The roles and responsibilities of Health Managers in Open Disclosure and Incident Management, the culture around it and the training required by all staff, were spelled out by Angela Tysall and Lorraine Schwanberg, at a HMI East Regional Seminar on August 14.
The meeting was chaired by Catherine Stuart, Head of Adult Services, CRC and Committee Member, HMI East Region, questions were moderated by Mellany McLoone, HMI Council Member and Chief Officer of Community Healthcare Organisation Dublin North City and County and the meeting was sponsored by GSK.
The presentations included:
- The definition of an Incident.
- Notifiable Incidents.
- How they should be managed.
- The culture of quality and safety.
- Leadership and Governance.
- What is Open Disclosure.
- The obligation to make an Open Disclosure.
- An apology.
- The Patient Safety Act2023 and its benefits.
- Open Disclosure Training
What is an Incident
- Patient safety incidents include harm events, suspected harm events, no harm events and near miss events.
- An event or circumstance which could have or did lead to unintended and/or unnecessary harm.
- Adverse events which resulted in harm.
- Near misses which did not cause harm either by chance or timely intervention.
- Staff/service user complaints associated with harm.
- Incidents can be clinical (Patient Safety incident) or non- clinical.
Notifiable Incidents are:
Unintended and unanticipated patient death which did not arise from/was a consequence of an illness/underlying condition, including:
- Following wrong patient surgery.
- Following wrong site surgery.
- Following wrong surgical procedure.
- Following unintended retention of foreign object.
- Following elective surgery (otherwise well).
- Directly related to medical treatment.
- Due to transfusion of incompatible blood or blood components.
- Associated with medication error.
- Unanticipated death of a woman while pregnant or within 42 days of the end of pregnancy from any cause related to, or aggravated by, the management of the pregnancy.
- Stillborn child born without foetal abnormality at prescribed gestational age/birth weight, from any cause related to or aggravated by the management of the pregnancy, not related to underlying condition of the child.
- Perinatal death of a child born with, or having achieved, a prescribed gestational age and a prescribed birthweight who was alive at the onset of care, from any cause related to, or aggravated by, the management of the pregnancy, not related to an underlying condition.
- Suicide of a patient while being cared for in or at a place or premises in which a health services provider provides a health service.
- A baby that requires or is referred for therapeutic hypothermia or has been considered for and did not undergo therapeutic hypothermia due to severity of condition.
NOTE: The Minister has reserved the right to make further regulations (additions to the list above)
Open Disclosure Process
- There is an obligation to make an open disclosure of a notifiable incident by the principal health practitioner (unless not available or health service provider seeks alternative).
- The health services provider shall take all steps reasonably open to it to make the open disclosure as soon as practicable.
- There is an obligation to notifyHIQA, the Chief Inspector of Social Services and/or the Mental Health Commission by health services providers of the Notifiable Incident within 7 days.
Preparing for Open Disclosure
- Prepare for open disclosure (consider facts, with whom it is made, etc).
- The appointment of a designated person
- The open disclosure meeting will generally be held in person and should cover incident, potential harm (physical/psychological), names, dates, actions taken by the health service, apology. This needs to be followed up in writing within 5 days (statement).
- Persons to whom open disclosure of notifiable incident is made (patient/relevant person or both).
Information and Apology
Information and apology not to invalidate insurance; constitute admission of liability or fault; or not to be admissible in proceedings.
The Incident Management Framework and Guidance 2020
This states that it is the policy of the HSE that all incidents are identified, reported and reviewed so that learning from events can be shared to improve the quality and safety of services.
The Incident Management Framework (IMF) sets out the principles, governance requirements, roles and responsibilities and processes to be applied for the management of incidents in all service areas (pathways)
Incident Management Framework Principles stipulate that management be Just & Fair, Person-Centred, Responsive, Open and Transparent, Learning, Improvement Focused.
The IMF is consistent with legislative and regulatory requirements.
- The services are supporting a culture where safety is a priority.
- Clear leadership and governance arrangements at all service levels are important to support a culture of quality and safety
- We should anticipate and manage risk which may lead to incidents by ensuring that any controls required to mitigate it are in place.
- We should clearly define the structures and processes for incident management to ensure effective governance and operational efficiency.
- We should integrate quality and safety information to enhance its effectiveness.
- We should identify the responsibilities for Incident Management as set out in the Incident Management Framework (IMF).
- The needs of persons affected i.e. service users, relevant person(s) and staff, should be identified and supported.
What Is Open Disclosure
Open disclosure is defined as an open, consistent, compassionate and timely approach to communicating with patients and, where appropriate, their relevant person following patient safety incidents. Open Disclosure is the right thing to do and it is important that we do it correctly.
It includes expressing regret for what has happened, keeping the patient informed and providing reassurance in relation to on-going care and treatment, learning and the steps being taken by the health services provider to try to prevent a recurrence of the incident. (HSE 2019)
Open Disclosure is a discussion and an exchange of information that may take place in one conversation or over one or more meetings.
The ethos of the National Open Disclosure Policy and Programme is based on ensuring that the rights of all patients (and their relevant persons, as appropriate) to be communicated with in an open, honest, timely and empathic manner following patient safety incidents are met and respected and that they experience dignity, respect and compassion throughout that communication process.
The open disclosure process must be initiated as soon as is reasonably practicable and ideally within 24-48 hours after the incident occurs or becomes known to the service provider or as soon as the service user or relevant person(s) is available physically and emotionally to take part in the discussion
Information provided and an apology given at an open disclosure meeting:
- Shall not constitute an express or implied admission of fault or liability in relation to the incident or any clinical negligence action arising from the incident
- Will not be admissible as evidence of fault or liability in Court in relation to the incident or clinical negligence action arising from the incident
- Will not invalidate the indemnity or insurance cover of the health service provider
- Shall not constitute an express or implied admission of fault, professional misconduct, poor professional performance or unfitness to practice in relation to any complaint made by the patient to a regulatory body subsequently.
- Shall not be admissible as evidence of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in proceedings to determine a complaint, application or allegation
This Relates to Voluntary Open Disclosure
Protections apply only when Open Disclosure is managed strictly in accordance with the provisions of the legislation and completion of documentation as set out in the Act.
The Civil Liability (Open Disclosure) ( Prescribed Statements) Regulations 2018 are prescribed statements (forms) to be completed, signed and provided to the patient/relevant person at various stages throughout the OD process.
Protective legislative provisions in Part 4 of the Civil Liability Act commenced in September 2018
The legislator basis for Open Disclosure is the Civil Liability (Amendment) Act 2017, (Part 4), Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018 and the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, signed into law May 2, 2023
The Patient Safety Act 2023 provides for:
- Mandatory open disclosure of serious notifiable patient safety incidents.
- Certain restrictions on the use of the information and any apology provided in such disclosures.
- Mandatory open disclosure of patient requested reviews (Part 5 Reviews)(Bowel, breast and cervical screening programmes).
- Procedures in respect of clinical audit, and the data obtained in clinical audits.
- The notification of notifiable incidents to certain agencies i.e. HIQA, MHC, Chief Inspector.
- The amendment the Health Act 2007 to provide for the application of standards set by the Health Information and Quality Authority to private hospitals.
- The review by the chief inspector of certain incidents occurring in the course of the provision of a health service to a person by certain entities.
- To amend the National Treasury Management Agency (Amendment) Act 2000 and Part 4 of the Civil Liability (Amendment) Act 2017.
Benefits of Patient Safety Act
- Establishes a legal requirement for open disclosure and strengthens open disclosure policy.
- Makes provisions for open disclosure of patient requested reviews in relation to screening (called Part 5 Reviews).
- Requires notification of certain specific incidents (notifiable incidents).
- Sets out clear and few exemptions for open disclosure.
- Extends the remit of HIQA to private hospitals.
- Strengthens and makes clear provision for the role of the designated person.
- Makes amendments to current legislation such as CLA Amendment Act 2017.
The Patient Safety Act: Open Disclosure of a patient-requested review
The Patient Safety Act outlines that a patient can request a review of the result of their screening (Bowel, breast or cervical)that has been carried out by a cancer screening service (formally called a Part 5 review).
The patient is provided with the results in a open disclosure meeting, and the same requirements and responsibilities apply as for the notifiable incident disclosure meeting.
For example, it is also a requirement that open disclosure must take placefollowing the review of the screening results, despite the unavailability of part of the informationthat relates to the review.
Equally, information and apology given at a patient-request review open disclosure meeting will not invalidate insurance, constitute admission of liability or fault or be admissible in legal and employment proceedings.
A health services provider must inform a patient who is to undergo or who is undergoing cancer screening of their right to request a patient-requested review.
Patients who have already had a cancer screen, prior to the implementation of the Act, must be informed of their right to request a patient-requested review.
Patient Safety Act Part 8: Offences and Penalties
A person who fails to comply (with the obligation to make an open disclosure of a notifiable incident or patient requested review) without a reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a Class A fine (the fine may vary up to €5000).
The above relates to failure to hold an open disclosure meeting and/or to report the patient safety incident to the relevant authority e.g. HIQA, Chief Inspector, Mental Health Commission.
Implementation of the Patient Safety Act 2023
HSE Patient Safety Act Implementation Group
As part of the HSE’s preparation for the commencement of the 2023 Act, the HSE Patient Safety Act Implementation Group, chaired by Dr Orla Healy (National Clinical Director for Quality and Patient Safety), was established by the Chief Clinical Officer.
This group is tasked with developing an implementation plan for the Act across HSE and HSE-funded services.
The development of the implementation plan will consider the full implications of the 2023 Act.
The group’s membership draws from stakeholders across the health and care system and includes patient-representatives and advocates; subject matter experts and clinicians; representatives from the Department of Health and from across HSE and legal consultants.
National Open Disclosure Framework for Irish health and social care services
Aim of the Framework
- To provide a unified and consistent approach to open disclosure across public and private health and social care service providers, service regulators, and health and social care professional regulators, health and social care educators, and other relevant bodies and organisations.
- To further embed a culture of open disclosure across the entirety of health and social care services and in the practice of all health and social care professionals.
All stakeholders should adopt the Framework and identify mechanisms and initiatives that will support the embedding of a culture of openness, and the consistent, coherent, and sustainable implementation of open disclosure in their organisations.
Framework applies to:
- Health Service Executive.
- Voluntary Hospitals.
- Private Hospitals
- Nursing Homes.
- Residential Care Settings.
- Outpatient Health Services.
- Primary Care Health Services.
- National Ambulance Service.
- Health Information and Quality Authority.
- Mental Health Commission.
- Irish Medical Council.
- Nursing and Midwifery Board of Ireland.
- Dental Council of Ireland.
- Pharmaceutical Society of Ireland.
- Pre-hospital Emergency Care Council.
- Education and Training Bodies.
- Providers of Health Service Workers.
- All other providers of health and social care services, including private practitioners regulated by any of the professional and service regulators listed above.
Overview of Framework content
- Framework Principles for Open Disclosure:
- Open, Honest, Compassionate, and Timely Communication.
- Patient/Service User and Support Persons’ Entitlements in Open Disclosure.
- Supporting Health and Social Care Staff.
- Promoting a Culture of Open Disclosure.
- Open Disclosure for Improving Health and Social Care Policy and Practice.
- The Importance of Good Clinical and Corporate Governance for Open Disclosure.
- Open Disclosure in Practice (Health Service Providers).
- Open Disclosure in Practice (Non-Health Service Providers) – regulators, training and education bodies, clinical placement sites, undergraduate and postgraduate education including continuing professional development training, professional practice, workplace policies and procedures, and regulatory standards and guidance.
- Drivers for Change.
- Monitoring and Evaluation.
Open Disclosure Training and Performance Measurement
National training programme.
Open Disclosure training is mandatory for all staff since January 2019 – level of training depends on role.
Launch of Module 1 of the accredited online programme on HseLanD April 2020 “Communicating effectively through Open Disclosure.”
Launch of Module 2 of the accredited online programme April 2021 “Open Disclosure: Applying Principles to Practice”
Advanced, accredited face to face programme to complement online modules.
Revised train the trainer programme for new face to face programme.
National trainers database – trainers in all health service areas.
All staff must complete Module 1 on HSeLanD.
Staff who may be involved in high level open disclosure meetings must also complete Module 2 on HSeLanD and 3 hour face to face skills training.
Refresher training is required every 3 years for all staff.
Staff who may be involved in high level open disclosure meetings must refresh by the completion of Module 2 or attendance at a face to face skills workshop.
CPD: All training is CPD accredited by the RCPI and NMBI.
Open Disclosure Leads and Trainers
Open Disclosure Leads are present in:
- Hospital Groups (with site leads in each hospital).
- Screening services.
- Many of the voluntary agencies.
- A list of leads is available online here
- The role of the lead is to coordinate, oversee and support this programme in liaison with the relevant stakeholders e.g. service managers, Senior Clinicians, site leads, QPS/QSSI leads, trainers, persons who are assigned to the role of Designated Person and Staff Support Persons.
The role of Managers in Open Disclosure Implementation
Create a caring and compassionate culture in the workplace – a culture that promotes incident reporting, disclosure, learning and quality improvement.
Be open, accessible and transparent in all communications with staff.
Ensure your service has an Open Disclosure Policy.
Participate in open disclosure meetings as required and in a manner which is honest, compassionate, caring and empathic.
Ensure that a designated person is assigned for patients and families involved in Category 1 and Category 2 incidents. Promote and offer the support of independent advocacy early in the process.
Be accountable for the management of incidents including requirements in relation to open disclosure. Ensure that there are systems and structures in place to address the support needs of persons affected (patients, their relevant person(s) and staff) as a consequence of patient safety incidents.
Support and enable staff to participate in the incident management, incident review and open disclosure process.
Ensure that open disclosure is recorded/documented appropriately -including the recording of open disclosure on the National Incident Management System and in the clinical/care record.
Oversee the implementation of the HSE/Service Open Disclosure Policy at service level – the implementation plan must consider (i)accountability arrangements for Open Disclosure at every level in the organisation, (ii) any specific requirements of the service and patients accessing that service i.e. any specific support(s) required by patients to enable them to participate in open disclosure meetings for example communication supports or independent advocacy.
Ensure that open disclosure is embedded in the service’s governance programme/framework and the learning from the open disclosure process is shared and included in the service Quality Improvement Plan.
Monitor compliance with the policy.
Identify and proactively manage incidences of non-compliance and underperformance – escalate to the Senior Accountable Officer(SAO), as necessary.
Provide performance reports to the SAO in relation to incident reporting, incident management and open disclosure within your area of responsibility.
Ensure that staff reporting to you are aware of their obligations in relation to open disclosure – policy, professional, ethical, regulatory and legal
Identify clinical and managerial champions to promote, lead and oversee open disclosure policy and practice.
Ensure that all staff have attended training relevant to their role in open disclosure and attend refresher training 3 yearly.
Open Disclosure: Providing a safe, supportive environment for staff
Provide a safe, supportive and caring environment for staff involved in or affected by patient safety incidents.
Ensure that the impact of patient safety incidents on staff is recognised and managed in a caring, supportive and compassionate manner.
Provide services to support staff who are involved in and/or affected by patient safety incidents.
Ensure that staff have access to training on the open disclosure policy relevant to their role.
- Staff Support Resource: List of staff support services and resources for staff following an incident available online here
- Early assignment of designated person (key contact person)
- Early promotion and offer of independent advocacy services
- Open Disclosure Patient Information leaflet available online here
- List of support service available for Patients and Service Users following patient safety incidents available online here