Joan Coley

From Nadine Dorries MP 
Minister of State for Patient Safety, 
Suicide Prevention and Mental Health 

39 Victoria Street 
London 
SW1H 0EU 

Ms Louise Hunt 
HM Senior Coroner, Birmingham and Solihull 
HM Coroner's Court 
50 Newton Street 
Birmingham B4 6NE 

14 July 2021 

Dear Ms Hunt,  

Thank you for your letter of 31 March 2021 about the death of Joan Coley.  I am replying 
as Minister with responsibility for hospital care quality and patient safety and I am grateful 
for the additional time in which to do so.   

I would like to begin by saying how deeply sorry I was to read the circumstances of Ms 
Coley’s death.  That Ms Coley’s death was contributed to by failings in care is extremely 
distressing and I offer my most heartfelt sympathies to her family and loved ones.  We 
must do all we can to learn from such tragic incidents to ensure the safety of health 
services and prevent future deaths.   

In preparing this response, Departmental officials have made enquiries with Health 
Education England (HEE) and the UK Foundation Programme Office (UKFPO); The 
General Medical Council (GMC); as well as NHS England and NHS Improvement (NHSEI) 
and the Care Quality Commission (CQC). 

I am advised that 
Medical Director at HEE, and 
Education and Standards at the GMC, have provided detailed responses addressing the 
matters of concern in your report.  

, National Director of Education Quality and 

, Medical Director and Director of 

You will therefore be aware that UK medical schools determine the content of their own 
curricula and that the delivery of these undergraduate curricula are required to meet the 
standards set by the GMC, which monitors and checks to make sure that these standards 
are maintained.  The standards require the curriculum to be formed in a way that allows all 
medical students to meet the GMC’s Outcomes for Graduates by the time they complete 
their medical degree, which describe the knowledge, skills and behaviour they have to 
show as newly registered doctors. 

Page1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 The curricula for postgraduate specialty training are set by the Academy of Medical Royal 
Colleges for Foundation training, and by individual Royal Colleges and faculties for 
specialty training.  The GMC approves curricula and assessment systems for each training 
programme.  Curricula emphasise the skills and approaches that a doctor must develop in 
order to ensure accurate and timely diagnoses and treatment plans for their patients.  

The GMC has explained in its response that procedures using central lines are not 
included in the GMC’s Outcomes for Graduates as the GMC considers this to be beyond 
the level of competence required for newly qualified doctors.  However, medical students 
should be taught about the general risks associated with central lines.  

Similarly, the procedure of taking blood samples from central lines is not included in the 
Outcomes for provisionally registered doctors with a licence to practice that all Foundation 
Year 1 doctors should achieve.  It is the view of the GMC that the taking of blood samples 
from central lines is a procedure undertaken by specialists, or in specialist units and that: 

‘A doctor in training, and especially a recently graduated Foundation Year 1 doctor, 
should only undertake this procedure on the specific advice of, and under the direct 
supervision of, a suitably qualified senior colleague. They also must receive specific 
authorisation and training’.  

You may wish to note that the 2021 Foundation Curriculum, planned for introduction in 
August 2021, does not contain any specific procedural skills that must be acquired and 
assessed during the Foundation Programme.  Specialty focussed procedural skills must 
be learnt and performed while supervised before they are undertaken independently.  The 
importance of good supervision is emphasised throughout the Foundation Curriculum.  

Doctors in training are expected to acknowledge the limits of their capabilities and 
understand the risk of performing procedures beyond their level of competence.  

In addition, an employer should ensure that there is an appropriate process in place to 
approve a doctor’s competency to undertake specialist and high-risk procedures.  

In relation to determining the competency of a trainee doctor, the GMC response explains 
that its standards state that organisations:  

•  Must have a reliable way of identifying leaners at different stages of education 

and training and that learners are not expected to work beyond their 
competence; and,  

•  Make sure there are enough suitably qualified staff members to provide learners 

with appropriate clinical supervision at all times. In particular, Foundation 
doctors must have on-site access to a senior colleague who is suitably qualified 
to deal with problems that may arise.   

The GMC will continue to work to support local organisations in the West Midlands in their 
response to Ms Coley’s death to improve the quality and safety of the training 
environment.  The GMC has also indicated that it will share learning nationally.  

Page2 
 
 
 
 
 
 
 
 
 
 
 
 
 In addition, I welcome the actions that the UKFPO has confirmed it will take in response to 
the issues highlighted in your report, namely:  

•  Write to all UK Postgraduate Deans to request that they ensure their induction 

programmes for Foundation doctors are in protected time; include best practice; 
and, reinforce the requirements of Foundation Professional Capability 18: 
recognises and works within limits of personal competence; 

•  Cascade learning from your Prevention of Future Deaths report through the 

Postgraduate Deans/Foundation Schools, emphasising that: 

o  The taking of blood samples from central lines (and any other procedural 
skill not included in the GMC’s ‘Outcomes for Graduates’) must only be 
carried out independently by those who have been trained appropriately 
and confirmed to be competent to perform the procedure unsupervised; 
and,  

o  That all named clinical supervisors must have appropriate training and 
fully understand their responsibilities and accountability in undertaking 
this role. They must ensure an understanding of the competency levels of 
the trainees for which they are responsible and ensure appropriate 
supervision is provided at all times. 

I hope together these actions provide assurance that action is being taken to learn from 
the death of Ms Coley.    

Finally, you may wish to note that my officials have shared your report with the Healthcare 
Safety Investigation Branch (HSIB) to support its intelligence monitoring of patient safety 
risks.  The HSIB conducts national patient safety investigations where certain criteria are 
met.  In addition, your report has been brought to the attention of the Kidney Patient Safety 
Committee, a core structure of the UK Kidney Association which works closely with NHSEI 
and the Medicine and Healthcare products Regulatory Agency (MHRA), and I am advised 
that the Committee will consider the circumstances and concerns in your report that fall 
within its scope.  

I hope this response is helpful.  Thank you for bringing these concerns to my attention.  

NADINE DORRIES 

MINISTER OF STATE FOR PATIENT SAFETY, SUICIDE PREVENTION  
AND MENTAL HEALTH 

Page3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 26 May 2021 

Mrs Louise Hunt 
Senior Coroner for Birmingham and Solihull 
50 Newton Street 
Birmingham  
B4 6NE 

By email 

Dear Mrs Hunt  

Aston Medical School Response to the Regulation 28 Report to Prevent Future Deaths  

I am responding to your Regulation 28 Report dated 31.03.21 following the inquest and your 
ruling in respect of the death of the late Mrs Joan Coley.   

We have noted the six MATTERS OF CONCERN you raised namely: 

1.  Medical school training 

2. 

Induction programme for FY1 Doctors and assessment of base line competencies 

3.  How to effectively assess and monitor competencies to undertake procedures 

4.  Handover of competencies from ward to ward 

5.  General understanding of the process to follow when taking blood from a central line and the 

associated risks 

6.  Standard operating procedures for taking bloods from central lines 

As a medical school we have focused our attention on the first and fifth matter of concern and will 
liaise with Health Education West Midlands, the General Medical Council and Local Education 
Providers to keep informed of developments in the trainee curriculum.   

Following this serious incident senior members of teaching and administrative staff across the 
MBChB programme at Aston Medical School (AMS) have met to review the School’s relevant 
curriculum and documents, to discuss the practical procedures programme with Sandwell and West 
Birmingham Hospitals and to discuss your Regulation 28 Report and recommendations.  We also 
met with the medical student involved and read the student’s statement to identify gaps in 
knowledge and understanding and potential weaknesses in our processes. 

Page4 
 
 
 
 
 
              
 
 
 
 
 
 
 
 
 
 Re  
1. Medical School Training and  
5. General understanding of the process to follow when taking blood from a central line and the 
associated risks 

The GMC regulates undergraduate medical education and defines the Outcomes for Graduates 
(GMC, 2018) and the required Practical Skills and Procedures (GMC, 2019).  The latter is available at 
https://www.gmc-uk.org/-/media/documents/practical-skills-and-procedures-a4_pdf-
78058950.pdf 

Managing and caring for central venous lines is not included in this list for graduating medical 
schools; Aston Medical School will therefore focus its efforts, from Year 1, on ensuring students 
have a good understanding of the clinical significance of the physiology of the large central veins 
and how these differ from peripheral veins.  In Year 3, students will be introduced to the risks 
associated with central lines, supported by case-based learning and throughout Years 3-5 students 
will be reminded of the causes of air embolism and its emergency treatment.   

We will develop or source a standard infogram or picture to succinctly, dramatically and repeatedly 
inform students that a central line must never have both the clamp and cap open at the same time.  

As Year 3 students begin the long clinical placements we shall emphasise the Practical Procedures 3 
Question Rule (described in the Action Plan) that students must use to decide if they can undertake 
procedures on patients, and students will be required to seek agreement from a Specialty Trainee 
or Consultant if they wish to undertake a procedure not explicitly listed in the curriculum.     

The lessons learned from this serious incident must be transferred to other procedures; there is 
potential for error and harm with respect to other procedures not currently on the GMC list.  We 
will therefore include teaching on generic and specific risks of practical procedures throughout 
Years 3-5, through videos, lectures, handbooks and discussions of scenarios including serious 
incidents.  We will ensure students understand the risks of procedures within the curriculum and 
are introduced to the risks of the most common procedures which they may observe but which are 
outwith the undergraduate curriculum.   

As a result of our internal review of materials we have also refined titles and descriptions to 
highlight the difference between peripheral and central vein procedures.   

To maximise the learning and impact of our action plan we will meet with Sandwell and West 
Birmingham Hospitals (SWBH) within the month to discuss our reports and implications for 
teaching and practice across the medical school and the Trust.  Going forward, we will inform all 
our Local Education Providers of our developments within Practical Procedures through our 
meetings, handbooks and training sessions.   

Page5 
 
 
 
 
 
 
 We will share our response to your Regulation 28 Report with the Regional Postgraduate Dean 
West Midlands and meet with his team.  Finally the GMC is planning to meet with the University of 
Birmingham and Aston Medical School together, in the near future, to review the implications of 
your report and our responses for other medical schools.   

Please find attached a more detailed Action Plan in response to your recommendations.  It also 
draws on the AMS internal review of curriculum and documents, review and discussion of the AMS 
student’s statement, and correspondence and discussion with SWBH regarding practical 
procedures.   

Yours sincerely 

Interim Head of School 
Dean of Medical Education 

Cc: GMC; Regional Postgraduate Dean HE West Midlands 

Page6 
 
 
 
 Ms L Hunt
Senior Coroner for Birmingham and Solihull

Dear Madam,

Re: University of Birmingham Coroner Response

Institute of Clinical Sciences
College of Medical and Dental Sciences 
Edgbaston Birmingham B15 2TT
United Kingdom

4th June 2021

We were saddened to hear of the death of Joan Mavis Coley from sepsis contributed to by an air 
embolus caused by inadvertently leaving a central line unclamped.

At the University of Birmingham Medical School we take the requirement to ensure that upon 
graduation, all our medical students are able to practice in a safe and competent manner and are 
able to meet all the requirements determined by the General Medical Council in its document 
‘Outcomes for Graduates’ and supplementary document ‘Practical Skills and Procedures.’ This 
document in particular, outlines the core set of practical skills and procedures, and minimum level of 
performance that newly qualified doctors must have when they start work for the first time, so they 
can practice safely. For each core skill or procedure, the GMC has determined three levels of 
competence: 

1. Safe to practice in simulation 
2. Safe to practice under direct supervision 
3. Safe to practice under indirect supervision 

It is noticeable that this document does not make mention of the need to know or show how to take 
blood from a central line, the physiology involved or the potential risks. 

Nevertheless, it has been a local requirement for several years for medical students at the University 
of Birmingham Medical School to demonstrate competence in undertaking blood sampling from a 
central line under direct supervision.

Only students in their final year of study are permitted to undertake this procedure and they are not 
able to do so unless they have first undertaken a simulated training session and participated in the 
pre-course learning. Medical students who are not in their final year are not permitted or required 
to undertake practice in this skill. 

Pre-course learning

Consists of a ‘storyboard’ of how to take blood from a central line, and a twenty-slide power point 
presentation with the following learning outcomes:

Page13 Recognition and indication of CVAD use


 Understand potential complications and their management (including, notably, air embolism 

from an uncapped central line port or on line insertion)

 Monitor and manage ongoing care

Identify relevant documentation
 Understand principles of removal

Taking and management of bloods

Simulated training session

The content of the simulated training session is reviewed yearly and delivered by a specialist clinical 
skills team who are part of the Queen Elizabeth Hospital Birmingham.  Attendance is mandatory and 
attendance records are kept. The procedure is demonstrated by the clinical skills team, with an 
opportunity to undertake the procedure in the clinical skills simulation laboratory.  Only when this 
has been achieved are students permitted to undertake the procedure of accessing a central venous 
access device in clinical practice, and then only under direct supervision.

Up until July 2021 it has been a requirement of the University of Birmingham Medical School that 
final year medical students undertake three successful attempts of accessing a central venous access 
device under direct supervision.  Successful attempts are deemed to occur when the clinician 
supervising the medical student feels that they have adequately followed the correct procedure in a 
safe manner.  

Audit of student procedure practice of accessing a central venous access device

Each student is required to keep an electronic record of their attendance at the clinical skills 
simulation day and confirm that they have safely and competently demonstrated accessing the 
device in simulation, signed by a clinical skills trainer. Each time a student undertakes the procedure 
in clinical practice under direct supervision they will record this in their student clinical skills 
electronic record, which will be countersigned and dated by the supervising clinician.  The University 
of Birmingham Medical School has determined that only clinicians or healthcare professionals who 
are familiar and deemed competent with this procedure in normal clinical practice should supervise 
a final year student in undertaking this skill.  It has been our expectation that this would usually be 
restricted to those clinicians/health care professionals working in intensive care or anaesthesia. All 
final year students are required to record that they have successfully accessed a central venous 
device on a minimum of three occasions in clinical practice, under direct supervision. This forms part 
of the requirement for all final year students to graduate and progress into the foundation training 
programme and is reviewed by the exam board.

Alterations to training further to the Regulation 28 report to prevent future deaths

It is the intention of the University of Birmingham Medical School to continue to mandate 
participation of the pre-course learning content and simulated training session all final year students 
undertake in accessing central venous devices. Emphasis will continue to be placed on recognition 
and preventing and managing complications. However, it has become increasingly more difficult for 
students to achieve the previously required number of attempts of procedural practice in this skill as 
a result of COVID-19. Furthermore, it has been recognised that outside of the critical care 
environment there are few clinicians who are able to demonstrate the required familiarity with the 
procedure in order for them to clinically supervise students undertaking this skill.  For this reason, 
whilst we will encourage students to undertake the clinical skills of accessing a central venous device 
under appropriate direct clinical supervision, where the opportunity arises, it will no longer be a 

Page14 requirement for students to demonstrate a minimum number of successful attempts in order to 
graduate.

We trust that this information will help with your enquiry and please do not hesitate to contact us 
further if we can be of any further assistance.

Yours sincerely

Senior Clinical Lecturer University of Birmingham 
Clinical Skills Lead MB ChB Programme

MB ChB Programme Lead
Vice Dean Birmingham Medical School

Dean Birmingham Medical School

Page15  
 Trust Headquarters  
Sandwell Hospital 
Lyndon 
West Bromwich 
B71 4HJ 

Mrs Louise Hunt 
Senior Coroner for Birmingham and Solihull 
50 Newton Street  
Birmingham  
B4 6NE 

11 May 2021 

Dear Mrs Hunt 

Response to the Regulation 28 Report to Prevent Future Deaths  – the late Joan Coley 

I am in receipt of your Regulation 28 Report following the inquest and your ruling on 30 March 2021, 
in respect of the late Mrs Joan Coley. This letter will be copied to Mrs Coley’s family and I would 
extend, through you, my condolences once again for their loss. 

Recognising that a number of the recommendations focus on training of doctors and the networks 
which support this, there are steps we can take to further support medical staff joining and rotating 
within the Trust and protect our patients. These steps are a collective view following discussion with 
the Medical Education Director, Undergraduate and Postgraduate tutors. Conversations have also 
been had with leaders from HEWM to whom a copy of this report will be sent for consideration of 
the factors that we will be putting in place and how this might link with any wider learning or advice 
for trainee supervision at other organisation. 

1.  Medical school training 

Whilst not a Medical School, Sandwell & West Birmingham Hospitals NHS Trust (“the Trust”) is 
affiliated with two Medical Schools at Birmingham University and Aston University and, as such, 
provide opportunity for Medical Students and Doctors to develop their skills on patients safely. 
The GMC have produced guidelines regarding the level of competence expected of newly 
qualified doctors (Appendix 1, pages 3-5). Central venous catheter lines are not included in this 
list as it is an aspect of training considered appropriate and delivered at Core Medical Training 
(CMT)  level (more than 2 years after qualifying)(Appendix 2, page 22). At CMT level, theoretical 
training, skills lab and supervised training is provided over a 3 year period. Competence is 
documented in the trainee’s e-portfolio by their designated clinical supervisor. Prior to this stage 
of training, junior doctors and medical students are not expected to interact with central venous 
catheter lines due to their inherent complexity and risks. These are national guidelines produced 
by the Joint Royal College of Physicians Training Board.  

Page19 
 
 
 
 
 
 
 At the Trust, this guidance will be re-enforced to trainees, with the only exception to this being 
for those doctors in training undertaking specialist training on the intensive care unit. In this 
specialised setting, theoretical and practical training will be given during Foundation Years posts 
and competence confirmed by the trainees clinical supervisor in the trainee’s e-portfolio.  

In light of the Coroner’s Inquest findings, as part of their induction to the Trust, procedural risks 
related to central venous catheter lines will be introduced to the 3rd year medical student 
themed week case based discussions, to 3rd, 4th and 5th years and Foundation Year Doctors.  

Foundation Year doctors will be trained in the theoretical use of central lines but will not be 
allowed to undertake blood sampling, flushing, insertion nor removal of central venous catheter 
lines. During meetings between doctors in training and their educational supervisor, working 
safely within their competence level will be emphasised. Progress with the acquisition of 
competence in procedural skills appropriate to that level of training, will be assessed at each 
meeting. All doctors and medical students will be advised to avoid any clinical practical 
procedures that are not specifically documented in their clinical skills portfolio appropriate for 
their level of training.  

2. 

Induction programme for FY1 Doctors and assessment of baseline competencies 
Foundation year doctors will not be allowed to take blood from central venous catheters at this 
Trust.  

This will be the remit of fully trained and competent nursing staff, outreach ITU nurse/medical 
team or a medical registrar (a doctor more than 4 years since qualifying). 

Theoretical training will be provided to the foundation year doctors in preparation for later stages 
of their training, including a simulation based session on a cardiac arrest resulting from an air 
embolism during central vein catheter blood sampling. CMT level will receive theoretical training, 
skills lab and supervised training over a 3 year period. Competence is documented in the trainee’s 
e-portfolio by their designated clinical supervisor. This is in line with national guidelines produced 
by the Joint Royal College of Physicians Training Board. 

3.  How to effectively assess and monitor competencies to undertake procedures 

We will liaise with HEE to determine the optimal strategy for assigning competence to a range of 
clinical skills and a requirement that trainees do not undertake clinical procedures without 
supervision until they have been signed off as being competent, as long as these skills are 
included within their e-portfolio requirements for their level of training.  

Any clinical skills not considered appropriate for their stage of training must be avoided. The use 
of central lines is part of the CMT curriculum and is formally assessed during their training after 
theoretical, simulated and supervised practice. 

The Trust will look at identifying a list of discussion points around the previous week, focusing on 
procedure risks, event information, learning from others and safety advice during the weekly 
meetings held between Clinical Supervisors and Foundation Year Doctors. 

2 

Page20 
 
 
 
 
 
 
 
 
 4.  Handover of competencies from ward to ward 

A summary of clinical skills competence will be forwarded to clinical supervisors on each rotation 
of junior doctors (by the junior doctor following an exit review by their current clinical supervisor) 
to ensure there is an awareness of skills competence and areas of lack of training.  

There will be a requirement for all supervising consultants to check documented competency 
when assigning tasks in the clinical environment. No doctor will be allowed to undertake any 
procedure unsupervised, at any level of training, unless they have been signed off as being 
competent in that clinical skill/procedure. 

5.  General understanding of the process to follow when taking blood from a central line and the 

associated risks 
Additional training and education will be introduced into our undergraduate and postgraduate 
teaching portfolio, including Trust induction, to highlight safety issues related to central venous 
catheters. An email has been sent to all doctors at the Trust clearly stating the precautions 
required when dealing with a central venous catheter including the risk of air embolism.  

Documents exist on the Trust’s intranet describing the correct use of central venous catheters, 
the risks of air embolism and how to avoid this. Additional theoretical training will be introduced 
to medical students and Foundation year doctors as to the risks related to using central venous 
catheters. 

6.  Standard operating procedures for taking bloods from central lines 

Documents exist on the Trust’s intranet clearly describing the correct use of central venous 
catheters with particular note to the risk of air embolism and how to avoid this complication.  

All staff have been sign posted to the pre-existing guidance which has been re-enforced. A new 
guideline will be written with the benefit of the inquest findings to include additional pictorial 
emphasis to avoiding uncapping and unclamping at the same time. 

Health Education England will liaise with the GMC to qualify the following GMC statement, ‘It is 
important to remember that newly qualified doctors who enter the Foundation Programme will 
work under educational and clinical supervision and in a multidisciplinary team. In accordance 
with the Foundation Programme Curriculum, they will need to demonstrate that they are refining 
their skills and that they are able to take responsibility appropriately whilst recognising and 
working within the limits of their competence.’(Appendix 1, page 3) 

This should ideally state, ‘All practical procedures not documented as appropriate for that stage 
of training, in the trainees portfolio should be avoided unless fully supervised by a fully 
competent trainer who has made the assessment that the trainees involvement in the procedure 
is appropriate and safe. Trainees should not be involved in any practical procedure unsupervised 
until they have been designated as being fully competent in that procedure by their clinical 
supervisor.’ 

3 

Page21 
 
 
 
 
 The Patient Safety page on the intranet will evidence a ‘Learning Alert’, a pictorial reminder of 
the safe way of sampling from central lines, with intermittent communications on the correct 
processes being ‘pushed’ to doctors and nursing staff (where appropriate) 

As well as addressing the specific points raised, following the Inquest hearing, we consider that there 
is wider learning with regard to other procedures. The risks of undertaking similar procedures or 
around certain incidents will be highlighted through a series of short films, recorded power points, 
pushed out to the doctors and loaded onto our Intranet page for quick referral. 

In reviewing this procedure, and the way the system let down both our junior doctor and Mrs Coley, 
the appropriateness of delegation was considered and reiterated to Consultants. This will be further 
emphasised across the Trust to all disciplines. 

I attach the implementation plan for those actions which resulted from the serious incident 
investigation and your ruling. 

 Yours sincerely 

Interim Chief Executive 

Cc  

Family of Mrs Joan Coley 
NHS England 
CQC 
Regional Medical Examiner,  
Birmingham and Solihull CCG  
Black Country and West Birmingham CCGs 
Health Education West Midlands 

4 

Page22 
 
 
 
 
 
 
 25 May 2021 

Louise Hunt 
HM Senior Coroner for Birmingham and Solihull 

Dear Mrs Hunt 

Regulation 28: Report to Prevent Future Deaths 

I was really sorry to hear of the tragic circumstances that led to the death of Joan 
Mavis Coley. I extend my sincere condolences to Joan’s family and all others 
affected.  

You raise six concerns in your report. Before I turn to those, let me summarise the 
role of the GMC as a regulator and how it relates to the education and training of 
medical students and doctors. Then I will explain our involvement in the case prior 
to your letter, and finally I will respond to the important questions and 
recommendations you raise. 

Our role as a medical regulator 

Our powers in medical education, as set out in the Medical Act 1983, are two-fold: 
to set the outcomes for graduates of UK medical schools leading to entry on to the 
medical register and to approve the curricula for postgraduate training of doctors. 
We quality assure both aspects of medical training against our standards for the 
management and delivery of medical education and training. The principle of 
patient safety drives our work. 

Undergraduate education 

Our powers don’t extend to mandating specific content in undergraduate curricula, 
but we determine and publish the high-level outcomes all medical students are 
required to demonstrate in order to graduate and be awarded a Primary Medical 
Qualification (PMQ). We updated our Outcomes for graduates in 2018 after 
extensive consultation. This is supplemented by a set of core Practical skills and 
procedures graduates must have achieved when they start work for the first time 
so they can practise safely.  

Page73  
  
 
 
 Foundation Programme 

All doctors enter the two-year Foundation Programme after graduating from a UK 
medical school. It provides new graduates with a range of essential interpersonal 
and clinical skills for managing acute and long-term conditions. The Academy of 
Medical Royal Colleges develops the Foundation Programme curriculum, which 
describes specific outcomes all Foundation doctors should demonstrate on 
completion of the programme. Our regulatory role is to approve the curriculum.  

The Foundation Programme curriculum requires first year trainees (FY1) to meet 
the outcomes we have set out in Outcomes for provisionally registered doctors with 
a license to practise, which includes fifteen core clinical and procedural skills. This 
enables the trainee to apply to the GMC for full registration and a license to 
practise, which is a requirement of entry to the second year of the Foundation 
Programme.  

Quality assurance of education and training 

We also have a duty to make sure medical education and training in the UK is 
meeting our standards. We expect organisations responsible for educating and 
training medical students and doctors in the UK to meet the standards set out in 
Promoting excellence: standards for medical education and training.   

We quality assure medical schools, postgraduate deaneries and local offices, and 
local education providers (such as NHS trusts and health boards) to check they are 
meeting our standards. Our quality activities are risk based, which means we look 
at our evidence and decide which areas are likely to be of concern. We provide 
feedback to organisations on how well we think they are meeting our standards. 

If we are concerned about something, we ask for more information to seek 
assurance that any issues are being dealt with appropriately, and if we're not 
satisfied with the response we can intervene.  

We can place organisations providing postgraduate training under ‘enhanced 
monitoring’, which we do to promote and encourage local management of concerns 
about quality and safety. This involves more frequent progress updates and we can 
provide representation on a locally led visit to investigate a concern or check on 
progress. Where possible we work with all organisations to address the concern 
and develop a sustainable solution. Sometimes we need to work with other 
regulators to make improvements.  

We also approve new medical schools, which we subject to an extensive period of 
quality assurance to ensure their programmes will deliver the Outcomes for 
graduates and meet the Promoting Excellence standards.    

2 

Page74 
 Our response to this incident 

Since being notified of the incident by Aston Medical School in December 2020, we 
have been engaging with local organisations regarding the immediate and long-
term measures that will be taken to protect patients and to support those involved.  

Our West Midlands Employer Liaison Adviser has met with Sandwell and West 
Birmingham NHS Trust to discuss the incident and their response. He has also held 
discussions with Health Education England West Midlands (HEE WM). We will work 
with both organisations to monitor the situation and ensure appropriate measures 
are being implemented.   

Aston Medical School is subject to the enhanced quality assurance measures we 
apply to all new medical schools, we will continue to liaise with Aston about this 
incident and their response to your report will feed into this quality assurance 
activity.  

We will organise a meeting with local organisations to ensure that the issues 
identified in your report are being satisfactorily addressed. We will also share our 
response to your report with local and national organisations to reinforce the 
learnings from this incident to prevent a similar incident happening again locally or 
nationally.  

Addressing your specific concerns and recommendations 

Against the general background of our regulatory powers and the specific actions 
taken already, I will now address each of the recommendations in your report.  

In doing so I will refer to our standards, which state that learners’ responsibilities 
for patient care must be appropriate for their stage of education and training. 
Supervisors must determine a learner’s level of competence, confidence and 
experience and provide an appropriately graded level of clinical supervision.  

Medical school and Foundation Year 1 training  

You recommend urgent action is taken to review the training provided to medical 
students. The inquest heard there is limited training on taking bloods from a 
central line, the physiology of the procedure and its potential risks, and that the 
FY1 doctor felt she did not have adequate understanding of the risks of performing 
this procedure. 

Procedures using central lines are not included in our Outcomes for graduates as 
we consider it to be beyond the level of competence required for newly qualified 
doctors. However, medical students should be taught about the general risks 
associated with central lines. It would be unsafe for them to access these lines 
given their complexity and the high level of risk involved.  

3 

Page75 
 You have advised that we should also consider including the procedure on the 
checklist of tasks for junior doctors. The inquest heard that the procedure is not on 
the checklist, which meant there was no process in place to determine individual 
competency.  

Taking bloods from central lines is not included in our Outcomes for provisionally 
registered doctors that all FY1 doctors must achieve. It is a procedure undertaken 
by specialists or in specialist units, and it would be inappropriate for this to be a 
requirement for all Foundation Programme doctors. A doctor in training, and 
especially a recently graduated FY1 doctor, should only undertake this procedure 
on the specific advice of, and under the direct supervision of, a suitably qualified 
senior colleague. They also must receive specific authorisation and training. 

Doctors in training are expected to acknowledge the limits of their capabilities and 
understand the risk of performing procedures beyond their level of competence. 
However, there must be effective systems, policies, and processes for determining 
their competency to undertake procedures, whether they have received 
appropriate training, and the level of supervision needed to ensure patient safety.    

Systems for determining trainee competency 

In the absence of a formal system for assessing a doctor’s competence to 
undertake a particular procedure, a doctor’s agreement to perform a task was 
taken as an indication of their competency. This put the onus on to the doctor to 
decline tasks beyond their competency or ensure an appropriate level of clinical 
supervision was provided.  

The more senior doctor in training and FY1 doctor both lacked an appropriate level 
of understanding of the procedure and the competency to perform it unsupervised, 
although neither realised this when the task was delegated. The doctor in training 
determined that the FY1 doctor was competent and could, with the assistance of 
the medical student, undertake it safely. An appropriate employer process should 
be in place to approve a doctor’s competency to undertake specialist and high-risk 
procedures.  

Your report notes the absence of a system to share information about trainee 
competency between wards. The FY1 doctor was shadowing the ward and the 
consultant had no understanding of the FY1 doctor’s competencies, as no such 
system was in place.  

Our standards state that organisations must have a reliable way of identifying 
learners at different stages of education and training. They must also make sure all 
staff members take account of this, so that learners are not expected to work 
beyond their competence.  

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 Our standards also require organisations to make sure that there are enough 
suitably qualified staff members to provide learners with appropriate clinical 
supervision, at all times. Supervisors must determine a learner’s level of 
competence, confidence and experience and provide an appropriately graded level 
of clinical supervision. Foundation doctors must have on-site access to a senior 
colleague who is suitably qualified to deal with problems that may arise during the 
shift.  

We will continue to work with employers, HEE WM and the medical schools to 
monitor the actions being taken, and to ensure sustainable changes are made that 
will improve the quality and safety of the training environment.  

Awareness of all doctors and proposal for a standard operating procedure  

Your report recommends that consideration is given to ensuring all doctors are fully 
aware of the basic principles and risks when taking bloods from a central line. This 
includes the development of a national standard operating procedure that could be 
linked to training and assessment of competency. As any such measures would be 
aimed at all doctors employed across the UK’s health services, rather than those 
currently within GMC-regulated training programmes, national service and 
education providers such as HEE and NHS England would be best-placed to 
comment on such proposals.  

Specialist associations or representative bodies may also be able to assist with 
these recommendations. As an example of where these bodies have responded to 
earlier incidents, the removal of dialysis lines was reported to the National Patient 
Safety Agency in 2018 and the Renal Association, British Renal Society, and 
Intensive Care Society set out advice and an action plan in response. This 
recommended a number of precautions and monitoring measures and indicated 
national guidelines would be developed.  

Final reflections 

We welcome the publication of this Report to Prevent Future Deaths as an 
important measure to raise awareness of the incident with those who can take 
action to prevent future deaths. We have carefully considered your concerns. I 
hope this information provides reassurance of the actions we have been taking and 
will take with local and national organisations to ensure a similar incident does not 
happen again.  

Yours sincerely 

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 Medical Director and Director of Education and Standards 

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 11 June 2021 

Louise Hunt  
HM Senior Coroner for Birmingham and Solihull 

Dear Mrs Hunt 

Regulation 28: Report to Prevent Future Deaths – Joan Mavis Coley 

Further to my letter of the 25th May 2021 regarding the tragic circumstances that 
led to the death of Joan Mavis Coley, we have spoken to Birmingham Medical 
School regarding their response to you of the 4th June. They had stated: 

“it has been a local requirement for several years for medical students at the 
University of Birmingham Medical School to demonstrate competence in 
undertaking blood sampling from a central line under direct supervision.”  

I wanted to make you aware that they have agreed that this will now cease, but I 
will write to you again shortly with a more detailed response indicating further 
actions we will take.   

Yours sincerely 

Medical Director and Director of Education and Standards 

Copied to: 
medicine degree programme 

, Vice Dean for Medicine and programme director for the 

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