Prevention of Future Deaths reports · 2016
Regulation 28 report to prevent future deaths, reference 2016-0201, written 25 May 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 25 May 2016 |
|---|---|
| Reference | 2016-0201 |
| Deceased | Patricia Steer |
| Coroner | Jacqueline Devonish |
| Coroner area | Inner North London |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Simon Stevens, Chief Executive, NHS England P O Box 16738 Redditch B97 9PT 2. National Patient Safety Alerting System, NHS England 1 CORONER I am Jacqueline Devonish, assistant coroner, for the coroner area of Inner North London 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On 14 December 2015 commenced an investigation into the death of Patricia Steer aged 81 years. The investigation concluded at the end of the inquest on 10 May 2016. The conclusion of the inquest was that she died after the clamp was briefly left open on a central venous catheter port resulting in air embolization and cerebral infarction. CIRCUMSTANCES OF THE DEATH 4 On 1 June 2015 Mrs Steer was admitted to the Homerton Hospital for an elective right sided total knee replacement. She made a good recovery and was discharged on 8 June. On 11 June she returned to hospital unwell with sepsis, which was treated effectively using a central venous catheter. On 16 June 2015 she became unresponsive when a staff nurse left a port on the CVC (octopus) open to air as she turned away briefly during the process of flushing and changing this to a single needle connection. Mrs Steer was, up until that point, clinically well and lucid, and had been placed to sit in a chair after the morning ward round. The staff nurse attended and found her sitting in a chair when she commenced the procedure. The staff nurse knew that she should clamp the line but did not know the reasons for this. Neither did she know that undertaking this change whilst Mrs Steer was sitting up would present a risk of air emobilization. CORONER’S CONCERNS 5 During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. – (1) Neither the staff nurse who changed the catheter nor the supervising senior staff nurse who was present throughout the procedure were aware of the risk of air emobilization in the process of changing the catheter, where as it was in this case, left uncapped and unclamped. Whilst the attending Consultant was aware of the risk, the Serious Incident Investigator identified that it had not been possible to locate any literature or guidance on this point, having contacted other Trusts, and making an extensive literature search. The relevant bibliography was made available to the inquest. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you or your organisation have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 26 July 2016. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons: . I am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. 9 25 May 2016 Jacqueline Devonish
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
To Ms Devonish
Assistant Coroner
(Sent by email)
Dear Ms Devonish,
Patient Safety
NHS Improvement
Skipton House, Area 6C
80 London Road
SE1 6LH
https://www.improvement.nhs.uk
Monday 8th August 2016
Regulation 28 Report to Prevent Future Deaths following the inquest of
Patricia Steer who died on 21 June 2015
I am writing to you to respond to the concerns raised by your investigation into the
circumstances surrounding the tragic death of Patricia Steer.
For clarity, and because of the legal responsibilities attached to the organisations
that Regulation 28 letters are addressed to, I do need to briefly explain why I am
responding.
Your original Regulation letter had been addressed to Simon Stevens at NHS
England and to the National Patient Safety Alerting System, NHS England and sent
by you on 25th May 2016. I understand NHS England contacted your team to explain
that some key responsibilities related to patient safety, including delivery of the
National Patient Safety Alerting System, had shifted to another NHS body, NHS
Improvement, earlier in 2016.1
1 More detail on the transfer of functions to NHS Improvement and on the National Patient safety
Alerting System can be found here:
https://improvement.nhs.uk/uploads/documents/Patient_Safety_Alert_Stage_2_-
_Patient_Safety_transfer_to_NHS_Improvement.pdf
1
Your PA then forwarded the original Regulation 28 letter to us via email. We
contacted her to explain that it would be helpful if it could be more formally redirected
to NHS Improvement. We then received another copy of the Regulation 28 letter that
you had kindly re-dated, but where the requirement to act remained directed to the
National Patient Safety Alerting System, NHS England. We have assumed you
intended the requirement to act to prevent future deaths to be directed at the patient
safety team within NHS Improvement, and we have responded accordingly.
From your report we understand that Patricia Steer died after the clamp was briefly
left open on a central venous catheter port resulting in air embolization and cerebral
infarction.
Your main concerns were that
nursing staff were not aware of the risk of air embolization when leaving a
central venous catheter port uncapped and unclamped; and that
it had not been possible to locate any literature or guidance regarding the risk
of air entry if the clamp is left open during the use of the catheter.
The patient safety team is aware of risks associated with central lines and has
undertaken a range of work to improve safety in this area before. I have attached an
outline of this wider work as an appendix to this letter.
In relation to your specific concerns, we have been able to identify that appropriate
guidance on this risk for nurses has been established. There are two key sources:
Royal College of Nursing (2010) Standards for infusion therapy
Page 22: Under no circumstances should devices be left with caps open
or exposed.
We understand that these standards are currently being updated but we
anticipate this risk will continue to be emphasised when revised standards are
published on the RCN website.
2
Critical Care Network/ National Nurse Leads - National Competency
Framework for Adult Critical Care Nurses
Page 20 - You must be able to demonstrate through discussion essential
knowledge of (and its application to your supervised practice): Associated
hazards and complications of central venous catheters and systems
http://www.cc3n.org.uk/competency-framework/4577977310
We have discussed the issue with the Safe Anaesthesia Liaison Group (SALG),
which includes representatives from the Royal College of Anaesthetists (RCoA), the
Association of Anaesthetists of Great Britain and Ireland (AAGBI), the Medicines and
Healthcare Products Regulatory Agency (MHRA), the Faculty of Intensive Care
Medicine and the College of Operating Department Practitioners (CODP). Their
belief is that the risk is widely appreciated and is routinely covered in local training
and protocols but they accept that the findings of your inquest indicate this was not
the case in at least one organisation. These organisations have undertaken to raise
awareness amongst their members about the risk of leaving a CVC line uncapped
during use. These are the organisations best placed to take that message to the staff
which provide professional leadership, training, and supervision as well as to staff
providing direct care to patients with central lines.
We are very grateful to you for bringing your findings from your investigation of Mrs
Steer’s death to our attention and giving us the opportunity to work with others to
reduce the risk of future deaths.
Please accept my best wishes,
NHS National Director of Patient Safety
NHS Improvement
3
Appendix:
Summary of wider work to improve the safety of central lines
The key themes identified from reviews of patient safety incidents were:
Insertion related incidents (e.g. inadvertent placement into artery, perforation
of vessel causing haemorrhage, injury to the lung causing pneumothorax)
Removal related incidents (e.g. patient harm/ air embolus due to incorrect
removal technique (sitting up), disconnection/ accidental removal)
Other (e.g. central line infections, extravasation injuries, retained guide wires,
anaphylactic reaction)
Work undertaken by the patient safety team to minimise risks associated with
central lines:
General:
Central line infections - Matching Michigan Project
Intravenous Heparin Flush Solutions – Rapid response Report April 2008
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59892
Extravasation injuries - SIGNALS September 2009 and February 2010
Risk of harm from retained guidewires following central venous access |
Signal
September 2011 http://www.nrls.npsa.nhs.uk/resources/?entryid45=132829
Air embolism
Risk of air embolism when removing central lines - Signal, September 2011
http://www.nrls.npsa.nhs.uk/resources/?entryid45=132830
Nursing Times (2011) Avoiding air embolism when removing CVCs
http://www.nursingtimes.net/clinical-archive/patient-safety/avoiding-air-
embolism-when-removing-cvcs/5037174.fullarticle
Work undertaken by other national organisations to minimise risks associated with
central lines:
5
General:
NICE (2002) Guidance on the use of ultrasound locating devices for placing central
venous catheters https://www.nice.org.uk/guidance/ta49
MHRA (2013) Infusion systems
https://www.gov.uk/government/publications/infusion-systems
We understand that these standards are currently being updated but this is more
about the infusion devices themselves, rather than the clinical risks associated for
the accessories such as catheters and central lines.
Please see the main body of our reply for work with direct bearing on the issue of
caps left open and lines unclamped on central lines.
6
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