Karen Starling and Anne Martinez

• 

Department 
of Health & 
Social Care 

HM  Assistant Coroner 
Keith Morton KC 
Area of Cambridgeshire and  Peterborough 
Lawrence Court 
Prin~ess Street 
Huntington 
PE29 3PA 

Dear Mr Morton, 

F:rom  Lord Markham 
Parliamentary Under-Becretary of State 

39 Victoria  Street
London
SW1H0EU 

24 July 2023 

Thank you for your letter of 14 November 2022,  to the Secretary of State for Health and Social Care 
Steve  Barclay,  about the death  of Karen  Starling  and  Anne  Martinez  I am  replying  as  Minister with 
responsibility for the NHS capital,  land and  estates. 

Firstly,  I would like to say how saddened  I was to  read  of the circumstances of Mrs Starling and  Ms 
Martinez's  death  and  I  offer  my  sincere  condolences  to  their  family  and  loved  ones.  The 
circumstances your report describes are very concerning  and I am  grateful to you for bringing these 
matters to my attention. 

As you set out in your report,  the guidance available to those responsible for the design, construction 
and  operation  of hospitals,  including  hospital  water  systems  is  Health  Technical  Memorandum  04-
011. 

Health  Technical  Memorandums  are  owned  by  NHS  England  (NHSE)  and  they  are  the  correct 
organisation  to  respond to the concerns you raised  in  your report. 

I note that NHSE wrote to you on 6 February 2023, setting out their response to each of your concerns. 
The Department of Health and Social Care does not have additional detail or information to add further 
to NHSE's letter. 

Thank you for bringing these concerns to  my attention. 

LORD MARKHAM CBE 

1  https://www,england.nhs.uk/publication/safe-water-in-healthcare-premises-htm-04-01/

HM Assistant Coroner, Keith Morton KC  
Area of Cambridgeshire and Peterborough  
Lawrence Court 
Princess Street  
Huntington 
PE29 3PA 

National Medical Director  
NHS England  
Wellington House 
133-155 Waterloo Road  
London 
SE1 8UG 

06 February 2023  

Dear Mr Morton, 

RE: Inquests into the deaths of Karen Lesley Starling and Anne Edith Martinez: 
Report to Prevent Future Deaths (PFD) 

I am writing on behalf of NHS England in response to the PFD sent to the Secretary 
of State for Health and Social Care dated 14th November 2022. Health Technical 
Memorandum 04-01, Safe Water in Healthcare Premises (HTM 04-10), the subject 
of the PFD, was published by the Department of Health and Social Care (DHSC) in 
2016, but responsibility for this guidance transferred from the DHSC to NHS England 
in 2017.  

My colleagues in NHS England’s National Estates Team and regional East of 
England Team have contributed to this response to assist in outlining the wider 
support that has been provided to the Royal Papworth Hospital NHS Foundation 
Trust (the Trust). 

NHS England was not involved in these inquests, but we would like to extend our 
condolences to Ms Starling and Ms Martinez’s families for their losses.  
NHS England is grateful to HM Coroner for identifying your concerns in respect to 
Health Technical Memorandum 04-01, Safe Water in Healthcare Premises (HTM 04-
01). I have endeavoured to respond to your concerns below, which I understand 
from the PFD are as follows:  

1.  It  is  recognised  that  M  abscessus  poses  a  risk  of  death  to  those  who  are 
immunosuppressed.  That  will  be  so  for  many  patients  at  specialist  hospitals 
such as Royal Papworth and more generally for hospital patients. To date, 34 
patients at Royal Papworth have contracted M abscessus from the hospital’s 
water. Cases continue to be reported, albeit at a declining rate;   

2.  There is an incomplete understanding of how M abscessus may enter and/or 

colonise a hospital water system;    

3.  Health Technical Memorandum 04-01 Safe Water in Healthcare Premises was 
published by the Department of Health in 2016. It is concerned with the design, 
installation,  commissioning  and  operation  of  hospital  water  systems.  This 

                                                                                                                       
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
   
 guidance  requires  urgent  review  and  amendment,  whether  by  way  of  an 
Addendum or otherwise because:   

a.  It  is  a  key  document  for  hospital  estate  managers  and  Water  Safety 

Groups;   

b.  It purports to provide comprehensive guidance on waterborne bacteria;   
c.  However,  it  provides  no  relevant  guidance  in  relation  to  mycobacteria 
and  none  in  relation  to  M  abscessus.  It  provides  no  guidance  on  the 
identification  and  control  of  M  abscessus.  It  does  not  require  routine 
testing for mycobacteria, including M abscessus or provide guidance on 
acceptable  levels  (if  any).  Compliance  with  the  guidance  does  not 
identify or guard against the risk from M abscessus;    

d.  It provides no guidance on any additional measures that may be required 
in  respect  of  “augmented  care”  patients,  including  those  who  are 
immunosuppressed;   

e.  It is not in any event consistent with British Standard BS 8580-2:2022 on 

Water Safety.   

4.  There is evidence that the risk from M abscessus is especially acute for new 
hospitals.  Consideration  needs  to  be  given  to  whether  special  or  additional 
measures are required in respect of the design, installation, commissioning and 
operation of hospital water system in new hospitals.   

Support provided to the Trust  

Oversight and governance 

Following notification by the Trust regarding the initial patients’ testing positive for 
Mycobacteroides abscessus (M. abscessus), from 25th November 2020 incident 
management meetings were established between the Trust and NHS England with 
representation from Infection, Prevention and Control, Leadership and Quality and 
Commissioners. The purpose of these meetings was to: 

•  Understand the incident and the effect on patients; 
•  Be assured of the actions being undertaken by the Trust to mitigate risk to 

patients; 

•  Be assured of the communication and duty of candour actions regarding 
current and future events and informed patient and carer decisions; 
•  Be assured that all necessary expert input had been sought and actions 

implemented, and 

•  Offer support and advice.    

In addition to the above meetings, NHS England’s Leadership and Quality Team 
hold quarterly Clinical Quality Review Group (CQRG) meetings. This meeting is 
chaired by the Director of Nursing, Leadership & Quality for NHS England (East of 
England), and includes senior members from the Trust and NHS England, along with 
representatives from Cambridge & Peterborough Integrated Care Board. 

For the initial period of the M. abscessus incident the CQRG meeting paid particular 
attention to M. abscessus. Assurance regarding patient communication and Duty of 

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 Candour was a significant component of the assurance required at the CQRG 
meetings by NHS England. 

Assurance on patient experience 

NHS England reviewed that the Trust’s website has clear explanations about the M. 
abscessus incident on its website and the risk of M. abscessus is routinely discussed 
as part of the pre-operation / consent process and decision making. NHS England 
has been informed that, as of 22 November 2022, no patients have opted not to 
continue with surgery. 
Assurance was also required and given from the Trust regarding the mitigation and 
on-going surveillance that was implemented to protect vulnerable patients and to 
support them in the pre-operative decision making that was required by the patient.  
NHS England has been given assurance that risk assessments are undertaken for 
all patients on admission. Patients who are immunocompromised or at a higher risk 
are provided with bottled water and additional Infection Prevention measures are 
implemented. All patient rooms are single rooms with ensuite facilities, and all taps 
and showers are fitted with additional filters which are changed regularly and in 
between patients.  

Stakeholder Collaboration 

In addition to the quarterly CQRG meetings, a specific monthly meeting was 
established between NHS England’s Leadership and Quality Team, chaired by the 
Director of Nursing, Leadership & Quality for NHS England (East of England), and 
colleagues from the United Kingdom Health Security Authority (UKHSA). The 
purpose of these meetings was for UKHSA to provide assurance to NHS England of 
the governance, the progress and completion of agreed actions from the incident 
management meetings, and to ensure that optimum support and collaboration was 
provided to the Trust in the management of the incident.  

Meeting frequency reduced from July 2022 once support and collaboration were 
evident, but the frequency will be increased if there are any concerns, which are 
regularly monitored. Actions following the meeting are outlined below.  Increased 
support for the Trust from UKHSA colleagues at UKHSA’s Porton Down site has 
been confirmed with offers to: 

•  Develop a sampling rationale/strategy and take samples from water sources 

and outlets in Royal Papworth Hospital; 

•  UKHSA now attends the operational meetings internally at the Trust; 
•  Carry out air sampling using active and passive air sampling; 
•  Using nontuberculous mycobacteria (NTM) isolates recovered from the 

hospital environment to assess efficacy of disinfectants and compare their 
susceptibility to isolates from elsewhere. The purpose of this is to ascertain if 
there is evidence to suggest that Royal Papworth Hospital isolates have 
increased tolerance; and  

•  Assess the impact of water chemistry, to establish if there is evidence to 

suggest that the incoming water may facilitate persistence.  

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 NHS England’s East of England Infection Prevention and Control lead has been 
supporting and facilitating the collaborative working between the Trust and UKHSA. 
This led to further specialist input from UKHSA National mycobacterium reference 
lab, field services, and the environmental microbiologist at the Porton Down 
laboratory, to support the Trust with water and environmental sampling. 

The Trust’s Estates Team are actively engaged with NHS England’s Estates Team 
and several visits from the regional team have taken place, including conversations 
regarding the pipe work and recommendations for enhanced cleaning. These actions 
are included and monitored through a Trust Executive Oversight Committee which 
was established in July 2022, of which NHS England and UKHSA are core 
members. This Committee meets quarterly and is chaired by the Director of Nursing 
at the Trust. NHS England attendance at this meeting continues (with attendance 
from the Director of Nursing, Leadership & Quality, Head of Nursing and Medical 
Director for NHS England (East of England)), and the M. abscessus incident remains 
a standing agenda item as it does at the CQRG meetings. 

It is noted that as part of the collaborative working with external stakeholders, the 
Trust reviewed its internal governance structure which led to a new M. abscessus 
governance structure. This allowed for NHS England and UKHSA to be part of the 
discussions via the Trust’s Executive Oversight Committee which directly feeds into 
the Trust’s Quality and Risk Committee and in turn the Trust’s Board of Directors. 

The Trust’s Executive Oversight Committee is multi professional and multi 
organisational and provides a system of oversight of the recommendations and 
action plans associated with the M. abscessus incident. It brings together the 
updates and actions from the groups within the Trust’s M. abscessus governance 
structure and provides oversight and assurance of the actions and their progress 
whilst offering a forum for discussion and clarification.  

Principal Engineer site visit 

NHS England’s National Principal Engineer undertook a site visit of Royal Papworth 
Hospital on 23rd February 2022 in conjunction with the Trust’s Director of Estates 
and Facilities, to look at the physical environment and the water system.  
A large, complex water system has been installed at the hospital which has required 
40 flushing valves to subsequently be installed. It was understood that a number of 
different disinfectants had been tried on the system and was having a deleterious 
effect on the pipework and fittings with valves only two years old being changed due 
to degradation.  

At the site visit the design intent, configuration, operation, material/product suitability 
and control strategy for the pre-heat of make-up water system were discussed with 
the Trust, with a view to the Trust reviewing these aspects of the water system.  
It was also fed back to the Trust at this site visit that the larger press-fit fittings that 
had been used on the system needed further investigation. This was due to the 
potential for the fittings to retain a quantity of stagnant water that would be against a 

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 polymeric seal which could prove an ideal habitat for bacterial growth and would be 
virtually impossible in normal use to clean/sanitise. In turn this may lead to a harbour 
area where NTM’s could grow and be pushed into the flow stream in the pipe and 
detach and contaminate the system. These fittings are approved under the Water 
Regulations Approval Scheme, but this does not mean that there is any evidence of 
their suitability for healthcare applications.   
Ongoing work to support required changes continues. A follow-up site visit is in the 
process of being arranged with the Trust.  

Background to HTM 04-01 

HTM 04-01 was published by the Department of Health and Social Care (DHSC) in 
2016, but responsibility for this guidance transferred from the DHSC to NHS England 
in 2017.  

HTM 04-01 provides guidance on the legal requirements, design applications, 
maintenance and operations of hot and cold-water supply storage and distribution 
systems in all types of healthcare premises. It also provides advice and guidance on 
the control and management of the risk posed by water borne pathogens within a 
healthcare setting such as Pseudomonas aeruginosa, Stenotrophomonas 
maltophilia, Mycobacteria as well as Legionella. 

The guidance on the control of waterborne pathogens is divided dependent upon the 
route of administration of the infection. For instance, with Legionella there is no 
evidence of patient-to-patient or patient-to-outlet transfer, whereas Pseudomonas 
aeruginosa and Mycobacteria may be transferred to and from outlets and the water 
from both patients and staff. 

Part C of HTM 04-01 focuses on additional measures that should be taken to control 
and minimise the risk of Pseudomonas aeruginosa. Whilst the main focus of Part C 
is on the control of Pseudomonas aeruginosa, given this is the most common 
pathogen, the document explicitly states that it may also have relevance to other 
waterborne pathogens such as atypical Mycobacteria. There are many different 
species of Pseudomonas and Mycobacteria. M abscessus, the subject of the PFD, is 
a species of Mycobacteria and is also referred to as a NTM.   

Commissioned review  

NHS England is committed to improving patient safety and has therefore taken your 
concerns extremely seriously. As a result, we have commissioned Dr Susanne 
Surman-Lee to undertake the following work:  

1.  To  carry  out  a 

review  of  HTM  04-01  specifically 

to 
immunosuppressed  patients  and  NTM,  to  determine  if  HTM  04-01  contains 
suitable  advice  regarding  testing,  and  to  ensure  any  additional  required 
measures are identified;  

relation 

in 

4 

 
 
 
 
 
 
 
 
 
 
 2.  The above review is to include identification of any specific measures required 

for new hospital premises; and  

3.  To carry out a gap analysis between British Standard BS 8580-2:2022 on Water 
Safety and HTM 04-01 with respect to safe water in healthcare premises.  

 is a leading expert in the detection, survival and control of 

pathogenic microorganisms, especially the prevention of infections from 
opportunistic waterborne pathogens, with unique experience in dealing with 
healthcare building water systems.  

Any suggested amendments to HTM 04-01 which derive from this review will be 
carefully considered, and appropriate amendments will be written into a technical 
bulletin, which in turn will be published to ensure HTM 04-01 is accurate and up to 
date. The aim is to publish the technical bulletin by the Spring.  

I hope this is of assistance, and please let me know if there is anything else NHS 
England can assist you with in this matter.  

Yours sincerely  

National Medical Director   
NHS England  

Cc. 

, Director of Estates and Head of Profession at NHS England  

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