Mary Brady

HSCA Further Information 
Citygate 
Gallowgate 
Newcastle upon Tyne 
NE1 4PA 

Telephone: 03000 616161 
Fax: 03000 616171 

www.cqc.org.uk 

4th June 2020 

Alison Mutch OBE 
HM Senior Coroner 
1 Mount Tabor Street 
Stockport 
SK1 3AG 

Via email: coroners.office@stockport.gov.uk 

Our Reference: MRR1-8843638527 
Your reference: 312488 

Dear HM Senior Coroner Alison Mutch OBE, 

Prevention of future death report following inquest into the death of Mary Brady 

Thank  you  for  sending  CQC  a  copy  of  the  prevention  of  future  death  report  issued 
following the sad death of Mary Brady. 

We  note  the  legal  requirement  upon  the  Care  Quality  Commission  to  respond  to  your 
report within 56 days, by the 19th June 2020. 

The registered providers of Balmoral Care Home at the time of Mrs Brady’s death were 
Mr 
  Since  then  a  new  provider,  Cartwright 
Care Balmoral Management Limited has been registered to carry on the home.   

  and  Mrs 

The  provider  location  registered  with  CQC  is  located  at  29  Old  Road,  Mottram,  Hyde, 
Cheshire  SK14  6LW.  The  provider 
regulated  activity: 
is 
Accommodation for persons who require nursing or personal care 

registered 

the 

for 

The role of the CQC & Inspection methodology  

The  role  of  the  Care  Quality  Commission  (CQC)  as  an  independent  regulator  is  to 
register  health  and  adult  social  care  service  providers  in  England  and  to  inspect 
whether or not the fundamental standards are being met.   

Our  current  regulatory  approach  involves  inspectors  considering  five  key  questions.  
They ask if services are Safe; Effective; Caring; Responsive; and Well Led.  Inspectors 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 use  a  series  of  key  lines  of  enquiry  (KLOEs)  and  prompts  to  seek  and  corroborate 
evidence  and  reassurance  of  how  the  provider  performs  against  characteristics  of 
ratings  and  how  risks  to  people  are  identified,  assessed  and  mitigated.    Sources  of 
evidence  for  the  KLOEs  can  be  found  on  our  website  along  with  our  KLOEs  and 
characteristics of ratings. 

The  regulatory  framework  includes  providers  being  required  to  meet  fundamental 
standards of care, standards below which care must never fall.  We provide guidance to 
providers  on  how  they  can  meet  these  standards  (Regulations  4  to  20A  of  the  Health 
and Social Care Act 2008 (Regulated Activities) Regulations 2014).  

Background 

On  11  March  2019  the  police  (GMP)  contacted  CQC  to  advise  us  of  the  unexpected 
death of Mary Brady at Balmoral Care Home on 10 March 2019 and to inform us that a 
safeguarding  meeting  had  been  held  and  they  were  investigating  this  matter.    We 
received  a  statutory  notification  from  the  registered  provider  on  11  March  2020.  This 
stated that Ms Brady was found unconscious on the evening of 10 March 2019 and that 
when the paramedics attended, they found she had ingested a plastic glove.  

Further  information  was  requested  from  the  registered  provider  including  the  service’s 
PPE / Glove disposal procedure and any risk assessments in place at time of incident 
and details of whether any of those had been amended in light of the incident. We also 
requested the training matrix for all staff including first aid and CPR, names of the staff 
on duty, the staff rota covering the weekend 10 and 11 March 2019 and a copy of the 
action plan completed for Tameside council following the incident.  

During a review of the information held about this incident it was noted that the service 
was  inspected  shortly  before  the  incident  and  rated  good.  The  process  for  disposal  of 
gloves was in place and staff confirmed they were trained and understood the process. 
Staff  had  also  confirmed  this  in  statements  to  GMP.  The  presence  of  open  waste 
baskets could not, in themselves, be attributed as a causal factor in Mrs Brady’s death, 
nor  staff  failures  to  escalate  previous  risk  behaviour  such  as  other  incidents  where 
professionals had failed to safely dispose of clinical waste, or previous incidents where 
Mrs Brady had been found with non-food items in her mouth. The incorrect disposal of 
gloves allowed Mrs Brady to have access to, and subsequently ingest these gloves; this 
was a primary factor in Mrs Brady’s death. However, CQC were of the opinion that the 
registered  persons  had  taken  reasonable  steps  to  ensure  the  safe  disposal  of  gloves. 
We  have  reviewed  the  action  plan  developed  by  Balmoral  Care  Home  and  local 
authority  and  are  satisfied  that  enough  action  has  been  taken  in  response  to  reduce 
further  risks  within  this  care  home.  This  will  be  reviewed  at  our  next  inspection  of  the 
service.  

Regulatory History 

2 

 
 
 
 
 
 
 
 
 
 
 
   and  Mrs 

  were  registered  to  carry  on  a  regulated 
Mr 
activity at Balmoral Care Home in February 2011. Mrs Brady was admitted to the care 
home on 26 February 2019 and just prior to that on 12 and 14 February 2019 we had 
carried out a comprehensive inspection of the service.  The service was rated as good 
with no breaches of regulations being identified.  

As  noted  earlier,  the  provider  for  this  care  home  has  changed  since  the  inquest  and 
Cartwright  Care  Balmoral  Management  Limited  are  now  the  registered  provider  and 
were  registered  with  the  CQC  on  02/04/2020.  This  means  that  under  our  current 
inspection methodology the service, as a newly registered service, would be inspected 
by April 2021, but earlier if concerns were raised about the safety and welfare of people 
receiving the service. 

Matters of concern 

1.  The  home  at  the  time  of  Mrs  Brady’s  death,  in  common  with  many 
similar  establishments  had  open  waste  paper  baskets 
in  the 
communal  areas.  Residents  with  dementia  were  left  unsupervised  in 
these  areas  and  there  was  always  a  risk  that  they  might  access 
material from these waste baskets. In this case the gloves should not 
have  been  in  the  bin  at  all  but  there  were  other  items  in  there  which 
could have presented a choking hazard. The home had since removed 
all  open  waste  baskets  from  communal  areas  to  avoid  the  risk.  The 
inquest  was  told  that  similar  baskets  were  common  in  care  homes 
nationally.  

In  accordance  with  CQC’s  regulatory  remit,  as  with  other  regulators,  we  highlight 
breaches of the regulations to a Provider and where appropriate ask them what they are 
going to do to make improvements. We do not tell them what they should do. That is for 
the Provider and/or Registered Manager (‘registered person’) to decide.  

CQC does not publish detailed standards and expectations about specific conditions. To 
do so would duplicate the work of more appropriate expert sources (for example NICE 
and  SCIE). We  expect  registered  persons  to  keep  up  to  date  with,  take  on  board  and 
implement good practice standards provided by relevant authoritative organisations. We 
are  not  currently  aware  of  any  good  practice  guidance  in  relation  to  the  use  of  open 
waste baskets relevant to this type of setting.  

Our regulatory duties in this case would be under regulation 12 Safe care and treatment 
2  (e)  ensuring  that  the  equipment  used  by  the  service  provider  is  safe  to  use  for  its 
intended  purpose  and  is  used  in  a  safe  way  of  the  Health  and  Social  Care  Act  2008 
(Regulated Activities) Regulations 2014. 

One  of  the  KLOEs  for  answering  ‘Is  this  service  Safe’  asks:  How  are  risks  to  people 
assessed, and their safety monitored and managed, so they are supported to stay safe 
and their freedom respected? Inspectors explore the arrangements in place to manage 

3 

 
 
 
 
 
 
 
 
 
 
 
 risk appropriately and examine how people, their family, and other carers are involved in 
planning,  managing  and  making  decisions  about  any  risks 
take. 
Furthermore,  risk  management  policies  are  reviewed  to  look  at  how  these  minimise 
restrictions  on  people’s  freedom,  choice  and  control,  for  people  who  lack  mental 
capacity. All KLOEs were reviewed following CQC’s inspection methodology during the 
inspection of the service in February 2019. 

they  might 

The  death  of  Mrs  Brady  was  reviewed  as  part  of  our  regulatory  duties,  to  assess 
whether there was any evidence of  failings by a registered person that  amounted to a 
breach  of  the  Regulations.  The  conclusion  of  this  review  found  that  there  was 
insufficient  evidence  of  a  breach  of  the  Regulations.  The  CQC  view  was  that  the 
presence of open waste baskets could not in themselves be causally linked to the death 
of Mrs Brady and that Mrs Brady’s death was the result of individual staff error (failure to 
dispose of clinical waste appropriately) rather than a failure by a registered person.   

Furthermore,  CQC  is  aware  that  the  action  plan  developed  with  Tameside  local 
authority has led to the removal of all open waste bins within Balmoral Care Home and 
has  reduced  any  ongoing  risk  in  this  area.  Whilst  risk  of  people  living  with  dementia 
ingesting non food items can never be fully mitigated, CQC believe the actions taken by 
the provider are what could reasonably be expected of them.  

To ensure that this risk is minimised to the lowest possible level, this will be reviewed by 
CQC  at  the  next  inspection  which  under our current  inspection  methodology  would  be 
by April 2021 at the latest. 

2.  The gloves were clinical waste and had been disposed of other than in 
the clinical waste bin in the secure area. The inquest heard that  there 
had been previous instances of used gloves being found in the waste 
baskets.  However,  the  issue  had  not  been  escalated  to  senior 
managers and no steps had been taken to avoid the issue reoccurring. 

CQC  expect  all  services  to  have  robust  systems  to  ensure  the  quality  of  service  and 
monitor  that  policies  and  procedures  are  being  followed.  At  the  last  inspection  of 
Balmoral  Care  Home  in  2019  it  was  found  there  were  a  variety  of  safety  checks  and 
audits  carried  out  in  the  home to  ensure  it  was  safe for  the  people  living  there. These 
were  overseen  by  the  registered  manager  to  ensure  any  actions  were  completed. We 
have reviewed all the notes from this inspection and the inspection team had not been 
made  aware  at  that  time  that  there  were  incidents  when  staff  were  not  following 
procedures or that staff failed to highlight risk and concerns when these were identified.  

CQC  is  aware  that  multiple  sets  of  disposable  gloves  and  clinical  waste  was  found  in 
the waste basket at the time of Mrs Brady’s death but it is not clear what was actually 
present  prior  to  the  death  and  what  was  placed  in  the  basket  when  the  incident  was 
responded to. We are also aware that there had been previous instances where gloves 
were found in the waste basket as part of the information Balmoral Care Home shared 
within  safeguarding  meetings  following  Mrs  Brady’s  death.  The  information  from  the 

4 

 
 
 
 
 
 
 
 
 
 
 home  stated  that  there  were  two  separate  incidents  whereby  health  professionals had 
disposed of their clinical gloves incorrectly. 1) by a paramedic who had left their gloves 
for  the  home  care  to  dispose  of  and  2)  again  by  a  paramedic  who  left  clinical  gloves 
after  treating  a  resident  in  their  bedroom.  External  health  care  services  will  have  their 
own policies and procedures for disposing of clinical waste, such as disposable gloves, 
when visiting community settings and care homes. It would be the visiting professional’s 
responsibility to safely dispose of their own clinical waste.  

It would be good practice for staff to discuss such incidents with the manager so these 
could  be  addressed  at  a  senior  level.  There  were  clear  policies  for  the  disposal  of 
gloves  and  all  staff  were  aware  of  the  correct  procedure.  Therefore,  any  failure  to 
dispose  of  gloves  appropriately  (or  escalate  incidents  where  gloves  had  not  been 
appropriately  disposed  of)  does  not  seem  to  be  attributable  to  failings  of  a  registered 
person. The CQC understood that these previous incidents were dealt with as  isolated 
incidents  and  were  not  considered  to  be  a  trend  or  ongoing  risk  presented  by  visiting 
external health care services.  

It has not been possible to resolve the issue of where the gloves ingested by Mrs Brady 
on the 10th March 2019, came from. All care staff stated they were aware of the correct 
procedure for disposing of gloves and deny having used the waste basket to dispose of 
their gloves.  

CQC are aware that the action plan developed with Tameside local authority has led to 
a new policy on the use of PPE and new system of checks for the use and disposal of 
PPE.  

To ensure that this risk is minimised to the lowest possible level, this will be reviewed by 
CQC at  the  next  inspection  which  under our current  inspection  methodology  would  be 
by April 2021 at the latest. 

3.  Mrs  Brady  had  been  seen  putting  non-food  items  in  her  mouth  by 
staff.  These  instances  had  not  been  appropriately  documented  and 
level  of  risk  she  presented  was  not  fully 
risk  assessed.  The 
understood as a result and her care plan was not updated. 

Our regulatory duties in this case would be under regulation 12 Safe care and treatment 
2 (a) and (b); assessing the risks to the health and safety of service users of receiving 
the  care  or  treatment  and  doing  all  the  is  reasonably  practicable  to  mitigate  any  such 
risk of the Health and Social Care Act (2008). 

We  look  at  how  risk  is  managed  under  Assessment  Framework  key  question  “Is  the 
service  Safe?”  The  framework  has  ‘Key  Lines  of  Enquiry’  (KLOEs)  for  inspectors  to 
follow  when  answering  the  key  questions. One of the  KLOEs for  ‘Safe’  asks:  How  are 
risks  to  people  assessed,  and  their  safety  monitored  and  managed,  so  they  are 
supported 
the 
arrangements  in  place  to  assess  and  manage  risk  appropriately  and  examine  how 

freedom  respected? 

to  stay  safe  and 

Inspectors  explore 

their 

5 

 
 
 
 
 
 
 
 
 
 
 
 people,  their  family,  and  other  carers  are  involved  in  planning,  managing  and  making 
decisions about any risks they might take. 

We look at how an individual’s needs are managed under Assessment Framework key 
question  “Is  the  service  Responsive?”  The  framework  has  ‘Key  Lines  of  Enquiry’ 
(KLOEs) for inspectors to follow when answering the key questions. One of the KLOEs 
for  ‘Responsive’  asks:  How  do  people  receive  personalised  care  that  is  responsive  to 
their  needs.  Inspectors  the  arrangements  in  place  to  develop  care  plans  that  are  fully 
reflective of people’s physical, mental, emotional and social needs.  

Mrs Brady was admitted to Balmoral Care Home on the 26th February 2019 and 12 days 
later, on the 10th March 2019, was found unresponsive in the communal lounge.  

Care plans are subject to continual review and assessment of individual’s need and are 
ongoing.  CQC  would  expect  that  care  plans  completed  during  the  initial  period  of 
admission relating to Mrs Brady’s care would be subject to continual review whilst staff 
developed a fuller understanding of Mrs Brady’s needs and risks. It is good practice for 
care staff to escalate any unusual behaviours to senior staff so that this could be more 
fully assessed.  

CQC is satisfied that the management of risk at this service, based on our inspections 
prior to Mrs Brady’s admission, where broadly speaking, care plans and risk 
assessments were reviewed and deemed adequate. The CQC is not aware of any 
specific national good practice guidance to guide staff in this area and arrangements will 
vary across different providers of services. There is some anecdotal evidence that it is 
not uncommon for people living with dementia to place non-food items in their mouths. 
However, there is limited research in this area and dementia care training does not 
typically cover this unlike dysphagia training. 

In  Mrs  Brady’s  case  the  escalation  of  unusual  behaviours  did  not  occur  as  individual 
care  staff  did  not  recognise  the  significance  of  this  risk  and  saw  this  behaviour  in 
isolation.  

The  CQC  is  satisfied  that  appropriate  steps  have  been  taken  to  ensure  that  staff 
recognise  risks  from  choking  and  document  them  appropriately.  This  is  based  on  our 
previous knowledge of this  location, how they have responded to this incident and the 
input from Tameside Local Authority in developing an action plan. 

CQC  is  aware  of  the  action  plan  developed  with  Tameside  local  authority  which  has 
included  1)  New  handover  sheets  which  clearly  highlight  risks  for  each  resident  and 
clarify staff members responsibilities during the shift; 2) daily communication meeting for 
domestic workings; 3) Reviews of daily/ weekly/monthly environment risk assessments. 
CQC  is  of  the  opinion  that  the  new  processes  that  the  service  have  adopted  have 
addressed the known risks in this care home.  

6 

 
 
 
 
 
 
 
 
 
 
 
 
 In  order  to  ensure  that  that  this  risk  is  minimised  to  the  lowest  possible  level  and  to 
ensure service users are not placed at risk at Balmoral Care Home, we are continually 
monitoring  the  service  and  liaising  with  the  local  authority  to  review  any  ongoing  risks 
and  feedback.  In  addition,  the  action  plan  will  be  reviewed  by  CQC  at  the  next 
inspection  which  under  our  current  inspection  methodology  would  be  by  April  2021  at 
the latest. 

In summary the requirement is placed on providers and registered managers to ensure 
that  they  are  delivering  care  in  a  safe  way  and  doing  all  that  is practicable  to  mitigate 
any risks. CQC will continue to review through its inspection processes the systems and 
processes  being  operated  by  those  services  it  regulates  and  will  challenge  and  if 
appropriate  take  enforcement  action  against  the  registered  person  where  it  finds  that 
care is being provided in an unsafe way.  

Should you require any further information then please do not hesitate to get in touch.    

Yours sincerely, 

Interim Head of Inspection North West – Adult Social Care 

7

Your Ref: 312488 
Our Ref: PFD-1219459 

Ms Alison Patricia Mutch 
HM Senior Coroner, Manchester South 
HM Coroner's Court 
1 Mount Tabor Street 
Stockport SK1 3AG 

From Helen Whately MP 
Minister of State for Care 

39 Victoria Street 
London 
SW1H 0EU 

020 7210 4850 

17 June 2020 

Thank you for your letter of 24 April 2020 about the death of Mary Brady.  I am replying as 
Minister with responsibility for adult social care. 

Firstly, I would like to say how saddened I was to read of the circumstances of Mrs Brady’s 
death and I extend my sincere condolences to her family and loved ones on their loss.  It is 
important that we take the learnings from Mrs Brady’s death so that people continue to 
receive the highest quality, safe care.    

The matters of concern in your report are that there was a failure to dispose of Personal 
Protective Equipment (PPE) (in this case gloves) appropriately; that the contents of open 
wastebaskets can pose a choking hazard; and, that Mrs Brady’s care plan had not been 
updated to reflect her care needs. 

You issued your report to the Care Quality Commission (CQC) and Departmental officials 
have made enquiries with the CQC on the regulatory activity in relation to this incident.  I 
am therefore aware that following a review of the circumstances of Mrs Brady’s death; 
information provided by the registered provider and the action it has taken; and the 
findings of a CQC inspection conducted in February 2019, the CQC is satisfied that 
sufficient action has been taken to reduce further risks within the Balmoral Care Home and 
that there was insufficient evidence that a breach of the Regulations1 had occurred.  The 
CQC’s response to your report provides further detail on its considerations in relation to 
this case.   

I am advised that this will be reviewed at the next inspection, which as the Home is now 
registered to a new provider, is scheduled for April 2021, unless the CQC determines an 
earlier inspection is necessary.  CQC will continue to monitor the service.    

1 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
 It is for the CQC as the independent regulator of all health and adult social care providers 
to monitor, inspect and rate services and the CQC has a range of powers it can take 
against providers when the quality and safety of services falls below the fundamental 
standards set out in Regulations.   

Registered providers and managers of services are expected to ensure they are delivering 
care safely and doing all they can to mitigate risks through the conduct of local risk 
assessments (including for example, assessing environmental risks such as those 
associated with open wastebaskets).  Providers are expected to plan care in line with good 
practice standards, such as guidance issued by the National Institute for Health and Care 
Excellence (NICE), and relevant professional and regulatory bodies.    

There is guidance on how care settings should manage the use of Personal Protective 
Equipment (PPE).  The NICE clinical guideline, Healthcare-associated infections: 
preventions and control in primary and community care (CG1392), recommends that 
everyone involved in providing care should be trained in the use of PPE, and that care 
settings should ensure that healthcare waste is disposed of in accordance with current 
national legislation and local policies.  

NICE has published a social care quick guide titled, Helping to prevent infection; A quick 
guide for managers and staff in care homes3, which is based on the NICE guideline 
CG139 and the NICE quality standard Infection prevention and control (QS614).  The quick 
guide includes a section on PPE that discusses the use of items such as gloves and 
aprons and says to “Dispose of all used items correctly”. 

In relation to ensuring care plans are updated and reflect a person’s care needs, guidance 
to support the implementation of the Care Act 20145 states that keeping plans under 
review is an essential element of the planning process.  The Act specifies that plans must 
be kept under review generally. 

Without a system of regular review, plans could become quickly out of date meaning that 
people are not obtaining the care and support required to meet their needs. Therefore, 
local authorities should establish systems that allow the proportionate monitoring of both 
care and support plans to ensure that needs are continuing to be met.  There are several 
routes to reviewing a care and support or support plan including:  

•  A planned review (the date for which was set with the individual during care and 

support or support planning, or through general monitoring);  

•  An unplanned review (which results from a change in needs or circumstance that 
the local authority becomes aware of, e.g. a fall or hospital admission); and,  

2 https://www.nice.org.uk/guidance/cg139 

3 https://www.nice.org.uk/about/nice-communities/social-care/quick-guides/helping-to-prevent-infection 

4 https://www.nice.org.uk/guidance/qs61 

5 https://www.gov.uk/government/publications/care-act-statutory-guidance/care-and-support-statutory-guidance 

 
 
 
 
 
 
 
 
 
 
                                                           
 
 
 
 
 •  A requested review (where the person with the care and support or support plan, or 
their carer, family member, advocate or other interested party makes a request that 
a review is conducted.  This may also be as the result of a change in needs or 
circumstances). 

It is the expectation that authorities should conduct a review of the plan at least once every 
12 months, although a light touch review should be considered six to eight weeks after 
agreement and sign-off of the plan and personal budget, to ensure that the arrangements 
are accurate and there are no initial issues.  This light-touch review should also be 
considered after revision of an existing plan to ensure that the new plan is working as 
intended. 

We expect all staff to have received the relevant training.  It would be very challenging to 
cover all eventualities in a care worker’s training.  However, staff are trained to work in line 
with best practice, risk management, policies and procedures.  
The Dementia Training Standards Framework6 sets out the competencies expected of 
staff across three tiers of training.  This includes a focus on person-centred care, and 
awareness of the different types of dementia, associated symptoms, and the importance of 
recognising a person with dementia as a unique individual.  In this case, I am advised that 
CQC is satisfied that appropriate steps have been taken by the Balmoral Care Home to 
ensure that staff recognise the risks from choking and document them appropriately.  

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

HELEN WHATELY 

6 https://www.hee.nhs.uk/our-work/dementia-awareness/core-skills