at the Christie and employed there as Blood Sciences Service Manager/Deputy Chief Operating Officer during the relevant period.
Colleague A - Biomedical Scientist
Colleague B - currently Biomedical Scientist and Medical Laboratory Assistant during the relevant period.
Decision on facts
6. The Panel has taken into account all that the Registrant said in her email dated 6 December 2014 and in interview during disciplinary investigations at the Christie.
7. The Panel makes the following findings of fact on the balance of probabilities. Those findings deal, first, with a matter of general application and, secondly, with each of the particulars in the allegation.
8. The Panel has considered the general reliability of the witnesses called in support of the HCPC case. The Panel is satisfied that Witness 1 was consistent, reliable, credible and open in her evidence. Colleague A was consistent and credible in what she said. Colleague B was an honest witness but, because of the passage of time, was not always able to be clear on the dates and details of events.
9. Turning to the specific particulars the Panel makes the following findings.
10. Particular 1
Between April 2014 to July 2014, in relation to Colleague ‘A’ and/or Colleague ‘B’ failed to:
a. maintain adequate training for blood transfusion; and/ or;
b. maintain appropriate training records
11. The Panel finds particular 1a proved in as much as it applies to Colleague A. There was a duty on the Registrant to train staff. Her job description made clear that she was to participate in staff training. The Panel has noted the record made by Witness 1 on 3 June 2014 and 17 June 2014 in this respect. That note confirms that training was not being provided consistently in respect of Colleague A and, further, that the Registrant was not taking a sufficiently active role in training staff as she should have done. It is clear to the Panel that the Registrant was aware that she should have carried out training duties as she had done so in the past for other staff.
12. In respect of Colleague B the evidence of that witness was that he received on the job training in certain functions and once he had become competent in that function he would learn another task. That was an approach that was supported by the Registrant’s written representations. Therefore 1(a) is not proved in respect of Colleague B.
13. Particular 1(b) is proved. It was the responsibility of the Registrant to sign off the training provided to staff including Colleagues A and B. It is clear from the response by the Registrant to this point in the disciplinary investigation interview that she had not carried out this task. She maintained that recording forms were not available but the Panel is satisfied on the evidence of Witness 1 that they were. Further, the Registrant failed to inform Witness 1, her line manager at the time that training was not being properly recorded.
14. Particular 2
Between November 2013 and July 2014, did not ensure that the appropriate standards were maintained in relation to the cleaning and/or decontamination of:
d. Agitators; and/or
15. The Panel finds all of these matters proved. Both a cleaning log for all equipment and individual logs for each item of equipment should have been maintained. There was a period of time since Colleague A’s departure from the department until the appointment of Colleague B when the staff who would usually carry out the task were not present. The Panel recognises there are some isolated records which demonstrate some cleaning had been carried out. In the Registrant’s written submissions she maintained that once Colleague A had left and before Colleague B joined cleaning was “relegated” to other staff. She also said that she had trained Colleague B to do it but she hadn’t checked if he was doing it. There is no record of the necessary cleaning having been carried out on a regular basis, as detailed in the Standard Operating Procedure “Cleaning Blood Bank Equipment” dated 30th September 2011.
16. Particular 3
Between November 2013 and July 2014, did not ensure that regular testing of the Blood Transfusion alarm system was undertaken.
17. The Panel finds this matter as proved. The practice was to check alarm systems when equipment was being cleaned. The finding of the Panel above was that equipment was not cleaned on a regular basis. The Panel is satisfied on the balance of probabilities and from the alarm testing log in the evidence bundle that there was not regular testing of the alarm system.
18. Particular 4
Between January 2014 and June 2014, did not ensure availability of the appropriate stock levels of:
a. Diasure QC material (for ID Gelstation); and/or
b. Anti- S.
The Panel finds particular 4a not proved but particular 4b is proved.
19. Regarding particular 4a the Panel does not find this proved as it relates solely to Diasure QC, which became unavailable in 2013, rather than one of its substitutes.
20. Regarding particular 4b the Registrant in interview accepted she had difficulty sourcing the material. But the issue here is that she allowed stock to run too low before ordering it. She did not take the proactive action of checking stock levels as she should have done.
21. Particular 5
On 23/24 April 2014, following a decontamination procedure, you and/or a member of your team, put Diamed Gelstation back into routine use despite having no Anti- S to ensure that no bleach remained present.
22. This particular is proved. The documentation provided shows clearly that a Diamed Gelstation was put back into routine use despite having no Anti-S and, further, that the Registrant was responsible.
23. Particular 6
Between 23 April 2014 and 24 April 2014, did not sign QC logs off appropriately in that you recorded the QC result as a pass when it failed.
24. This concern is closely connected to the previous particular. Again the documentation shows that the Registrant was involved and had responsibility for recording a test as a pass when it was a fail. This particular is proved.
Decision on Grounds
25. In assessing misconduct and lack of competence the Panel has taken into account the following factors while reminding itself that it is a matter for its own professional judgment.
· Misconduct: the conduct must be serious and involve some act or omission which falls short of what would be proper in the circumstances.
· Lack of competence: arises where a registrant has repeatedly or persistently failed to reach the standard of competence expected. It usually relates to a lack of knowledge, skill or judgment as demonstrated through a fair sample of a registrant’s work.
26. On this basis and taking into account the advice of the Legal Assessor that each particular found proved needs to be considered separately, the Panel concluded that:
· Particular 1a and b indicate the Registrant fell below the required standards but the short comings were not sufficiently serious to amount to misconduct. The Panel noted that Colleague A was receiving training from other colleagues. In addition there was some responsibility on Colleagues A and B to keep their own training records as set out in The Blood Sciences Training and Competency Assessment Policy which was issued in January 2014.
· Particular 2a-e The Panel considered that the potential contamination and/or loss of valuable blood products means that this is serious enough to constitute misconduct.
· Particular 3 The Panel considered that the potential contamination and/or loss of valuable blood products means that this is serious enough to constitute misconduct.
· Particular 4b Without the necessary stock, the analyser might not be properly decontaminated. This would potentially have serious consequences for patients and, as such, constitutes misconduct.
· Particulars 5 and 6 The consequences of signing off and putting a contaminated analyser back into routine use would mean it may not pick up antibodies present in patient samples and thus give false results. Both of these are serious enough to constitute misconduct.
27. The Panel is satisfied that the actions of the Registrant amount to breaches of HCPC Standards as follows:
Standards of conduct, performance and ethics:
7. You must communicate properly and effectively with service users and other practitioners.
8. You must effectively supervise tasks that you have asked other people to carry out.
10. You must keep accurate records.
Standards of proficiency:
1a5 be able to exercise a professional duty of care
1a6 be able to practise as an autonomous professional, exercising their own professional judgement
2b5 be able to maintain records appropriately
2c1 be able to monitor and review the ongoing effectiveness of planned activity and modify it accordingly
28. The Panel is satisfied that the failings on the part of the Registrant did not arise through a lack of competence. She had performed her duties as a Band 7 Biomedical Scientist for 9 years without previous capability action.
Decision on impairment
29. The Panel has to assess whether the fitness to practise of the Registrant is impaired as at today’s date. In doing so the Panel takes into account the HCPC Practice Note: “Finding that Fitness to Practise is Impaired”. The registrant has provided no information since her email of December 2014.
30. In considering impairment the Panel must consider both the “personal” component and the “public” component. The personal component includes the current competence and behaviour of the Registrant and the public component takes into account the need to protect service users, declare and uphold proper standards of behaviour and maintain public confidence in the profession.
31. The failings on the part of the Registrant occurred over a period of eight months. They related to many aspects of her role as a Band 7 Biomedical Scientist. There is no information from the Registrant which serves to show she has insight into her past failings. There is no material that demonstrates she has taken remedial action. Some aspects of the failings could have caused indirect harm to patients.
32. Taking into account all of those factors the Panel has concluded that the fitness to practise of the Registrant is currently impaired. To fail to make that finding would create a risk to service users, would not maintain professional standards and would not maintain public confidence in the regulatory process.
33. The Panel has taken into account the HCPC Indicative Sanctions Policy. It is not mandatory to impose a sanction. If a sanction is to be imposed it must relate only to the misconduct found or admitted. The primary function of a sanction is to address public safety issues although there will also be secondary considerations such as maintaining the reputation of the profession and public confidence in the regulatory process. Any sanction must be proportionate and a key factor to be considered is the extent of insight demonstrated by a registrant.
34. The aggravating features of the case are that:
(i) whilst no direct harm was caused to service users there was potential harm to patients and the potential waste of expensive and valuable blood products.
(ii) the misconduct continued over a period of eight months
(iii) the misconduct related to a number of the Registrant’s Band 7 duties
(iv) there is no evidence of reflection or remediation
(v) the Registrant has not engaged in this regulatory process since December 2014 and ,as such, the panel is unable to assess the Registrant’s level of insight and/or remorse
(vi) there is lack of acknowledgement on the part of the Registrant of her responsibility for the failings and their potential consequences
(vii) the Registrant operated as a competent Band 7 Biomedical Scientist for 9 years and must have been aware that she was breaching professional standards
(viii) the Registrant failed to draw the detail of the failings to Witness 1 despite opportunities to do so.
35. The mitigating features are:
(i) The Registrant’s previous unblemished career
(ii) evidence from Witness 1 that the Registrant acted in a positive and competent manner in her Biomedical Scientist “benchwork”
(iii) there is evidence that the Christie was experiencing organisational change and staff absences by reason of sickness.
(iv) there is some limited acknowledgement (in a workplace interview) from the Registrant as to some of her failings.
36. Bearing those factors in mind the Panel has considered the available sanctions in ascending order. The Panel has determined, given the findings above and the absence of insight and remediation that taking no action would fail to provide the proper level of public protection, fail to meet the public interest in declaring and upholding proper professional standards and fail to maintain confidence in the profession and the regulatory process. It is not appropriate against that background to consider mediation which is unlikely to be productive.
37. The Panel next considered a Caution Order and noted that the Indicative Sanctions Policy states that such an order may be an appropriate sanction for cases where the lapse is limited, there is a low risk of recurrence, the Registrant has shown insight and taken appropriate remedial action. None of those factors apply. In addition, a Caution Order would not provide a sufficient level of public protection. For those reasons a Caution Order is not appropriate.
38. Conditions of Practice will be most appropriate where a failure or deficiency is capable of being remedied and where the Panel is satisfied that allowing the registrant to remain in practice, albeit subject to conditions, poses no risk of harm or future harm.
39. The Panel has considered very carefully that the Registrant’s past failings may be remediable but also takes into account the lack of information from the Registrant as to her current circumstances. There has been limited engagement by the Registrant in this process. Given the absence of the Registrant it is not possible to make a reliable assessment as to her likely engagement with conditions or her willingness to address and remediate the past shortcomings. The Panel feels unable to draft conditions that would be workable and effective in providing the necessary level of public protection. It is therefore not appropriate to make a Conditions of Practice Order.
40. The Panel is satisfied in all the circumstances that a Suspension Order is the only effective, workable and proportionate order. The Panel has considered the appropriate period of suspension and has concluded it to be 6 months. In doing so the Panel has taken into account what is said on this point in the Indicative Sanctions Policy. This is a case where the Registrant has demonstrated a history of 9 years’ employment as a Band 7 Biomedical Scientist without previous professional misconduct or lack of competence. There are aspects of her competence that have been seen as positive by her line manager. Against that background the Panel is satisfied that if the Registrant were to make a positive future engagement with this regulatory process she may be able to provide a future panel with evidence that shows she is safe to practise again as a Biomedical Scientist even though there may be a need for some continuing restrictions on practice. On that basis the Panel is satisfied that the period of 6 months provides the correct and proportionate balance between:
(i) the need for adequate public protection, public confidence and
(ii) an opportunity for the Registrant to demonstrate on a future occasion that she has insight into past failings and has taken remedial action.
41. Given the prospect of future insight and remediation the Panel is satisfied that a Striking Off Order would be disproportionate and not appropriate.
42. The Suspension Order now being imposed will be reviewed by a Panel before it expires. The Registrant will be notified of the review hearing. The Panel encourages the Registrant to do all that she can to attend that review.
43. This Panel cannot bind the approach of any future Panel but it is likely to assist any review if the Registrant reflects on the above failings. It might assist a future Panel if the Registrant is ready to explain what action she has taken in the meantime to correct matters and to avoid repeating her shortcomings. Evidence of such action might be provided by:
i) training (to demonstrate she has kept up to date her Biomedical Scientist skills and knowledge),
ii) Paid or unpaid work testimonials in respect of any work undertaken since the Registrant left the Christie. This might include responsibilities for: staff training, record keeping, the proper management of equipment and stock levels.