Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0574, written 24 Oct 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 24 Oct 2024 |
|---|---|
| Reference | 2024-0574 |
| Deceased | Patricia Lines |
| Coroner | Rebecca Sutton |
| Coroner area | Durham and Darlington |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 4 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. UK Health Security Agency 2. Department of Health and Social Care 3. NHS England 1 CORONER I am Rebecca Sutton, assistant coroner, for the coroner area of County Durham and Darlington 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 6 November 2023 an investigation into the death of Patricia Heather Lines, aged 77, was commenced. The investigation concluded at the end of the inquest before a jury on 22 October 2024. The medical cause of death was: I a Septicaemic Shock I b Necrotising Fasciitis, Right Shoulder I c Invasive Group A Streptococcus Pyogenes Infection II Type 2 Diabetes Mellitus; Ischaemic, Hypertensive and Valvular Heart Disease The conclusion of the jury was “Accident”. 4 CIRCUMSTANCES OF THE DEATH The deceased underwent an intramuscular Vitamin B12 injection into her right shoulder on 17 October 2023. The following day she became unwell and was admitted to hospital. Blood tests revealed that the deceased was suffering with an Invasive Group A Streptococcus Infection. Despite receiving hospital treatment, the deceased’s condition deteriorated and she died on the 23rd October 2023. The post mortem pathology evidence indicated that the most likely source of the Invasive Group A Streptococcus Infection was the intramuscular injection; it was likely that streptococcus bacteria was present on the skin of the shoulder at the time of the injection and it was introduced into the deeper tissues of the shoulder when the injection was administered. 5 CORONER’S CONCERNS 1 During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: The nurse who administered the injection gave evidence that she did not clean the skin prior to administering the injection. She did not do so because she was following both her training (she quoted from an NHS e-learning module on administering intramuscular injections) and national guidance in the form of a document titled “Immunisation Against Infectious Disease”, which is also referred to as “The Green Book”. Chapter 4 of “The Green Book” provides guidance on immunisation procedures. In relation to cleaning the skin the Green Book states as follows (at page 29): If the skin is clean, no further cleaning is necessary. Only visibly dirty skin needs to be washed with soap and water. It is not necessary to disinfect the skin. Studies have shown that cleaning the skin with isopropyl alcohol reduces the bacterial count, but there is evidence that disinfecting makes no difference to the incidence of bacterial complications of injections (Del Mar et al., 2001; Sutton et al., 1999). The evidence that I heard at the inquest included that alcohol wipes are relatively cheap and their use does not give rise to any significant risk. I note that the Green Book states that cleaning the skin with alcohol reduces the bacterial count. Common sense would seem to suggest that reducing the bacterial count would reduce the risk of bacteria being inadvertently introduced into the deeper tissues during an injection. Whilst it is noted that the Green Book also makes reference to there being evidence that disinfecting makes no difference to the incidence of bacterial complications, it is also noted that the literature quoted is now over 20 years old. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe your organisation has 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 20 December 2024. 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 Person, . I have also sent it to the GP surgery where the injection was administered, who may find it useful or of interest. 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 2 your response, about the release or the publication of your response by the Chief Coroner. 9 24 October 2024 Rebecca Sutton HMAC County Durham and Darlington 3
4 responses 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.
Browney House Surgery Front Street Langley Park County Durham DH7 9YT Tel: 0191 373 2860 Fax: 0191 373 0685 Branch Surgery: Croft View Surgery 3 Croft View Lanchester County Durham DH7 OHY Tel/Fax: 01207 521906 16.12.2024 Dear Rebecca Sutton, HMAC County Durham & Darlington, Re: Regulation 20 Report to Prevent Future Deaths. Thank you for sending me the investigation report into the accidental death of Mrs. Patricia Lines, aged 77. I can confirm that this report has been discussed in Practice with both Clinicians and Management staff. The Practice will take the following actions in order to prevent similar cases from occurring. This case will be used as a learning exercise in Clinical staff appraisals. It is important that the outcome of this case can be used positively to prevent such cases from happening again. Staff will continue to attend Infection Prevention and Control courses annually or sooner if required. Clinical staff will enroll into an Injection Administration Training course to improve practical competency in injection administration. Staff will follow local and national up to date guidance for (a) the administration of injections to patients and (b) skin preparation at the site of the injection before administration. The Practice feels that the above actions can have a positive impact for both Clinical staff and Patients, preventing cases like this one from happening again. Kindr ards
Received from Department of Health and Social Care 27/11/24 PFD response Good a(cid:332)ernoon, Thank you for sending the Reg 28 report to the Department of Health and Social Care in rela(cid:415)on to the sad death of Patricia Lines. The Department has reviewed the concerns outlined in the report and, as responsibility for guidance on immunisa(cid:415)on procedures, including the "The Green Book", lies with UK Health Security Agency (UKHSA), we have determined that they are be(cid:425)er posi(cid:415)oned to address these issues. Since UKHSA are also a named recipient in the report, we have engaged with them, and they have confirmed receipt of the report and are working on their response. Kind regards, DHSC PFD Oversight Team Quarry House, Quarry Hill, Leeds, LS2 7UE
Ms Rebecca Sutton
Assistant Coroner
County Durham and Darlington Coroner’s Service
Crook Coroners Court
North Terrace
Civic Centre
Crook
DL15 9ES
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
20th December 2024
Dear Coroner,
Re: Regulation 28 Report to Prevent Future Deaths – Patricia Heather Lines
who died on 23 October 2023
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 24
October 2024 concerning the death of Patricia Heather Lines on 23 October 2023. In
advance of responding to the specific concerns raised in your Report, I would like to
express my deep condolences to Patricia’s family and loved ones. NHS England are
keen to assure the family and the Coroner that the concerns raised about Patricia’s
care have been listened to and reflected upon.
Your Report raises the concern that both an NHS e-learning module on administering
intramuscular injections and Chapter 4 of “The Green Book” do not advise to wash,
wipe or disinfect skin that already appears clean at the site of and prior to
immunisation. You also raised that the relevant section of “The Green Book” is now
over 20 years old.
My response to your Report has been informed by the Infection Prevention team here
at NHS England. Our own Infection Prevention and Control (IPC) guidance aligns with
‘The Green Book’ (UKHSA guidance, published on 11 September 2013), which serves
as the national standard for vaccination and immunisation by injection. As you have
noted in your Report, Chapter 4 of The Green Book indicates that skin preparation is
unnecessary if the skin is clean and not visibly dirty. It is the responsibility of the UK
Health Security Agency (UKHSA) to confirm that ‘The Green Book’ remains current
and to update it when required. In addition, local policies should inform practice in
specific cases (e.g. immunocompromised patients). NHS England will review the
contents of UKHSA’s response once this has been received
As part of our review into this case, we have identified additional sources of published
guidance, some of which provide conflicting advice on the practice of cleaning a
patient’s skin prior to immunisation. However, the maintenance and updating of such
guidance falls outside of NHS England’s remit. Some examples include:
• The Royal Marsden manual of Clinical and Cancer Nursing Procedures
(Medication: intramuscular injection - Royal Marsden Manual), which states:
“Clean the injection site with a swab saturated with isopropyl alcohol 70% for
30 seconds and allow to dry for 30 seconds. To reduce the number of
pathogens introduced into the skin by the needle at the time of insertion and
to prevent a stinging sensation if the alcohol is taken into the tissues upon
needle entry.”
• WHO guidelines (2010, p.7) recommend skin cleaning before injections,
although these are global standards and are not specific to the UK.
In Patricia’s case, it is entirely possible that this was an isolated incident, although it is
difficult to comment on this without further information. The infection may have been
due to factors such as commensal bacteria or external contamination, rather than a
failure to clean the skin prior to injection. It is essential that healthcare practitioners
administering intramuscular injections receive appropriate training to ensure they are
proficient in best practices, including hand hygiene and infection prevention protocols.
I would also like to provide further assurances on the national NHS England work
taking place around the Reports to Prevent Future Deaths. All reports received are
discussed by the Regulation 28 Working Group, comprising Regional Medical
Directors, and other clinical and quality colleagues from across the regions. This
ensures that key learnings and insights around events, such as the sad death of
Patricia, are shared across the NHS at both a national and regional level and helps us
to pay close attention to any emerging trends that may require further review and
action.
Thank you for bringing these important patient safety issues to my attention and please
do not hesitate to contact me should you need any further information.
Yours sincerely,
National Medical Director
UKHSA North East
Health Protection Team
1st Floor, Newcastle Civic Centre,
Barras Bridge,
Newcastle upon Tyne
NE1 8QH
T: +44 (0)300 303 8596
Ms Rebecca Sutton
Assistant Coroner
Co. Durham and Darlington
Crook Civic Centre
Co. Durham
DL15 9ES
26 November 2024
Dear Ms Sutton
Re: Ref: 2024-0574, Regulation 28 report to prevent future deaths
Thank you for the prevention of future deaths report received by the UK Health Security
Agency (UKHSA) on 25 October 2024.
UKHSA would like to start this response by expressing our deepest sympathies to the family
of Patricia Lines.
The concerns raised in the report have been considered and reflected upon by UKHSA and
its response is below.
Invasive Group A Streptococcus
Invasive group A streptococcus (iGAS) infection was introduced as a statutorily notifiable
infectious disease in England and Wales in 2010 to enable public health actions to prevent
and control the spread of infection through (a) the establishment of any potential sources of
infection and (b) the establishment of any settings or contexts that may require a more
detailed risk assessment to establish close contact and take action to limit possible onward
transmission.
Notification and UKHSA health protection investigation/action
UKHSA’s North East health protection team (HPT) was notified that Mrs Lines had iGAS on
20 October 2023, on the basis of a specimen taken on 18 October 2023. In line with UKHSA
guidance, the HPT undertook contact tracing to identify vulnerable and symptomatic contacts
of the case and establish their requirement for antibiotic treatment or chemoprophylaxis.
1
Vitamin B12 intramuscular injection
Prior to the receipt of the prevention of future deaths report, the HPT was not aware that Mrs
Lines had received an intramuscular injection prior to the onset of her symptoms. However,
as the risk of infection following intramuscular injection is a rare but recognised complication
of the procedure and given that no other linked case of infection had been reported,
knowledge of this series of events would have been unlikely to alter the course of our
investigation.
Your report highlighted that, when questioned at the inquest, the nurse who administered the
intramuscular injection cited guidance from the ‘Green Book’ regarding the requirement for
the use of alcohol wipes prior to vaccination as well as an NHS e-learning module.
Immunisation against infectious disease: the Green Book
The ‘Green Book’ (officially entitled ‘Immunisation against infectious disease’) is a UKHSA
publication (having previously been produced by Public Health England). It is the main
authoritative resource for healthcare professionals involved in the delivery of immunisation
programmes across the UK. The last printed version of the book was published in 2006;
since then it has been published online. The publication contains two parts. Part 1 covers
principles, practices, and procedures in relation to vaccination. Part 2 contains individual
chapters in relation to vaccinations and vaccines for specific diseases.
Response to concerns raised in the prevention of future deaths report
The ‘Green Book’ advises that, prior to administration of vaccinations, only visibly dirty skin
needs to be washed with soap and water and it is not necessary to disinfect the skin. This is
because studies have shown that cleaning the skin with isopropyl alcohol reduces the
bacterial count, but there is evidence that disinfecting makes no difference to the incidence
of bacterial complications of injections.
Furthermore, alcohol wipes may increase injection site reactions as alcohol may track
intramuscularly, subcutaneously, or intradermally following vaccination. In addition, the use
of alcohol wipes is not recommended prior to the administration of vaccines due to the
theoretical risk of the alcohol deactivating a live vaccine. There is a lack of international
consensus on the use of alcohol wipes prior to vaccination but the Green Book guidance
aligns with the advice on vaccinations contained within the World Health Organization’s Best
Practices for Injections and Related Procedures Toolkit.
Although infection is a known risk associated with intramuscular injections, infections
following administration of vaccinations remain rare. The ‘Green Book’ provides specific and
clear guidance on the administration of vaccinations and should not be interpreted as a
general guide for delivering all intramuscular injections.
2
This is because the risks associated with other intramuscular injections may vary according
to the specific product being used, including the nature and volume of the substance to be
injected, the manner of its preparation, and the characteristics of the needle used to perform
the injection. The manufacturer’s guidance contained within the product information may be
a source of information for the delivery of intramuscular injections that are not vaccinations.
UKHSA is unable to comment on the appropriateness of using alcohol wipes before
administering Vitamin B12 injections, as this falls outside of its remit.
Given the above information, and following discussions within UKHSA involving both the
Specialist Vaccines team and the Infection Prevention and Control team, UKHSA has no
plan to amend the ‘Green Book’ guidance in relation to the use of alcohol wipes prior to the
administration of vaccinations.
Thank you for bringing this matter to our attention.
Yours sincerely,
Regional Deputy Director for Health Protection, North East
UK Health Security Agency
3
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