Lacey Heath

Dear Ms Hayes, Re: Regulation 28 Report to Prevent Future Deaths – Lacey Carole Anne Heath who died on 16th February 2025. Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 28th May 2026 concerning the death of Lacey Carole Anne Heath on 16th February 2025. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Ms Heath’s family and loved ones. NHS England is keen to assure the family and yourself that the concerns raised about Ms Heath’s care have been listened to and reflected upon. Your Report raises the following concerns:
1. Although Ms Heath’s experienced clinical team recommended an at home monitor be utilised to attempt to achieve a therapeutic INR range due to the complexities of her case, NICE Guidance on anticoagulation states that at home monitor is not funded by the NHS and there is no obligation for General Practitioners to fund the testing strips and incidentals required to facilitate testing. This means patients, such as Ms Heath who was on a low income, are prohibited from using this tool to attempt to achieve a therapeutic range with appropriate oral medications.
2. No application for funding was made on behalf of Ms Heath by the Trust nor was this explained to Ms Heath. There was no consideration if Ms Heath had any learning difficulties and it was noted that there was developmental delay in her medical records.
3. Ms Heath was at increased risk of developing complications with her INR results, but this was not escalated and so her clinic appointment with INR testing remained the same.
4. Hospital Medical records were not compliant with the requirements of healthcare regulators and led to a lack of appreciation of Ms Heath’s concerns, the complexity of her case and the ongoing risk to Ms Heath. Staff used an electronic platform to record INR and medication dose and have no other place to record anticoagulation records within the anticoagulation clinic. Evidence was these records are not compliant with the requirements of healthcare regulators and led to a lack of appreciation of Ms Heath’s concerns and the complexity of 6

[Page 2] her case. One entry stated Ms Heath had been “unwell” with no clarification or further information on what the problem was and/or how this may have impacted on her condition. Concern 1 and 2: Funding for home monitoring for anticoagulation Funding responsibility for at-home INR monitoring, can sit across different parts of the system depending on the clinical pathway and who held responsibility for ongoing anticoagulation management. From an anticoagulation perspective, commissioning of services is the responsibility of Integrated Care Boards (ICBs). INR machines are not prescribable on an NHS primary care prescription, and may or may not be included within routine anticoagulation service specifications. Most commonly, patients are asked to provide their own INR machine, and then the strips and other consumables are provided by the NHS on prescription via the anticoagulation service directly or via their GP. However, this will vary by ICB. This case is exceptional, however, as there was a clear clinical need for an INR home testing machine. As such an approach for funding should have been made by the anticoagulation service to the ICB for this individual, if not routinely included in the service specification. While at-home INR monitoring is not routinely commissioned, an Individual Funding Request (IFR) process exists to enable consideration of funding in cases of clinical exceptionality. In circumstances such as Ms Heath’s, an IFR application could have been submitted by the responsible specialist clinician to support access to non- routinely commissioned interventions where there is evidence of exceptional clinical need. However, no application was made in this case. We are aware you have also directed your Report to Essex ICB who will be providing a detailed response. They have, however, informed the NHS England East of England regional team that whilst they do not routinely commission at-home INR testing they are always happy to receive IFR requests for exceptional cases. Essex ICB have contacted providers to reinforce the role of the IFR process in supporting access to non-routinely commissioned interventions where standard policies do not meet the needs of clinically complex patients. They have reiterated that requests must be made prospectively by the responsible clinician, and they must ensure that patients are appropriately supported to understand available options where treatments fall outside routine commissioning. The ICB will continue to work with provider organisations to promote consistent understanding and application of the IFR process, supporting equitable access to care and reducing the risk of similar circumstances arising in future. 7

[Page 3] Concern 3: Lack of escalation We note that you have also addressed your Report to Mid & South Essex NHS Foundation Trust, who would be best placed to answer this concern as it relates to the practice of specific practitioners. Concern 4: Medical Records Non-Compliance We note that you have also addressed your Report to Mid & South Essex NHS Foundation Trust, who would be best placed to answer this concern as it relates to practice of specific practitioners. It is not clear from the Report which staff were non-compliant with keeping accurate medical records, but both the General Medical Council’s Good Medical Practice and Nursing and Midwifery Council’s Standards detail what is required of doctors and nurses when keeping contemporaneous records. 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 Ms Heath’s, 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 Hayes, Regulation 28 Report to Prevent Future Deaths – Miss Lacey Carol Anne Heath I write further to your Prevention of Future Deaths Report, dated 28 May 2026, following the conclusion of the Inquest touching on the death of Miss Heath. We have considered your concerns and now set out our formal response to each matter using your numbering as follows. Matters of Concern
1. Ms Heath was noted to be warfarin resistant and alternative medication regimes were not successful in keeping Ms Heath within a therapeutic range for her required lifelong requirement to have anticoagulation to prevent a significant risk of death. The GP and hospital clinicians trailed different combinations of appropriate therapy which included additional injections when required. This was not considered to be clinically appropriate long-term. We recognise the importance of clinically appropriate plans being in place for our patients. Therefore, we are implementing a high-risk anticoagulation pathway for patients with persistent sub-therapeutic INR, suspected warfarin resistance, complex anticoagulation requirements or repeated instability despite appropriate dose adjustment. The pathway will define criteria for senior clinical review, frequency of INR testing, escalation thresholds and documentation requirements. This is due for completion by the end of July 2026. Patients with prolonged sub-therapeutic INR or complex anticoagulation needs will be identified promptly and receive documented senior review. There will be an approved pathway, staff communication, sample audit of high-risk cases and evidence of escalation decisions recorded in the clinical record. 9

[Page 2] To maintain oversight and sustainability, the divisional governance team will undertake a monthly audit of high-risk anticoagulation cases for the first three months following implementation; thereafter there will be a quarterly audit. Any issues detected in the audits will be reported through Pathology Governance group and Broomfield Quality and Safety Hospital Group. Exception reporting at the site level feeds up directly into trust-wide board ensuring oversight at a Senior Leadership Level.
2. Due to the complexity of her case, Ms Heath’s anticoagulation was under the care of the acute hospital team. Alternative anticoagulation medication had resulted in high INR readings and significant risks associated with bleeding. By the end of August 2026, we will have conducted a complete review of the anticoagulation service escalation process for complex patients under hospital care. We plan to introduce a documented requirement for complex cases including high INR readings, bleeding risk, recurrent instability or failed alternative regimes to be reviewed by a senior clinician and, where appropriate, haematology. This will establish a clear escalation route for complex anticoagulation patients. An updated standard operating procedure will be devised to reflect this approach, which will include clearly defined senior review criteria. Communication of the new process will be undertaken will all anticoagulation staff. There will be a quarterly governance audit of complex anticoagulation cases and escalation of any compliance concerns. Any audit exceptions will be reviewed through the hospital site governance assurance groups, and appropriate actions will be assigned where documentation or escalation is incomplete or below the expected standard.
3. Ms Heath’s experienced clinical team did not consider that there had been a sufficient trial of Warfarin and recommended at-home monitoring to permit daily readings to be taken to manage the significant risks associated with anticoagulation and to find an individualised dose for Ms Heath. Clinicians were not concerned about medication non-compliance and that the difficulties were clinical. By the end of September 2026, a robust process for home INR monitoring will be in place. Prior to home monitoring proceeding, we will conduct a detailed assessment of patient suitability, any training needs, equipment requirement, general support and governance, and follow-up arrangements as necessary. This new process will ensure that decisions to recommend, decline or defer self-testing are clearly recorded with the rationale, and always discussed with the patient and, if possible, their family or carers. 10

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4. Ms Heath could not afford to fund the at home monitor as this was financially prohibitive for her being on a low income. The monitor was expensive and there is no obligation for General Practitioners to fund the testing strips and incidentals required to facilitate testing. As this would be a lifelong commitment for a woman who was only 34 years-old, Ms Heath was not able to take the advice of her expert clinical team and was compelled to have alternative prescribing that was not successful in keeping her INR within therapeutic range. By the end of September 2026 we will have a process for escalating cases where recommended anticoagulation monitoring equipment or consumables may be clinically required but financial barriers are identified. This will include signposting to available funding routes, individual funding consideration, charitable support or commissioner discussion where applicable. Where financial barriers for clinically recommended monitoring are identified, they will be escalated and documented. We plan to introduce funding and escalation guidance that will be communicated to relevant staff. To ensure the new process is working effectively, we plan to complete audits of funding applications.
5. No application for funding was made on behalf of Ms Heath by the Trust nor was this explained to Ms Heath who a very quiet, shy lady who always relied on her very loving family to assist her with appointments and could not advocate for herself. There was no consideration if Ms Heath had any learning difficulties and it was noted that there was developmental delay in her medical records. Evidence at the inquest was Ms Heath experienced this as clinicians not caring about her and she became very despondent about the failure to achieve a therapeutic range. By the end of October 2026, we plan to introduce a prompt within the high-risk anticoagulation pathway requiring clinicians to consider whether the patient may need additional communication support, family/carer involvement, reasonable adjustments or advocacy where records or presentation suggest vulnerability, developmental delay, difficulty self-advocating or reduced understanding of risk. This will ensure that patients who may have additional communication or support needs are recognised and supported in risk discussions and decision-making. This will be by way of a pathway prompt, staff briefing, audit of high-risk cases for documentation of support needs, family/carer involvement and agreed follow-up plans. The effectiveness of this prompt and pathway will be monitored by the Patient Experience and Learning Disability teams and reported to the Pathology Governance group. 11

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6. Ms Heath did not manage to achieve a therapeutic INR for a protracted period of time putting her at increased risk of developing complications and did not have a medical review or a haematology referral. A defined trigger will be set for medical review and/or haematology referral when a patient INR remains outside therapeutic range for a prolonged period; when repeated appointments are not attended during a high-risk period; or when treatment instability persists despite appropriate intervention. This will include a requirement for documented clinical rationale where referral is not made. This will allow patients with prolonged poor INR control to receive timely medical review and specialist input where indicated. The referral and escalation criteria will be updated along with a referral log, clinical record audit and governance review of any cases breaching trigger thresholds.
7. There was an absence of appropriate medical records recorded for Ms Heath to understand her clinical presentation other than very basic information on the INR platform on INR results and medication dose. Evidence was these records are not compliant with the requirements of healthcare regulators and led to a lack of appreciation of Ms Heath’s concerns and the complexity of her case. One entry stated Ms Heath had been “unwell” with no clarification or further information on what the problem was and/or how this may have impacted on her condition. We are reviewing documentation standards within the anticoagulation service, and we will implement a structured clinical note template for contacts, missed appointments, patient-reported symptoms such as “unwell”, risk discussions, escalation decisions, advice given and follow-up plan by the end of October 2026. This will explore system functionality for persistent alerts or pinned critical risk information. Clinical records will show clear evidence of the patient’s presentation, risks, advice, escalation and follow-up. Critical risk information will then remain visible to staff reviewing the case. There will be an approved note template, staff briefing, sample documentation audit and outcome of clinical system review. Monthly documentation audits will be undertaken for the first three months after implementation, followed by quarterly intervals. Results and improvement actions will be monitored through the Pathology Governance group and included in service quality reports. We are currently in the process of introducing a new single electronic patient record (‘EPR’) system across our trust. This EPR will replace/integrate with current systems services in all areas and will be for all our hospital sites. 12

[Page 5] This system will provide real-time and accurate information on a patient’s history to support clinical decision making. Clinicians will have the ability to add and access information to support quicker and personalised care for our patients, reducing the need for paper-based processes and multiple systems. The system is currently in its testing stage, expected to run through the remainder of the year. As per current timelines, the system is expected to go live in June 2027. Once established, the addition of the new EPR will be twofold:
1. The observations will be in the new EPR for all encounters across the trust from the date it goes live
2. All new electronic notes will be visible within the notes In the interim we will use our current INR monitoring system, INRstar, to conduct INR checks. Following implementation of the new EPR there will be further consideration as to its use and its suitability and combability. If I can assist any further with these matters, please do not hesitate to contact me.