Dear Mr Morris

Response to Regulation 28 Report to Prevent Future Deaths

I write following the conclusion of the inquest into the death of Mr Terence Grainger and in response to your Regulation 28 report dated 5th February 2025.

At the outset, may I extend my deepest sympathies and condolences to Mr Grainger’s family for their loss. I recognise that this remains an extremely challenging time for them, and I reiterate the commitment conveyed previously by my Circle Health Group (CHG) colleagues to addressing, as far as possible, all areas for improvement identified through internal and coronial review of this case. I am therefore grateful to you bringing to my attention your concerns about the absence of an electronic patient observation system featuring in CHG’s plan to introduce an electronic patient record (EPR).

In the hope that it may assist with explaining CHG’s position on this matter, I have detailed below the current regulatory requirements and the progress CHG has made to date with regards to introducing its EPR. I must however start by confirming, as a matter of important clarification, that CHG has every intention of introducing a full EPR, including expansion of an electronic patient observation system, such as those currently available in CHG’s critical care facilities, into ward-based settings. There are however a number of foundation steps that are planned ahead of this for reasons that I consider to be important, and which I have explained later in this letter.

Regulatory requirements

Use of electronic observation systems in healthcare is not currently a regulatory requirement for Care Quality Commission (CQC) registered providers such as CHG. The accurate completion of contemporaneous records and the access to those by the treating team remains a key requirement of Regulation 17 (Good Governance) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, regulated by the CQC.

CHG ensures and monitors compliance with this, and other regulatory requirements at CHG hospitals, through various mechanisms, all of which are quality assured through CHG’s governance and assurance framework. These mechanisms include:

1. Production and publication of clear and accessible policies for staƯ, agency workers and consultants, detailing the expectations and processes for record keeping at CHG hospitals. Those policies include CHG’s ‘Management of Records and Clinical Documentation’ policy and the ‘Practising Privileges’ policy. These policies supplement the national external guidance for nursing, medical and allied health professionals regarding record keeping standards, issued by the various regulatory bodies, namely the General Medical Council, Nursing and Midwifery Council and Health and Care Professions Council;

2. Development and implementation of clinical pathway documentation, including supportive tools such as checklists and observation charts. This is periodically reviewed and revised as necessary to assist the eƯective, eƯicient and accurate capturing of clinical information by clinical teams;

3. Access to record-keeping training modules via CHG’s dedicated internal learning platform, in addition to the inclusion of scenario-focussed record keeping training as part of clinical modules that form part of the CHG mandatory training programme. Further, many CHG hospitals employ practice-based educators who deliver and/or provide further support to hospitals in arranging bespoke record keeping workshops and training sessions for their clinical teams where these would be beneficial;

4. Groupwide Quality and Safety Improvement Programmes, developed through trend-analysis of incidents, complaints, patient feedback and inquests, many of which include further training on, and profile-raising of, record-keeping standards as part of wider clinical practice;

5. Contemporaneous medical record audits, completed by CHG hospitals every four months, to monitor hospital teams’ compliance with record keeping requirements, including, but not limited to, completeness and legibility of records. Any areas of concern identified by the audit processes are addressed through comprehensive action plans developed by the hospital;

6. Audit results and completion of action plans are reported via CHG’s central reporting platform and reviewed by CHG hospitals at their clinical governance committee meetings. CHG’s national clinical governance committee oversees this assurance process through its review of audit results across the group, identifying and addressing areas requiring improvement, including through escalation to board level where appropriate.

7. Clinical incidents and learning responses, which are overseen by CHG’s Patient Safety Incident Review Group, provide further opportunity to identify and appropriately address any required improvements regarding individual or team record keeping practices. This will include management via individual performance investigations and referrals to the professional regulators where appropriate.

Through these routes, I am assured that record keeping systems at CHG comply with the regulatory standards that apply across the sector in England, and support the delivery of safe, high quality patient care. Supported by its governance and assurance framework, CHG continues to ensure that compliance with the regulatory requirements is maintained.

Progress towards a full EPR

I share your view that an EPR, including an electronic system for recording patient observations, has the potential to further assist CHG’s clinical teams with contemporaneous record keeping, early identification of deteriorations and reducing the risk of record keeping errors.

As you will no doubt be aware, introduction of a fully digitised and integrated health record has been a sector-wide ambition for many years. For this reason, and as shared during the coronial proceedings, CHG has already carried out significant work towards the digitalisation and harmonisation of patient administrative and clinical electronic records across CHG. This work is the fundamental aim of CHG’s Digital Transformation Programme, led by a dedicated team accountable to CHG’s board, which commenced prior to this recent case and is ongoing.

Transition to an EPR is a complex and lengthy process, with the associated challenges being well-illustrated through reports such as those issued by the Health and Social Care Committee evaluating Government progress on its commitment to digitise the NHS and, earlier this year, by Public Policy Projects. For example, to safely and effectively implement a fully electronic system, we must ensure, that there is:

 procurement of user-friendly and fit-for-purpose patient administrative and clinical electronic record keeping systems;

 testing and assurance on the interoperability of digitalised systems to enable unimpeded access to information by clinical teams;

 procurement and roll-out of system-compatible equipment; and

 extensive engagement with staff and consultants, accompanied by a comprehensive training programme to ensure that clinical teams using the systems have the necessary digital competencies to use them.

These requirements all inherently pose complexities to be overcome. It is also fundamental that implementation of new electronic systems is approached cautiously to ensure that the desired improvements from digitisation are not negated by creating new risks to patient safety or care quality, or increasing existing ones.

Progress across the sector with the transition to an EPR is varied and CHG, like many other providers, continues to face and work through the challenges outlined above. However, and more positively, we have overcome a number of teething problems and to date have successfully introduced, across CHG, digitised systems for consent and pathology and imaging requests. We are also currently in the pilot phase for introducing an electronic pre-operative assessment system and, through CHG’s procurement process, all new equipment is designed to fully integrate with electronic patient records. While I recognise that there is work still to be done, CHG remains committed to progressing its Digital Transformation Programme as rapidly and safely as possible.

I hope that the information in this letter duly reassures you that, notwithstanding the operational challenges, CHG is actively working towards introduction of an EPR, including an electronic

record system for patient observations. Further, that pending that transition, CHG remains compliant with current regulatory record keeping requirements and will continue to monitor and ensure such compliance through its robust governance and assurance framework.