John Crittall

Mount Alvernia
Hospital

11 July 2016

Dr Karen Henderson

HM Assistant Coroner for Coroner Area of Surrey
HM Coroner’s Court

Station Approach

Woking

Surrey GU22 7AP

Dear Dr Henderson
Regulation 28 Report — Mr John Crittall

| am writing in response to your Regulation 28 Report of 16" May 2016 following the Inquest of Mr
John Crittall addressed to BMI Healthcare’s Chief Executive Officer, which has been passed to me to
respond.

You have asked for a response to the matters of concern raised within the report and to detail the
proposed actions to be taken by BMI Mount Alvernia Hospital, setting out the timetable for action
and an explanation where no action is proposed.

Your report was addressed to BMI Healthcare (BMI), Royal Surrey County Hospital, Royal College of
Radiologists, CQC, and GMC, being organisations that have the power to take action. Please see
below responses on behalf of BMI Healthcare Limited, which have been prepared with input from
BMI’s National Director of Clinical Services, Group Medical Director and Group Director Clinical
Governance.

Serious about health. Passionate about care.

Concern 1

The admission of an acutely unwell patient with pneumonia to a private hospital dealing
primarily with elective surgical procedures with no HDU/ITU facilities.

The most senior doctor in the hospital, other than visiting clinicians was an RMO of unclear
experience who usually has the care of more than 50 patients at any one time but can be as
many as 72.

This is alongside nursing staff who have no significant grounding in resuscitation and an unclear
understanding of chest drain insertion for pneumonic pleural effusions, usually having to deal
with malignant pleural effusions.

Response:

Admission - For admission of a patient with pneumonia to a BMI hospital without HDU/ITU facilities,
a patient’s current and previous medical and surgical history is considered to confirm that they meet
the criteria for admission to the hospital with no HDU/ITU facilities i.e. patients requiring level 0 — to
level 1 care. It is acknowledged that clinical deterioration can occur at any stage of a patient’s
pathway and the National Early Warning Score (NEWS) is a tool in use to support staff in recognising
deterioration of a patient at an early stage and escalate accordingly for medical assessment by the

Harvey Road, Guildford, Surrey GU| 3LX 1
T 01483 570122 F 01483 532554 E mount.alvernia@bmihealthcare.co.uk www.bmihealthcare.co.uk
BMI Healthcare Limited Registered in England Number 2164270, Registered office BM! Healthcare House, 3 Paris Garden, Southwark,’London SEI 8ND.

SPC709

hospital’s resident medical officer (RMO) as required. Following assessment by the RMO if
necessary, the patient’s consultant or other relevant professional, e.g. consultant anaesthetist would
be contacted for advice or asked to attend. On admission, Mr Crittall’s condition was assessed to be
level 0, an appropriate admission to the hospital

Resident Medical Officer (RMO) - The role of the RMO is to respond to requests from consultants and
nursing staff in matters which require medical input and involves the assessment of surgical and
medical patients who deviate from the treatment pathway, and deteriorating patients. RMO’s are
provided to the hospital by an agency and are provided on the basis that they are able to work
within the clinical requirements specific to the hospital, including GMC registration, a current
Advanced Life Support certificate and European Paediatric Life Support certificate and experience in
cancer care. This was the case for the RMO on duty that day.

At the time of Mr Crittall’s admission, the hospital was registered for 72 beds. However, not all of
the patient bedrooms are in use for patient admissions at any one time and in the past 3 years, the
typical in-patient occupancy has not exceeded 15 patients over the 24 hour period. On the relevant
day there were no more than 12 patients admitted to Mr Crittall’s ward and a number of other
patients in other departments within the hospital.

Nursing staff - All hospital staff receive either advanced life support (ALS); basic life support (BLS) or
immediate life support (ILS) resuscitation council accredited training. All nursing staff are ILS trained
as a minimum requirement and the current senior nursing team are ALS trained with the exception
of 1 member of the team. The requirement is for renewal every 4 years. In the intervening years
between formal ALS training all ALS qualified staff attend an ALS refresher (previously this was an
ILS, refresher).

Understanding of chest drains -While the specifics of chest drain insertion may differ according to
the condition being treated, the principles for the management of a chest drain apply both to
pneumonic pleural effusions and malignant pleural effusions.

In response, the following actions have been taken:

1. Any RMO’s offered to the hospital are required to meet specific criteria regarding previous
experience and competency and a number of RMOs have been specifically selected who are
familiar with the hospital, the consultants and nursing staff with the aim of improving
continuity of care and communication with consultants.

2. All staff and RMO’s are involved with regular unannounced resuscitation scenarios run at the
hospital by an externally appointed resuscitation training company engaged to teach
resuscitation skills to all staff. Any learning requirements are identified to staff and to the
RMOs and their agency.

3. All nursing staff and Health Care Assistants have attended AIMS (Acute Illness Management
training) and completed competencies in the care of the deteriorating patient.

4. The protocol for the care of patients with a chest drain has been updated to align with
British Thoracic Society (BTS) guidelines. Training and competencies for all radiology and
nursing staff on the understanding of chest drain insertion is currently under review by BMI
to be incorporated in the Acute care Competencies.

5. Following the feedback from the coroner we have further strengthened the process for the
management of patients with pleural infection, utilising the diagnostic algorithm for the
management of such patients as described in the BTS guidelines 2010.

Concern 2
The absence of operational protocols and a HDU/ITU facility to manage emergency situations and a
reliance on 999 call for paramedics to provide care for a hospital who undertakes such procedures

prior to transferring an unwell patient to an NHS Hospital.

Response:

The hospital has an Elective and Non-Elective Transfer Policy in place which sets out the
requirements for transfer of patients in emergency situations. The policy acknowledges that clinical
deterioration can occur at any stage of a patient’s pathway. The National Early Warning Score
(NEWS) is a tool to support staff to recognise deterioration at an early stage and escalate for medical
assessment by the RMO. If following assessment it is deemed necessary, the patients’ consultant or
other relevant professional, e.g. consultant anaesthetist should be contacted for advice or asked to

attend.

The consultant and their anaesthetist (where appropriate) and the senior nurse on duty are required
to make the decision as to whether a patient should be transferred to a critical care unit. Those
patients requiring higher dependency care wiil be transferred to a specified level 2 or 3 care within
the Critical Care Network. If a patient is unstable and their condition is life threatening, a 999 call
willbe made. The content of the policy, including the process for transfer, has been agreed with the
Royal Surrey County Hospital.

It is acknowledged that there was a reliance on the imminent arrival of a paramedic crew on the day
in question which following a significant delay to their arrival, affected certain decisions made.
However, there are facilities available at the hospital to support the stabilising of a patient prior to
transfer, which on this occasion were not utilised. A number of key points to improve future
management of a deteriorating patient were identified and have been addressed as set out below.

In response, the following actions have been taken:

1. The hospital’s Elective and Non-Elective Transfer Policy, has been reviewed and updated to
reinforce the registered level of care provided by the hospital. The process for transfer in an
emergency situation was agreed with the Medical Director at the Royal Surrey County
Hospital NHS Trust and incorporated into the policy. The policy is available for RMO and
senior nursing staff within the RMO induction and bleep holder file.

2. A local standard operating procedure (SOP) has been agreed at the hospital resuscitation
committee to reinforce the management of a critically ill patient whereby a patient is
automatically transferred to the recovery area within the hospital’s theatre complex to
ensure access to comprehensive monitoring equipment and anaesthetic staff.

3. The SOP is tested in unannounced resuscitation scenarios which allow staff to reinforce their
understanding and experience.

4. All consultant anaesthetists are aware that whilst in the hospital, the management of a
critically ill patient is a priority over elective surgical cases.

5. Where required, the consultant anaesthetist will travel with the patient.

Concern 3

The insertion of a chest drain on the 4" July was not supported by British Thoracic Society (BTS)
guidelines and was attempted on the background of an improving clinical picture without repeat of
relevant investigations (e.g. inflammatory markers) or evidence of a developing or actual empyema
or a further medical review, by either the radiologist or responsible clinician, to confirm its necessity.

Response:

The decision to proceed with the insertion of a chest drain was made by the radiologist at the
request of the admitting physician with consideration of the x-ray taken that morning.

In response, the following actions have been taken:

1. The consultant radiologist withdrew from interventional radiology following this event
having notified his responsible officer and the GMC.

2. Where, there is a failed sampling of loculated fluid, consultant radiologists are expected to
follow the BTS guidance which requests that the consultant consider CT imaging for further
image guided aspiration.

3. We have developed a pathway which provides consultants with a clear picture of the
patient’s clinical condition which will support any decision regarding the progression to an
interventional procedure.

Concern 4

| heard evidence that the insertion of a chest drain may pre-empt difficulties that may arise if Mr
Crittall deteriorated over the approaching weekend. This was contrary to expert evidence that chest
drain insertion should only be considered as a necessity and should not be influenced by the day of

the week.

Response:

The decision to insert a chest drain should not be influenced by the day of the week. The hospital is
open and staffed 24 hours a day, 7 days a week as is the Radiology department. An on call
radiographer is provided to enable procedures to be carried out whenever required. Consultants are
not expected to make such clinical decisions based on the day of the week.

Consultants are expected to follow BTS guidance when making such decisions.

Concern 5
Real time ultrasound visualisation was not used to guide the chest drain insertion against ‘best

practice’. | was led to believe ‘best practice’ was not commonly used at Royal Surrey County hospital
and in many other hospitals nationally. | also heard evidence real time ultrasound visualisation
would have assisted the insertion as the effusion was small and lay in an awkward position close to
tethering of the lung to the chest wall (which was not documented in the hospital notes or the
radiologist’s statement but was clearly present on ultrasound pictures examined by Dr Burkhill and
acknowledged to be present by the radiologist who undertook the chest drain insertion in oral
testimony).

Response:

We acknowledge the coroner’s comments on best practice. We have reviewed the BTS guidance for
the management of patients with pleural infection and have incorporated the guidance into the
patient pathway.

Concern 6
The position of the non-draining {second attempt) chest drain was not radiologically confirmed,

against expected practice, particularly as it wasn’t draining. | heard expert evidence that this
resulted in a delay in recognition and prompt management of the haemothorax which contributed
to Mr Crittall’s death.

Response:
It is acknowledged that the chest drain was not confirmed radiologically against expected practice.

In response, the following actions have been taken:

1. A Standard Operating Procedure, local to the hospital, has been developed. The procedure
reflects the requirements of best practice detailed within the BTS guidance in relation to the
requirement to consider a CT scan and further image guided aspiration following a failed
sampling or presence of a small loculated effusion.

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Concern 7

Best practice measures had not been instituted in the radiology department to safeguard patients
undergoing radiological interventions. This included completion of an appropriate consent detailing
complications, radiological indication for insertion of chest drain independent of the respiratory
consultant, a WHO checklist, no observations (BP, HR, temp, etc.) before or after the chest
procedure on a background of poor communication with the ward staff as to what plan was in place
other than an outdated protocol for management of chest drains on the ward which did not address
what actions to take if complications arose. It was held in court that if these steps were in place it is
likely that the haemothorax would have been picked up quicker allowing greater amount of time for
appropriate steps to have been taken e.g. earlier resuscitation and a direct transfer to a regional
thoracic unit.

Response:

In 2014 the WHO check list for procedures was introduced into the radiology department and is now
every day practice and all consultants were aware of the requirement to undertake a comprehensive
consent detailing risks and benefits of the procedure. Following the incident the consultant body
were reminded of the necessity to ensure that documentation is complete detailing possible
complications on each consent form. This process is subject to audit which confirms compliance with

this standard.
In response, the following actions have been taken:

1. Consultants have been reminded of the requirement to ensure completion of appropriate
consent, the radiological indication for insertion and documentation of complications on
each consent form. This process is subject to audit.

2. A patient pathway has been developed for patients undertaking this type of procedure to
ensure improved communication between staff on the ward and in radiology. The pathway
ensures base line observations are recorded prior to and following the procedure and
requires clear communication on handover.

3. The pathway includes the protocol for the management of chest drains on the ward which
addresses actions to take if complications arise.

Concern 8

The use of a 6f gauge pig tail catheter in the management of pleural effusions with or without an
empyema was against both national guidelines and expert evidence heard at inquest and was
unsupported by either international research or any recent local audits undertaken to justify their
use in preference for larger small bore chest drains.

In response, the following actions have been taken:

1. As discussed previously in the response to Concern 6, BTS guidance for the management of
patients with pleural infection is promoted which includes reference to the use of a larger
bore tube size 10-14. :

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Concern 9

The court heard evidence that there was a ‘local’ proactive approach for the insertion of chest drains
based on no objective evidence other than the belief that the very smallest catheters were safer and
more comfortable and reduced referral for surgical management of an empyema. The view was
against expert evidence at inquest and concern was raised that this approach inevitably led to an
excess of chest drains being inserted unnecessarily particularly when BTS guidelines were not being
routinely applied and/or no evidence of a developing or actual empyema.

Response:

The ‘local’ proactive approach described was specific to the consultants concerned based on their
practice and experience. There is no evidence that any other consultants at the hospital adopted
such an approach.

The consultant radiologist no longer conducts interventional work at the hospital and the consultant
physician no longer admits patients to the hospital.

As previously discussed the hospital promotes management in accordance with the BTS guidance.

Concern 10

The Radiologist did not have acute or basic life support training as would be expected for all clinical
hospital staff as part of mandatory NHS appointments.

Response:

All consultants are required to have basic life support training as a minimum. As part of the
practising privileges that are granted to consultants to allow them to practice at the hospital, annual
practice appraisals are conducted, part of which is a requirement for a consultant’s responsible
officer to confirm that basic life support training has been completed.

In 2014 the BMI Practicing Privileges policy required confirmation of a completed appraisal whereby
a consultant’s Responsible Officer /Clinical Director would confirm that all requirements for the
appraisal were met. Since that time an updated practicing privileges policy has been introduced
across all BMI hospitals which includes a requirement that details of completed mandatory training
are provided by all consultants on an annual basis.

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Concern 11

There was minimal documentation by the respiratory consultant with only a brief entry in the notes
on admission. There was no management plan in place, no record of any clinical examination
undertaken, and no request to check inflammatory markers which had been elevated to see
whether they had improved which may have assisted in the necessity for the chest drain. It
appeared to be an understanding a chest drain would be sited as a joint enterprise between the
physician and radiologist.

Response:

The level of documentation by both consultants was less than the standard expected and required,
which in turn, did not support ward staff in the management of the patient.

The requirement is that all management plans, interventions and clinical examinations are
documented contemporaneously (or as near to as possible) in the medical record.

In response, the following actions have been taken:

1. There have been a number of initiatives across the hospital in the last 2 years to reinforce
the standard and ensure that all consultants are aware of the requirement to make
contemporaneous notes regarding their patients.

2. Consultant input into the medical record is subject to a monthly audit on a sample basis and
audit results indicate significant improvement.

3. Consultants who do not comply with the required standard are referred to the hospital’s
Director of Nursing and the hospital’s Medical Advisory Committee (MAC) Chair and
appropriate action is taken where necessary.

| would like to assure you that we have taken the concerns identified in your report extremely
seriously and | trust the responses given above have addressed your concerns. May | also take this
opportunity to again express our sincere apologies and condolences to Mr Crittall’s family.

Yours sincerely

Executive Director

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The Royal College of Radiologists

63 LINCOLN'S INN FIELDS, LONDON WC2A 35W
7. +44(0)20 7405 1282 enquiries@rer.ac.uk
WWW. ICL aC.lk

Dr Karen Henderson

HM Assistant Coroner for Surrey
HM Coroner’s Court

Station Approach

Woking

Surrey GU22 7AP

8 July 2016

Dear Dr Henderson

Mr John CRITTALL (Deceased)
Regulation 28 Report to Prevent Future Deaths

Further to my acknowledgement letter dated 19 May, | am now in a position to respond
substantively to your Regulation 28 Report as sent a on 16 May 2016.

The Royal College of Radiologists was involved in the development of guidelines by the
British Thoracic Society BTS Pleural Disease Guideline 2010 A Quick Reference Guide
which were first published in 2010 https:/Awww. brit-thoracic.org.uk/document-library/clinical-
information/pleural-disease/pleural-disease-guidelines-2010/pleural-disease-guideline-quick-
reference-guide/ | also attach a copy of the guidelines.

In the light of your report, we are taking steps later this month to make our Fellows and
members aware once again of these important guidelines.

| trust this is a suitable response to the action you identified should be taken in your report
dated 16 May 2016.

Yours sincerely

Andrew Hall
Chief Executive
andrew_hall@rer.ac.uk

A.Chavity mgisteres wilh the Cheety Commission No, 211549
VAT Registration No. 706 9665 05