Anna Elliot

Office of the Chief Medical Officer 
Trust Headquarters 
Robert Dolan House 
5th Floor 
9 Alie Street 
London E1 8DE 

Telephone: 
Email:  

Website: http://www.elft.nhs.uk  

Private & Confidential 

HMC Melanie Lee 
By email only: 

24 September 2024 

Dear Madam  

RE: REGULATION 28 REPORT  

1.  This is a formal response to your Regulation 28 report issued on 18 July 2024 where you set out 
concerns relating to the care of late Ms Anna Elliott under the East London NHS Foundation Trust’s 

(the ‘Trust’s’) care. 

2. 

I  understand  that  at  the  inquest  into  Ms  Elliott’s  death,  you  heard  evidence  from  the  Trust’s 

Borough  Lead  Nurse  (‘BLN’)  for  Tower  Hamlets  outlining  the  learning  that  has  taken  place 

because of her death. I understand that you remained concerned about the risk of future deaths 

in relation to the following areas: 

Concern 1 – Record Keeping 

Concern 2 – Quality of Observation Records 

Concern 3 – Missed Observations 

Concern 4 – Falsified Observations 

Concern 5 – Safety Plans 

3. 

I am writing to assure you and the family of Ms Elliott that the Trust has carefully reviewed the 

issues highlighted within the Regulation 28 Report and has planned the actions outlined below. 

RESPONSE 

Concern 1: Record Keeping  

4. 

I was concerned to hear evidence that there were several areas with record keeping issues.  I 

will address these in turn.  

Chief Executive: 

Chair: 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Phone calls to Home Treatment Team regarding patients 

5.  The Tower Hamlets Crisis Services acknowledge that on 23 November 2021 the calls made by Ms 
Elliott’s  mother  to  the  Home  Treatment  Team  (HTT)  were  not  recorded  in  the  RiO  medical 

records or passed on.  

6.  Steps  are  now  in  place  to  ensure  calls  are  not  missed:  the  administrators’  office will  now  be 
covered with admin staff during the team handover from 14:00 to 16:00 to ensure calls are not 

missed.  

7. 

8. 

In addition, HTT staff will be offering carers and significant others a check-in/follow up call for 

support as needed. An escalation process has been put in place to improve communication within 

and outside of the team.  

It is now the case that the shift co-ordinator has the patient/carer phone at all times or allocates 

it to a named staff member whose identity is then documented on a log for reference. 

Patient progress notes 

9.  There  will  inevitably  be  cases  of  human  error  where  entries  may  be  recorded  incorrectly. 
Currently, the Management of Incorrect Entries Policy sets out how to remove an incorrect entry. 

Members of staff detecting an incorrect entry should take steps to correct it as per the policy.  

10.  The Trust has a robust Clinical Record Keeping Policy in place. The auditing functions behind a 
RiO progress note entry contain detailed information on who made a note, on behalf of whom, 

when they made it as well as the same details for any update to that note. This effectively serves 

as an electronic signature on that note.  

Smartcards 

11.  I was concerned to learn that some staff members were not following data protection guidelines 
through sharing log in details with other staff members and leaving smartcards unattended. When 

joining the Trust, staff are issued a smartcard and they will receive information on how to keep 

their smartcard safe; this includes never allowing anyone else to use it. This message is further 

reiterated in RiO training sessions.  

12.  Data Security Awareness training also covers managing devices. As of 3 September 2024, Tower 
Hamlets  training  compliance  with  this  training  is  currently  94.27%.  The  Directorate  has  since 

reminded staff on how to keep smartcards safe (via email on 2nd September 2024) with a plan for 

Matrons to reiterate this message at Away Days (team meetings) by the 30th of November 2024.  

Chief Executive: 

Chair: 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Handover documentation 

13.  Tower Hamlets is currently working on creating a standardised handover template. This project 
is being led by the Deputy Borough Lead Nurse. The aim is to have a running document over a 24-

hour period. The handover template has been tested on some of the wards and is currently being 

rolled out to the remaining wards. Roll out should be completed by the end of September 2024. 

The Matron responsible for ward will be responsible for the initial audit daily, this will be audited 

by the Lead Nurses quarterly. 

14.  In addition, the  Trust will continue to use Safety Huddles as a way of  discussion and decision 
making during a shift. Safety Huddle discussions will be documented on the handover template. 

This will ensure vital information during a shift is captured in the handover documentation.  

Concern 2: Quality of Observation Records 

15.  The expectations of recording entries in safe and supportive observation charts has been brought 

up at the Directorate’s safety discussions.  

16.  The  issues  with  the  quality  of  observations  have  also  been  discussed  with  Ward  Matrons  in 

governance meetings.  

17.  The Directorate has now adjusted spot check data to be specific around quality of observations. 

It will begin collecting data from September 2024.  

18.  It is mandatory for inpatient nursing staff to attend online training on intermittent observations 
on  ELA  (ELFT  Learning  Academy).    It  is  part  of  a  suite  of  essential  training  and  also  includes 

Honesty in Documentation training. Compliance is monitored via individual staff ELA records or 

monthly training reports.   

19.  The  Trust  is  currently  developing  a  new  E-observations  (e-obs)  platform  which  has  in-built 
prompts  to  ensure  staff  capture  the  location  of  a  patient,  what  they  observe  and  their 

interactions with a patient.  Daily spot checks will be undertaken by the clinical nurse manager 

or the most senior nurse on shift out of hours. It is hoped that this will be in place in the coming 

six months. 

Chief Executive: 

Chair: 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Concerns 3 and 4: Missed and falsified Observations 

20.  I apologise that the most up to date data was not provided during the inquest hearing in relation 
to missed observations. It has come to my attention that the data from an old presentation was 

used. Going forward we are using power BI (a Microsoft data application) to capture up-to-date 

information in a consistent and easily accessible fashion.  

21.  The Trust has undertaken (and continues to undertake) a significant amount of work in relation 

to both missed and falsified observations. Tables setting this out are provided below.  

Improvement work already undertaken at the time of writing  

Overarching theme    Therapeutic engagement and observation improvement work undertaken   

Staffing/ 
availability   

resource 

Staff  establishment  reviews  were  undertaken  in  22/23  and  23/24.    Correct  and  agreed 

investments have gone into teams, increasing staff on each shift by one unregistered Band 

3.  Additional  investment  has  been  made  for  a  Band  4  Life  Skills  Recovery  Worker  on 

Mondays to Fridays 9am to 5pm to increase the delivery of activities and opportunities for 
meaningful engagement.   

A  proactive  recruitment  campaign  has  been  ongoing  with  services  moving  to  zero 

registered vacancies and a review of the unregistered workforce (correct band and skill).   

Staffing  rotas  for  the  wards  have  been  reviewed  and  updated  to  reflect  safer  staffing 

requirements;  senior  approval  of  rotas  is  required  six  weeks  in  advance  of  the  current 
period and quarterly rota monitoring meetings are in place.   

Escalation  protocols  have  been  developed  for  use  to  guide  staff  when  there  are  not 
sufficient resources in place to meet care needs.   

Chief Executive: 

Chair:

 
 
 
 
 
 
 
 
 
 
 
 
   
   
 Staff competency   

The Inpatient Safety Suite of training  is now ‘live’ and classed as essential for all inpatient 
nursing staff. This gives the ability to have oversight of compliance via Trust-wide training 
reporting. This suite includes training on observations and honesty in documentation.   

Honesty in Documentation training was developed in Dec 2023 and rolled out face to face 
across all inpatient services over the period from December 2023 to April 2024.   

A pilot of Trust-wide clinical induction started in August 2024. Prior to this, comprehensive 

clinical  inductions  were  being  done  in  directorates.  This  Trust-wide  approach  supports 

consistency of material and ensures core learning on commencement of clinical roles. Non 

substantive staff (bank staff) are booked to attend and have access to protected study time 
to achieve the same competencies as substantive staff.  

Trust-wide  learning  lessons  seminars  open  to  all  staff  focus  on  areas  of  learning  and 
improvement from incidents or identified areas of good practice.  

Safety  discussion  sessions  are  facilitated  weekly  in  directorates  for  all  inpatient  staff  to 
review observation data, reflect on gaps in practice and disseminate learning.   

Time  to  Think  forums  in  directorates  are  well  established.    These  are  held  monthly  in 

directorates, led by lead nurses and are open to all staff within the inpatient service. They 

are  a  protected  resource  for  teams  to  reflect  on  their  practice,  understand  work  as  it 

happens  using  data  and  clinical  examples,  and  generate  discussions  to  inform  learning 
and next steps.   

Chief Executive: 

Chair: 

 
 
 
 
 
 
   
   
  
   
   
  
 Quality improvement   A  Trust-wide  Quality  Improvement  programme  which  involved  all  54  wards,  their  staff 

teams  and  service  users  across  the  Trust,  and  ran  over  a  period  of  18  months,  was 

undertaken from September 2022 and led to three agreed interventions. The aim was to 

improve  consistency  of  completed  observations  and  shift  the  culture  of  observation 
practice. The three change ideas agreed to move into standard practice were:  

  Board relay- this idea is based on the concept of a baton relay – you never let go 
of the baton until you pass it onto the next person. The board relay is related to 

general observations and intermittent observations only and aims to reduce the 

risk  of  observations  being  missed  and  improve  handover  of  clinical  information 

 

 

between staff undertaking the observations  

Twilight shifts- this shift pattern adds an extra member of staff to requirements for 

a shift. The hours reflect periods where there is reduced structured activity (after 

5PM) and covers the early part of a night shift. Staff undertaking these shifts lead 

on offering therapeutic interventions in the form of activities to service users on 

the ward.   

Zonal  observations-  zonal  observations  allows  an  alternative  method  of 

observation,  which  involves  designating  the  ward  into  different  zones  where 

allocated staff observe and engage with patients individually and as groups for 

set periods of time. This is to allow for continuous engagement with patients and 

monitor  environment  and  patient  dynamics  over  a  12hour  shift.  Zonal 

observations can be plotted against certain times or functions dependent on the 

ward layout and key tasks relevant to the service user group  

A  digital  application  to  document  observations  (using  Microsoft  PowerApps)  has  been 

developed and is in the testing phase. It is planned that this will be piloted from October 
2024 on four wards and then scaled across all inpatient units.   

Standards 

of 

Expected standards of practice have been communicated to staff, with frequent updates 

professional practice  

on improvement work since 2021 to date. In 2023, this specifically addressed accountability 

and responsibility for accurately documenting observations. It included the importance of 

honesty  in  documentation  and  gave  guidelines  for  staff  to  follow  for  occasions  when 

observations  were  missed.  The  Trust-wide  Quality  Improvement  programme  described 

above has introduced the observation relay board to reduce incidents of observations being 
left or not handed over.   

Audit and monitoring   The Standard Observation Measurement (SOM) Tool was developed for oversight of rates 

of completion of all observations. Individual ward teams and directorates can access and 
use their data to drive continued improvement.  

Local governance systems exist to ensure changes to practice are embedded.    

Night visits are undertaken by senior staff in directorates to monitor practice through spot 
check audits and observing work as it happens.  

Chief Executive: 

Chair: 

 
 
 
 
 
 
   
   
   
   
   
 Inpatient 

Ward 

Since 2023 a new safety culture self-assessment process has been incorporated into the 

Safety 
Culture 
Improvement Work   

Quality Assurance annual review process for each in-patient team across ELFT. Annually, 

staff complete an anonymous survey based on each component safety culture element.  A 

bespoke team report on the safety culture results is then shared back to directorates and 

teams (where enough responses are received) with advice/signposting to where steps can 

be taken to strengthen safety culture. The survey tool results are then discussed in team 

away-days  and  meetings  with  teams,  enabling  local  leaders  to  focus  on  areas  where 
improvements need to be made.  

All of our mental health inpatient wards have been participating in this process, with good 

engagement and over 800 responses have been collected from across all directorates and 

wards.  Next steps are to seek service user perspectives to triangulate and strengthen the 
safety culture intelligence available to the teams.  

The Trust is involved in the Cavendish Square community of practice attended by Chief 

Nurses  and  are  applying  to  enrol  in  a  new  NHS  England  90-day  collaborative  around 
Enhanced Therapeutic observations. 

Further planned improvement work   

Areas  for  further 
development   

Recommended improvement work   

Staffing/  resource 
availability   

Continue  to  review  escalation  protocols  to  senior  staff  on  site  in  response  to  changes  in 
acuity or demand or if there are staff shortages on a shift.  This is to include:   

Task prioritisation and allocation;   

 
  A  mechanism  for  swift  deployment  of  resources  to  meet  demand  and  robust 

reporting where care delivery is compromised.   

knowledge 

Staff 
and capability   

To  improve  the  robustness  and  governance  of  systems  for  the  temporary/bank  nursing 

workforce.  This  would include  better  oversight  of  training compliance  and  support  offered 
(supervision and reflective practice).   

Continued work on honesty in documentation.    

Chief Executive: 

Chair: 

 
 
 
 
 
 
   
   
 
 
 
   
   
 Professional 
practice   

Review and relaunch use of SOM tool and outputs to impact on practice.   

Further explore possible tools for assurance against falsification of observation that does not 

rely  on  CCTV,  although  this  may  be  difficult  to  design.    This  should  include  a  review  of 
national improvement workstreams.   

A review of night-shift culture engaging staff and service users and observing work as done. 

Design standards for night shift practice and a mechanism for assurance including senior 
night visits.    

A review of findings from the service user experience of observations qualitative audit tool.   

The introduction of the Loop App will ensure that only staff with the required competencies 
for each clinical area are able to book onto bank shifts.   

Building on the Quality Improvement work around therapeutic engagement and observations, 

in June 2024 ELFT commissioned an external Human Factors and Patient Safety Consultant 

to undertake an analysis of observations practice on our mental health In-Patient Wards to 

better  understand  observations  practice  from  a  human  factors/systems  approach,  and  to 

provide redesign ideas to address any gaps, pain points and workarounds that exist. Once 

the  work  has  been  completed,  senior  leadership  review  of  the  findings  and  suggested 
improvements of the Human Factors Analysis work.  

Communication   

To  continue  the  Trust-wide  campaign  and  consistent  program  of  communications  to  staff 

discouraging the falsification of observations, encouraging honest reporting and improving 
staff awareness of reporting requirements for missed observations.   

Observation 
practice   

To maintain involvement in the Cavendish Square community of practice attended by Chief 
Nurses to develop new approaches and adopt learning  

Developing the second phase of quality improvement work to include collaborative work with 

the  whole  MDT  to  identify  alternatives  to  observations  during  working  hours.    This  would 

require  a  significant  cultural  shift  away  from  observations,  which  will  require  a  significant 
project to be undertaken Trust-wide.   

Learning system    To develop a learning system that includes learning from incidents and improvement work 

internally, but that also links in with national work in relation to observations practice.   

To  design  an  internal  governance  process  for  the  review  of  reported  cases  of  missed 

observations  and  learning  that  arises  from  this,that  will  report  into  the  Patient  Safety  and 
Quality Assurance committees.    

An Executive-led improvement board will monitor actions and agreed plans.    

Chief Executive: 

Chair: 

 
 
 
 
 
 
 
   
  
   
   
  
   
   
   
 Standardised 
processes   

To develop a consistent approach to supporting staff to learn from incidents involving poor 

observations  practice  through  reflection,  personal  accountability  and  if  indicated  onward 
referral to regulatory body. This will be followed in parallel to the Trust Disciplinary process.   

Electronic 
Observations 

The e-obs platform being developed will support with improving completion of observations 

as the system will record any delayed observations records that are entered, reducing the 

risk  of  falsification.  All  entries  will  be  time  stamped.  It  will  alert  staff  on  the  shift  once 

prescribed  observations  are  overdue  by  5  or  more  minutes;  reducing  the  risk  of  missed 

observations. Each staff member will have their own log in for the app and any observations 

they complete will reflect this- staff should not be able to use other people's log in to falsely 

record  observations  completed.  On  the  app  each  patient's  observation  care  plan  will  be 

linked to their record of observation. This ensures continuity of care. Any reviews in level of 

observations will require an entry to be made verifying the escalation and decision-making 
process. 

Concern 5: Safety Plans 

25.  In Tower Hamlets the Trust has introduced Dialog+ Plus and Safety Planning training facilitated 
by  Trust  Matrons.  We  have  a  monthly  schedule  where  inpatient  staff  in  Tower  Hamlets  must 

attend Training covering Dialog+ care planning, safety plans and risk formulations.  Staff have an 

opportunity to practice using scenarios in groups. 

Conclusion 

26.  I hope this response provides sufficient reassurances to you and to the family of Ms Elliott about 

the additional learning that has taken place at the Trust because of her sad death.  

27.  I would like to offer my sincere and heart-felt condolences to her family at this difficult time.   

Yours sincerely 

Chief Medical Officer 

Chief Executive: 

Chair: