Dear Ms Henley

Re: Regulation 28 Report to Prevent Future Deaths – Rachelle Naomi Ross who died on 20 April 2022.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 17 February 2023 concerning the death of Rachelle Ross on 20 April 2022. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Rachelle’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Rachelle’s care have been listened to and reflected upon.

On 1 February 2023 the functions of NHS Digital transferred to NHS England and NHS Digital ceased to exist. I apologise for the delay in our response to your Report which was sent during the transition of processes for responding to Regulation 28 reports formally addressed to NHS Digital. I realise that responses to Coroner Reports can form part of the important process of family and friends coming to terms with what has happened to their loved ones and appreciate this will have been an incredibly difficult time for them. I apologise for any anguish this delay has caused.

This response addresses the points directed to the Chief Executive of NHS Digital clarifying concerns raised about the Cervical Screening System, and its links to GP systems. HM Coroner has raised the following matters of concern with regards to this case:
1. ‘GP practice records do not include an alert from EMIS or System 1 IT systems to provide an automatic flag on a patient’s GP medical records if they are classed as a non-responder for a smear test by the National Screening Service.
2. The alert system is only triggered after a patient attends a smear test. For a non-responder, they go back into the three- or five-year waiting list for a National Screening invitation for a smear test.
3. An automatic flag or alert when a patient fails to attend for a smear test as part of the National Screening Service, would mean that a GP surgery would not have to manually add a warning as an entry onto an individual’s GP records. It would standardise the approach across all GP surgeries and could increase patient safety.’’ National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

31 August 2023

Background Cervical screening is available to women and people with a cervix aged 25 to 64 in England. People aged 25-64 years, registered with a GP as female are automatically invited through a digital call/recall process to participate in cervical cancer screening. The national programme sends the first invitation to eligible people at the age of 24.5 years. People aged 25 to 49 receive invitations every 3 years. People aged 50 to 64 receive invitations every 5 years. A reminder letter is sent at 8 weeks after the first invitation. A person is deemed a non-responder 8 weeks after the reminder letter (i.e., 16 weeks after the first invitation). When a person attends for screening their details are recorded on the Cervical Screening System. Screening results are likewise recorded on the Cervical Screening System, as is the date of the next recall (based on the findings). Further, the Cervical Screening Service produces worklists for GPs to process which includes the Prior Notification List and the Non-Responders List. Response to Coroner concerns As described above, invitations are offered for routine cervical screening every 3 years. The cervical screening system produces electronic cards for each patient who is a non-responder and these can be viewed by their GP Practice on the electronic card summary screen of the Cervical Screening System. If the person’s electronic card is not actioned - to defer or cease cervical recall - non-responders will not be contacted again by the screening agency until their next screening cycle commences (i.e., in 3 or 5 years depending on age, or sooner in the case of previous abnormal test results). GP Practices receive the results of cervical screening through laboratory integration systems. It is usual practice for these results to be filed in the GP IT software system, along with the date the next screening test is due (Due Diary). GP IT software systems typically have inbuilt alerts to notify users when a person’s cervical screening is overdue. Such alerts appear automatically in the person’s record without any further manual input, when they reach their 25th birthday. Once a person has had a cervical screening test done, the alert next appears if that person is overdue their next test. This alert stays present even if the national service has recorded the person as a non-responder and has set their recall to the next screening cycle date. These alerts appear to the user when in a patient’s records in an alert tab. This is visible in EMIS (bottom right-hand side of the screen) and in TPP (top right-hand side of the screen) along with other alerts pertinent to that person’s health status. Alerts can be removed or deactivated manually by the GP Practice but, in the case of cervical screening, their main purpose is to prompt opportunistic health promotion and engagement with cervical screening testing. Under the Quality and Outcomes Framework (QOF) scheme Cervical screening may be provided as an additional service by GP practices. In addition to tests offered, this scheme enables payment where a patient has not engaged with screening after failing to respond to the third invitation letter, based on a search facility that is set up by the GP IT System suppliers. However, exempting a person through this mechanism does not cancel the alert on their record. Further, some practices routinely invite people who are overdue their cervical screening, regardless of QOF, using their own searches or the searches set up by the GP IT Suppliers.

In this case, if Rachelle Ross lived in England, and was registered with a GP as female, she should have received two invitations from the national Cervical Screening Service when she turned 24 years 6 months, and then two further invitations every three years. This means she should have received at least six invitations through the National Cervical Screening programme prior to her death. This does not include any prompts or reminders she received from her GP. It should be noted that an alert would have been present on her GP IT records from the age of 25 years unless this was manually removed or deactivated. Screening uptake in women aged 25-45 years has been declining over the past 10 years at a greater rate than other age groups. Jo’s Cancer Trust has carried out research on why people are not taking advantage of cervical screening, with common reasons for non-engagement including embarrassment, pain, fear of results, and a lack of understanding (including myths around cervical screening especially prevalent on social media). I would like to provide further assurances on 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 preventable deaths are shared across the NHS at both a national and regional level and helps us 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 Miss Henley

Re: Rachelle Naomi ROSS

Thank you for your letter of 21st February 2023. This is a very sad situation.

I am a GP by background ( and was the first user of SystmOne (the product supplied by TPP) in 1999. I have been the clinical director of TPP for 18 years.

SystmOne has a built in report in support of the Quality Outcomes Framework that alerts GPs on the home screen (the screen that is first seen when a patient record is opened) when a patient is due a cervical smear. This is not dependent on the patient having had a cervical smear. The list of patients who are requiring a smear are also available in the reporting system as a list of patients ready for letters / reminders / SMS messages to be sent as the practice decides.

With regard to your specific point about an alert when a patient has not responded to an invitation by the National Screening Service – my understanding is that GPs are not informed of this, and there is no mechanism for this information to be sent directly into the electronic patient record. As a result that computer cannot alert the GP as it does not hold this information.

In summary – there is an automatic alert within the system when a patient is due a smear, irrespective of whether they have had one or not.

I firmly believe that information from all the NHS adult screening services should be sent automatically to the GP IT systems. Currently only the bowel screening service is sent in this way. All other screening services are sent via a paper note that may or may not be entered into the patient way in such a manner that can be computed. I would support any action you recommend to enhance the flow of information to the GP systems from the national screening services.

Dear Miss Henley,

We write in response to the Regulation 28 report dated 21st February 2023 (the “Report”). Firstly, we were saddened to read of the death of Ms Ross and would like to take this opportunity to express our sincere condolences to their family. As a company, we work very hard to support health care services across the UK and patient safety is of paramount importance to us. We have reviewed and considered your concerns raised in the Report and have undertaken an internal review.

As stated in the Report, the patient first became eligible for invitation for cervical screening via the National Screening Programme, in 2012, at the age of 25. EMIS Web was the Electronic Patient Record system (“the System”) used by Ms Ross’s GP surgery (as part of the Collingwood Health Group) until 2017, when they migrated to another Electronic Patient Record system. Your first concern was in relation to evidence provided during the coroner’s inquest by a GP Partner from the Collingwood Health Group, namely that the System does not provide an automatic flag, or alert, on a patient’s medical record if they are classed as a non-responder to an invitation for a National Screening Programme event, such as cervical screening (“Cervical Screening Event”). However, we feel it important to note that in the case of a patient failing to respond to an invitation for a Cervical Screening Event, an automatic alert (triggered by the absence of a code indicating completion of Cervical Screening Event), which reads “Cervical Smear due or outstanding”, will display each time the patient’s record is opened in the System. This alert is triggered regardless of whether the patient has historically attended for a Cervical Screening Event or not (in accordance with the NHS Cervical Screening Programme). The alert remains visible on the patient record until the patient is recalled by the National Screening Programme in 3 or 5 years depending on age. A clinical user may choose to suppress alerts during a clinical session; however this automatically reverts to the default of ‘visible’ when they next log in to the System as alerts cannot be turned off at a Practice level. In addition to the automatic alert described above, any GP practice using the System has the ability to extract a list of patients who remain eligible, but are not up to date, with their cervical screening. This can be undertaken by accessing the ‘Population excluded’ file from the QOF reporting screen (part of the Population Reporting module). It is possible to exclude patients from cervical screening recalls (and therefore this list), but should only be after an informed discussion between the patient and a

clinician which is documented on a disclaimer letter (known as informed consent for withdrawal from the Cervical Screening Programme). EMIS Web has included QOF alerts since before this patient would have been eligible for her first cervical smear in 2012. We can confirm that all of the functionality described above meets the specification provided by NHS Digital (now, NHS England). Conclusion At EMIS we are proponents of continuous improvement, and we will continue to review our solutions to determine whether there are changes to be made which would improve their performance. In this instance, we believe that the System already meets required specifications as well as your recommendation of including an automatic flag/alert when a patient fails to attend for cervical screening as part of the National Screening Programme. EMIS will continue to review and investigate any cases of a similar nature, and review effectiveness of any current and ongoing mitigations. We trust that the details outlined above are of help. If you have any further queries then please contact our Senior Clinical Director,

, in the first instance. Kind regards

Chief Medical officer, EMIS Group

Dear Ms Henley,

Thank you for the Regulation 28 report to prevent future deaths of 17 February 2023 about the sad death of Ms Rachelle Ross. I am replying as Minister with responsibility for health and secondary care.

Firstly, I would like to say how saddened I was to read of the circumstances of Ms Ross’ death and I offer my sincere condolences to their family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention. Please accept my sincere apologies for the significant delay in responding to this matter. I would like to assure you that the department is mindful of the statutory responsibilities in relation to prevention of future deaths reports and we take every case extremely seriously.

The report raises concerns over patient records systems used in GP services and how alerts operate for non-responders for a smear test.

In preparing this response, Departmental officials have made enquiries with NHS England and the Care Quality Commission (CQC). I am also aware of the published responses provided by the GP surgery, the system provider and NHS England.

Professor Steven Powis in his capacity as the National Medical Director of NHS England has responded in detail to the concerns you have raised. I do hope that, as an executive non-departmental public body, sponsored by the Department of Health and Social Care, the response provided by NHS England has addressed your concern. I would also add that, NHS England is also in the process of creating a new IT Cervical Screening Management System (CSMS), which is due to go live in Quarter 1 2024/25. This system will enable general practice users to review a list of

their non-responders for their individual GP practice. This function will provide practices with the ability to identify and proactively remind and/or invite their non attending eligible patients to take up the offer of a cervical sample taking appointment.

In our discussions with CQC, they agree that the concerns raised by the coroner have highlighted an important area. Although CQC does not have statutory powers in relation to clinical system providers they will consider engaging with them to enquire and encourage an improvement in this area.

I hope this response is helpful and further reassures you of the work being undertaken in this vital area. Thank you for bringing these concerns to my attention.

Kind regards,

THE RT HON ANDREW STEPHENSON CBE MP MINISTER OF STATE