Document Control & Equality Statement

Distribution

This policy applies throughout Direct Medicare Ltd and shall be made available to all employees, contractors, clinicians, visiting healthcare professionals and relevant external stakeholders where appropriate.

Controlled copies shall be maintained electronically within the Clinical Governance Document Library. Printed copies are considered uncontrolled unless specifically authorised.

Equality Statement

Direct Medicare Ltd is committed to promoting equality, diversity and inclusion throughout its services. Implementation of this policy will ensure that all patient safety incidents are managed fairly, transparently and without discrimination based upon age, disability, sex, gender reassignment, race, religion or belief, sexual orientation, pregnancy or maternity, marriage or civil partnership, or socio-economic background.

1. Introduction

Direct Medicare Ltd is committed to delivering safe, effective, patient-centred healthcare across all diagnostic ultrasound services.

Patient safety is fundamental to high-quality healthcare and is central to the organisation’s clinical governance arrangements. Whilst every effort is made to minimise risk, the organisation recognises that patient safety incidents may occur despite appropriate systems and professional practice.

Direct Medicare Ltd is committed to fostering an open, transparent and learning culture in which staff feel supported to report incidents, identify hazards and contribute to continual improvement without fear of inappropriate blame.

This policy establishes the organisational framework for identifying, reporting, responding to and learning from patient safety incidents. It is based upon the principles of proportionality, openness, continuous improvement and patient involvement.

The organisation recognises that understanding why incidents occur is significantly more valuable than assigning blame. Learning gained from patient safety incidents will therefore be used to strengthen systems, improve clinical practice and reduce future risks.

2. Purpose

The purpose of this policy is to establish a consistent framework for the management of patient safety incidents across Direct Medicare Ltd. Specifically, this policy aims to:

• Promote a proactive patient safety culture.
• Encourage timely reporting of patient safety incidents and near misses.
• Ensure immediate action is taken to protect patients following an incident.
• Support patients, families and staff affected by patient safety incidents.
• Ensure compliance with statutory Duty of Candour requirements.
• Facilitate proportionate learning responses.
• Identify opportunities for quality improvement.
• Reduce recurrence of avoidable incidents.
• Promote organisational learning.
• Demonstrate compliance with contractual, regulatory and clinical governance obligations.

3. Scope

This policy applies to all services delivered by Direct Medicare Ltd including, but not limited to:

• General Diagnostic Ultrasound.
• Musculoskeletal Ultrasound.
• Community Diagnostic Services.
• NHS Commissioned Services.
• Private Self-Pay Services.
• Corporate Healthcare Services.
• Future Ultrasound-Guided Musculoskeletal Injection Services.

This policy applies to every individual working on behalf of Direct Medicare Ltd, including Consultant Radiologists, Sonographers, Reporting Clinicians, Medical Practitioners, Visiting Healthcare Professionals, Administrative Staff, Reception Staff, Managers, Directors, Agency Staff, Contractors, and Students undertaking supervised clinical placements. All staff are required to comply with this policy.

4. Policy Statement

Direct Medicare Ltd is committed to providing healthcare services that are safe, effective and centred on the needs of patients. The organisation believes that improving patient safety requires openness, honesty, professional accountability and continuous organisational learning.

Patient safety incidents will be managed using a proportionate, systems-based approach that seeks to understand the underlying factors contributing to incidents rather than focusing solely upon individual actions.

The organisation is committed to developing a Just Culture in which staff are encouraged to report incidents, concerns and near misses without fear of unfair criticism, whilst recognising that professional accountability remains essential. Learning identified from patient safety incidents shall be shared throughout the organisation and used to improve clinical practice, reduce risk and enhance patient outcomes.

5. Strategic Objectives

Direct Medicare Ltd aims to:

• Deliver safe diagnostic healthcare.
• Protect patients from avoidable harm.
• Maintain public confidence.
• Promote openness and transparency.
• Support clinicians involved in incidents.
• Encourage reporting of patient safety concerns.
• Learn from every significant incident.
• Improve systems of work and reduce clinical risk.
• Promote continuous quality improvement.
• Meet the expectations of commissioners and the Care Quality Commission.
• Strengthen organisational governance.

6. Guiding Principles

7. Governance Structure

Patient safety governance within Direct Medicare Ltd is embedded within the organisation’s Clinical Governance Framework and is overseen through a clear reporting structure designed to ensure accountability, transparency, and continuous improvement.

Ultimate responsibility for patient safety rests with the Managing Director, who delegates day-to-day clinical governance responsibilities to the Clinical Governance Lead and Clinical Director. The governance structure shall comprise:

Managing Director

Overall organisational accountability, ensures adequate resources are available to support patient safety, receives assurance through governance reports, and approves strategic patient safety improvements.

Clinical Director (Consultant Radiologist)

Provides independent clinical leadership and oversight, advises on complex patient safety incidents, supports clinical policy development, reviews serious clinical events where appropriate, and oversees clinical standards.

Clinical Governance Lead

Leads implementation of this policy, maintains the patient safety management system, coordinates learning responses, maintains the incident register, reports trends to the Clinical Governance Committee, and ensures actions are completed.

Lead Sonographers

Promote safe clinical practice, ensure incidents are reported promptly, support staff following incidents, and participate in investigations and learning reviews.

All Clinical Staff

Deliver safe patient care, report incidents immediately, participate openly in investigations, and implement learning recommendations.

Administrative Staff

Escalate administrative incidents affecting patient safety, maintain confidentiality, and support documentation and communication processes.

8. Clinical Governance Committee

The Clinical Governance Committee is responsible for overseeing the implementation of the Patient Safety Incident Response Framework. The Committee shall normally meet quarterly and additionally where significant patient safety issues require urgent review.

Membership should include the Managing Director (Chair), Clinical Director, Clinical Governance Lead, Lead Sonographer, Operations Manager, and Quality Representative (where appointed).

The Committee shall review incident trends, review complaints relating to patient safety, monitor implementation of learning actions, review clinical audit outcomes, review risk registers, approve patient safety improvement actions, monitor compliance with this policy, and recommend policy amendments. Minutes of meetings shall be retained within the Clinical Governance document management system.

9. Definitions

Patient Safety Incident

An unintended or unexpected event that could have, or did, result in harm to a patient receiving healthcare. Examples include incorrect patient identification, delayed diagnosis, incorrect ultrasound report, missed significant pathology, equipment malfunction, infection control breach, communication failure, medication error (where applicable), and incorrect referral pathway.

Near Miss

An event that had the potential to cause harm but did not reach the patient or resulted in no harm due to timely intervention. Near misses provide valuable learning opportunities and should always be reported.

Harm

Physical, psychological or emotional injury resulting from healthcare. Harm may be categorised as No Harm, Low Harm, Moderate Harm, Severe Harm, or Death.

Learning Response

A structured review undertaken following a patient safety incident with the primary objective of understanding why the incident occurred and identifying opportunities for improvement.

Just Culture

A workplace culture that encourages openness, fairness and learning whilst recognising individual accountability for professional conduct.

10. Patient Safety Culture

Direct Medicare Ltd is committed to developing and maintaining a positive patient safety culture. The organisation recognises that most patient safety incidents arise from weaknesses within systems rather than individual failings. Accordingly, the organisation encourages honest reporting, early escalation, shared learning, constructive feedback, continuous quality improvement, and respectful communication.

11. Identification of Patient Safety Incidents

Patient safety incidents may be identified through staff reports, patient complaints, clinical audit, peer review, image review, reporting discrepancies, equipment failures, infection control incidents, safeguarding concerns, data breaches affecting clinical care, and external notifications. Every member of staff has a responsibility to identify and report concerns.

12. Reporting Patient Safety Incidents

All incidents shall be reported as soon as reasonably practicable. Immediate reporting enables prompt clinical review, reduction of further risk, accurate collection of evidence, early patient communication, and organisational learning.

Incident reports should include date and time, location, individuals involved, description of the incident, immediate actions taken, actual or potential harm, witnesses, and supporting documentation.

The Clinical Governance Lead shall maintain a confidential Patient Safety Incident Register.

13. Immediate Response to an Incident

The priority following any patient safety incident is the safety and wellbeing of the patient. The clinician involved shall ensure immediate clinical care is provided, assess ongoing patient risk, arrange urgent referral where required, inform an appropriate senior clinician, preserve relevant evidence, record the event accurately, notify the Clinical Governance Lead, and commence Duty of Candour procedures where applicable.

14. Incident Classification

Patient safety incidents shall be assessed according to:

Clinical Severity

No Harm, Low Harm, Moderate Harm, Severe Harm, Death.

Patient Impact

Physical, Psychological, Emotional.

Organisational Risk

Low, Medium, High, Extreme.

The classification determines the proportionate learning response.

15. Risk Assessment

Following notification, every incident shall undergo an initial risk assessment considering actual harm, potential harm, likelihood of recurrence, complexity, public confidence, regulatory implications, and learning potential. The Clinical Governance Lead may seek advice from the Clinical Director where specialist clinical review is required.

16. Principles of PSIRF Learning Responses

Direct Medicare Ltd adopts a proportionate approach to learning. Not every incident requires a lengthy investigation. Instead, learning responses should match the severity of the incident, the complexity of the contributing factors, the potential for organisational learning, and the opportunity to improve patient safety.

Possible learning responses include immediate local review, structured case discussion, After Action Review, multidisciplinary learning review, thematic review of recurring incidents, and formal Patient Safety Incident Investigation (where justified).

Every learning response aims to understand what happened, why it happened, and what improvements can reasonably be made to reduce the likelihood of recurrence.

17. Duty of Candour

17.1 Commitment

Direct Medicare Ltd is committed to fostering an organisational culture characterised by openness, honesty and transparency. Where a patient safety incident has resulted in, or has the potential to result in, moderate harm, severe harm or death, the organisation shall comply with the statutory Duty of Candour in accordance with Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

The purpose of the Duty of Candour is to ensure that patients and, where appropriate, their families are informed promptly, treated with compassion, offered a sincere apology, and kept informed throughout the review process. An apology is not an admission of liability but an acknowledgement that the patient’s experience and wellbeing are important.

17.2 Duty of Candour Procedure

Where the statutory Duty of Candour applies, the responsible clinician or nominated senior manager shall ensure that:

• The patient receives immediate and appropriate clinical care.
• The incident is explained honestly using language the patient can understand.
• A sincere verbal apology is offered.
• The patient is informed of the immediate actions taken to ensure their safety.
• The patient is advised that the incident will be reviewed.
• The patient is given an opportunity to ask questions.
• A written summary and apology are provided where required.
• All discussions are documented in the patient’s clinical record.
• Ongoing communication is maintained until the review is complete.

Patients shall be offered appropriate support throughout this process.

18. Patient and Family Engagement

Direct Medicare Ltd recognises that patients, carers and family members often provide valuable insight into patient safety incidents. Where appropriate, patients shall be invited to contribute to the learning response by providing their account of events, identifying concerns, suggesting improvements, reviewing factual accuracy, and receiving feedback regarding organisational learning.

Patient involvement shall be proportionate to the nature and complexity of the incident. All communication shall remain respectful, compassionate and confidential.

19. Learning Responses

The purpose of every learning response is to understand the factors that contributed to an incident and identify practical improvements that reduce the likelihood of recurrence. Learning responses are not disciplinary investigations. The organisation shall select the most appropriate learning response according to the severity, complexity and learning potential of the incident.

19.1 Immediate Local Review

Used where minimal or no harm occurred, learning is straightforward, and local corrective action is sufficient.

19.2 After Action Review

An After-Action Review is a structured discussion held shortly after an event. The review should consider what was expected to happen, what actually happened, why there were differences, and what can be improved. This approach promotes rapid learning and immediate service improvement.

19.3 Multidisciplinary Learning Review

Complex incidents involving multiple staff groups may require a structured multidisciplinary review, with participants that may include sonographers, the Consultant Radiologist, the Clinical Governance Lead, administrative representatives, and relevant managers. The objective is to identify contributory factors rather than assign blame.

19.4 Thematic Review

Where similar incidents occur repeatedly, Direct Medicare Ltd may undertake a thematic review to identify common underlying system weaknesses — for example, recurrent referral errors, repeated image labelling mistakes, frequent appointment failures, reporting discrepancies, or communication failures. Recommendations shall address organisational rather than individual factors wherever possible.

19.5 Formal Patient Safety Incident Investigation

A formal investigation may be commissioned where significant patient harm has occurred, there is substantial learning potential, commissioners or regulatory bodies request investigation, or senior management determines that detailed investigation is necessary. Formal investigations shall remain objective, use recognised investigation methodology, involve appropriate clinical expertise, and produce clear recommendations.

20. Contributory Factors

When reviewing incidents, investigators should consider multiple contributing factors rather than focusing solely upon individual actions. These may include:

Patient Factors

Clinical complexity, communication needs, co-morbidities, language barriers.

Human Factors

Fatigue, workload, distractions, experience, competency.

Equipment Factors

Equipment failure, software malfunction, maintenance issues, image quality.

Environmental Factors

Clinic layout, lighting, noise, infection control.

Organisational Factors

Policies, staffing, communication systems, training, resources.

Understanding these factors enables meaningful organisational learning.

21. Action Plans

Every learning response shall produce a documented action plan where improvements are identified. Action plans should include the improvement objective, required action, responsible individual, target completion date, progress status, and evidence of completion. Actions shall be proportionate, realistic and measurable. The Clinical Governance Lead shall monitor implementation and report progress to the Clinical Governance Committee.

22. Monitoring of Improvements

Implementation of recommendations shall be monitored through clinical audit, image quality review, peer review, incident trend analysis, patient complaints, patient feedback, staff feedback, and governance meetings. Recommendations shall remain open until satisfactory evidence demonstrates completion.

23. Organisational Learning

Learning identified from patient safety incidents shall be shared throughout the organisation using appropriate communication methods, including clinical governance meetings, safety briefings, team meetings, staff newsletters, clinical education sessions, mandatory training, updated policies, standard operating procedures, and clinical audits.

Where learning has wider relevance, Direct Medicare Ltd may also share anonymised learning with commissioners, partner organisations or professional networks where appropriate.

24. Staff Support

Direct Medicare Ltd recognises that patient safety incidents may affect healthcare professionals involved in an incident. Managers shall ensure that staff receive appropriate support following significant incidents, which may include clinical supervision, reflective practice, debriefing, Occupational Health referral where appropriate, additional training, and mentorship.

Supporting staff contributes to patient safety by promoting resilience, openness and continuous professional development.

25. Records Management

All documentation relating to patient safety incidents shall be accurate, contemporaneous, factual, confidential, and securely retained in accordance with the organisation’s Records Management Policy and applicable data protection legislation. Access shall be restricted to authorised personnel with a legitimate need to know.

26. Education, Training and Competency

26.1 Training Commitment

Direct Medicare Ltd recognises that maintaining a safe healthcare environment depends upon a competent and knowledgeable workforce. The organisation is committed to ensuring that all staff receive appropriate education and training in patient safety principles, incident reporting, Duty of Candour, and the Patient Safety Incident Response Framework (PSIRF). Training shall be proportionate to an individual’s role and responsibilities.

26.2 Induction

All newly appointed employees, contractors and clinical staff shall receive induction covering Clinical Governance arrangements, patient safety culture, incident reporting procedures, Duty of Candour, safeguarding responsibilities, Information Governance, escalation procedures, risk management, and the complaints process. Staff shall not work unsupervised until essential induction requirements have been completed.

26.3 Mandatory Training

The following subjects shall be included within the mandatory training programme where relevant to staff roles: Patient Safety Incident Reporting, Duty of Candour, Safeguarding Adults, Safeguarding Children, Infection Prevention and Control, Information Governance, Basic Life Support, Fire Safety, Equality Diversity and Inclusion, Mental Capacity Act, Prevent Awareness, Lone Working, and Clinical Documentation. Training compliance shall be monitored through the organisational training matrix.

26.4 Continuing Professional Development

Registered healthcare professionals are expected to maintain professional competence through continuing professional development (CPD) in accordance with the requirements of their professional regulator. Direct Medicare Ltd will support staff participation in clinical audit, peer review, case discussions, reflective practice, external education, professional conferences, and ultrasound quality assurance activities.

27. Clinical Audit and Quality Assurance

Clinical audit is a key component of the Patient Safety Incident Response Framework. Audit enables Direct Medicare Ltd to determine whether patient safety improvements have been effectively implemented and sustained.

Annual audit programmes should include, where appropriate: incident reporting compliance, image quality audit, report accuracy audit, peer review, referral appropriateness, waiting times, Duty of Candour compliance, complaints analysis, patient satisfaction, equipment quality assurance, and infection prevention compliance. Audit findings shall be reported to the Clinical Governance Committee.

28. Monitoring Compliance

Compliance with this policy shall be monitored using both quantitative and qualitative measures. Performance indicators may include number of incidents reported, near miss reporting rates, incident investigation timescales, completion of action plans, staff training compliance, patient complaints, clinical audit findings, repeat incidents, learning implementation rates, and Duty of Candour compliance.

The purpose of monitoring is continuous improvement rather than performance management.

29. Annual Patient Safety Review

The Clinical Governance Committee shall receive an Annual Patient Safety Report summarising organisational performance over the preceding twelve months. The report should include incident statistics, harm categories, learning responses undertaken, themes identified, audit outcomes, complaints relating to patient safety, Duty of Candour compliance, action plan completion, emerging risks, and recommendations for future improvement. The report shall inform organisational priorities for the following year.

30. Risk Management

Patient safety risks identified through incident reporting, audit or complaints shall be recorded within the organisational Risk Register. Each identified risk shall include a risk description, cause, consequence, existing controls, risk rating, further mitigation required, responsible owner, and review date. High-risk items shall be reviewed at each Clinical Governance Committee meeting.

31. Confidentiality

Information relating to patient safety incidents shall be handled confidentially. Patient identifiable information shall only be accessed where there is a legitimate clinical or governance need. Processing of information shall comply with the UK General Data Protection Regulation (UK GDPR), the Data Protection Act 2018, the Common Law Duty of Confidentiality, Caldicott Principles, and the Direct Medicare Ltd Information Governance Policy.

32. Equality and Diversity

Implementation of this policy shall promote equality of opportunity and ensure that no patient, carer or member of staff is disadvantaged on the grounds of age, disability, sex, race, religion or belief, sexual orientation, gender reassignment, pregnancy and maternity, or marriage or civil partnership. Reasonable adjustments shall be made wherever necessary to facilitate effective communication and patient engagement.

33. Policy Review

This policy shall be reviewed every three years, earlier if there are significant legislative, regulatory or organisational changes, or following major patient safety incidents where revision is considered necessary. The Clinical Governance Committee shall be responsible for recommending amendments.

34. References

This policy has been developed with reference to current legislation and recognised guidance, including:

• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 – Regulation 20 (Duty of Candour).
• Health and Social Care Act 2008.
• Data Protection Act 2018.
• UK General Data Protection Regulation (UK GDPR).
• NHS England – Patient Safety Incident Response Framework (PSIRF).
• NHS England – Patient Safety Incident Response Standards.
• NHS Standard Contract (where applicable).
• Care Quality Commission Fundamental Standards.
• Professional guidance issued by the HCPC, GMC, NMC, and the Society and College of Radiographers (SoR), as applicable to staff roles.

Appendices

Appendix A – Patient Safety Incident Reporting Pathway

Appendix B – Incident Severity Guide

Appendix C – Learning Response Decision Guide

Appendix D – Duty of Candour Checklist

Following an incident where the Duty of Candour applies, the responsible clinician or manager should ensure:

• The patient has received any necessary immediate clinical care.
• A verbal explanation of the incident has been provided openly and compassionately.
• A sincere apology has been offered.
• The patient has been informed of the review process.
• Questions have been answered honestly.
• A written summary and apology have been provided where appropriate.
• All communications have been documented in the patient’s clinical record.
• Appropriate follow-up arrangements have been made.

Appendix E – Roles and Responsibilities Summary