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 National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

20th December 2024

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.

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.

2

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.

3 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.

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 aŌernoon, Thank you for sending the Reg 28 report to the Department of Health and Social Care in relaƟon to the sad death of Patricia Lines. The Department has reviewed the concerns outlined in the report and, as responsibility for guidance on immunisaƟon procedures, including the "The Green Book", lies with UK Health Security Agency (UKHSA), we have determined that they are beƩer posiƟoned 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