Varadkar announces major package of patient safety reforms


Minister for Health Leo Varadkar has announced a major package of patient safety reforms including plans to simplify the complaints procedure, enhance the powers of the Ombudsman and HIQA, and a tranche of patient safety legislation.  In addition, he is collaborating with Frances Fitzgerald, Minister for Justice and Equality on measures to reduce the time taken for a legal action to be resolved and to reform methods of compensation payments.

The measures also include plans for an annual national patient experience survey, the creation of a National Patient Safety Office and a patient advocacy service to provide advice and detect worrying patient safety trends in healthcare. They were agreed at Cabinet this week and formally announced by the Minister at the Fifth National Patient Safety Conference in the Aviva Stadium today.

Minister Varadkar said: “Patient safety should be at the heart of everything we do as a health service. Although progress has been made in some areas, there have been some very high-profile and tragic exceptions which have damaged public confidence in the health service. That’s why we have prepared the most wide-ranging package of patient safety measures in Irish history.

“For patients and their relatives, the experience of making a complaint can be bewildering. We will simplify the complaints process and look to extend the powers of the Ombudsman to cover clinical issues. The annual patient experience survey will also give us first-hand feedback. We can learn a lot by listening to patients and knowing more about how they rate individual hospitals or services. A package of legal reforms will reduce the length of court cases, while plaintiffs will be entitled to regular index-linked compensation payments instead of a lump sum. Open Disclosure, where healthcare professionals are open and transparent with a patient following an adverse incident, will be supported through legislation. The National Patient Safety Office will help to drive the overall patient safety agenda. All these initiatives should put the patient first, improve their experience of the health service, reduce harm and reduce costs, and ultimately save lives.”

The general patient safety measures comprise:

· Simplify the complaints process and look to extending the remit of the Ombudsman across the health service in consultation with the Department of Public Expenditure and Reform and other interested parties;
· Conduct a National Patient Experience Survey across all hospitals. This survey will be conducted annually using recognised guidelines to allow international comparisons;
· The National Healthcare Quality Reporting System, first published in 2015, will continue to be published annually;
· Run ongoing Patient Safety Campaigns with defined safety targets such as reducing medication errors;
· Set up a National Patient Safety Office in the Department of Health to report directly to the Minister, oversee the programme of patient safety measures and advise the HSE, HIQA and health professional regulatory bodies on patient safety issues;
· The Patient Safety Office will be guided by an independent Advisory Council, established through public invitation from the Public Appointments Service. This will advise the Office, publish independent patient safety reports prompted by safety information, and act as an early-warning mechanism;
· Set up an independent National Patient Advocacy Service as recommended in the HIQA Portlaoise Report to provide advice and information directly to patients;
· Implement the Code of Conduct for Health & Social Care Providers;
· A National Patient Safety Surveillance System will collate data from across the health service to help the HSE to monitor patient safety, and to guide Government health policy.

There is also a package of patient safety legislation aimed at patients including:

· The Health Information & Patient Safety Bill, the general scheme of which was published today, will make it mandatory to report events which result in death or serious harm;
· Under this Bill HIQA’s remit on setting standards, monitoring compliance with standards and carrying out investigations will be extended to private operators, including private hospitals, and high risk activities in cosmetic surgery clinics;
· Periodic Payment Orders will allow people who experience serious injury during healthcare to receive the cost of future care in the form of index-linked payments every few years, instead of the current system of lump-sum awards (through Department of Justice and Equality legislation);
· Open Disclosure will be supported through legislation to support the system currently in operation in the health service (again through the Periodic Payment Orders legislation);
· Pre-Action Protocols will reduce the length of time required to complete legal proceedings and the cost involved, and reduce the stress for plaintiffs and their families (through a Bill from the Department of Justice & Equality);
· The enactment of the Medical Practitioners Bill in the coming months to require that all doctors who practise medicine must provide evidence that they have adequate indemnity cover when they register with the Medical Council or on annual retention of registration;
· Patients will have a right to transfer their medical records when they change GP or health professional;
· It will be a criminal offence for those involved in healthcare to buy or sell personal health information;
· A Patient Safety Licensing Bill is being developed to introduce a formal licensing regime for public and private healthcare providers.


Further information below

Further information

Note for Editors
Cross Departmental Approach to Tort Reform and Legislation
The Government has given its approval to the drafting of provisions to support Open Disclosure of patient safety incidents.  This will be included in the Department of Justice and Equality’s draft Bill on Periodic Payment Orders which is well advanced. The legislation is part of a broader package of reforms aimed at improving the experience of those who are affected by adverse events. With the enactment of Periodic Payment Order legislation catastrophically injured people will receive the cost of future care in the form of index-linked payments every few years, instead of a lump sum award, which is what they must rely on under the present system.

This legislation builds on the joint development by the HSE and State Claims Agency of the National Policy on Open Disclosure.  It is now two years since this policy was launched by the HSE, but perhaps its full impact will not be felt until this legislation is put in place.

The Department of Justice and Equality is also preparing legislation, as part of a Legal Services Bill, to introduce Pre-Action Protocols which will facilitate more efficient processing and conclusion of court cases. This is in everyone’s interest as it will considerably reduce the length of time that it takes to complete legal proceedings and the cost of those proceedings.  This, in turn, should also reduce the stress involved for plaintiffs and their families.

In addition Government agreed last month that there will be a review of the State Claims Agency and how clinical negligence claims are handled.

Medical Practitioners Amendment Bill
Legislation which was passed in the Seanad last week will be enacted in the coming months, which will require that all doctors who practise medicine must provide evidence that they have adequate indemnity cover when they register with the Medical Council or on annual retention of registration.  The minimum levels of indemnity for all types of medical practitioner will be set by the State Claims Agency. Currently some doctors consider that they have adequate cover, but this may not be the case.

Health Information and Patient Safety Bill
The Government approved on Tuesday 10th November, 2015 the drafting of the Health Information and Patient Safety Bill. The Bill will cover a range of issues including measures to support clinical audit and patient safety incident notifications. The adverse incident reporting and clinical audit measures in the Bill will help promote a culture of patient safety and build a health service which can identify, respond to and learn from error and monitor and commit to on-going quality improvement through identifying opportunities for improvement.

The Bill also facilitates the appropriate sharing of information between regulatory bodies where the disclosing body has a reasonable belief that the information is relevant to other regulators.

The Minister is adopting a phased approach to the regulation of healthcare services. The Government has given approval to allow the Department to draft amendments to the Health Act 2007 which will allow HIQA to set and monitor standards in private hospitals and for certain cosmetic surgery procedures. These measures have been included in the Health Information and Patient Safety Bill which will be drafted in 2016. In addition a Patient Safety Licensing Bill is being developed which will introduce a formal licensing regime for public and private healthcare providers.

Patient Complaints and Advocacy
The management of clinical and non-clinical complaints is being examined. Currently there is a distinction between the management of clinical and non-clinical complaints. It is the Minister’s intention to ensure that patient complaints relating to clinical issues can be dealt with in the first instance by health service providers and, therefore, by extension by the Ombudsman.
In addition work on a new independent national model for patient advocacy as recommended by the HIQA Portlaoise Report has commenced. This advocacy service will be external to the Department and the HSE and will be in line with international best practice.

Health Intelligence and Patient Experience
In March this year the first annual report of the National Healthcare Quality Reporting System was published. This system will publicly report on an annual basis on performance indicators that reflect on the quality of the healthcare provided at national, regional and hospital level. This will allow comparison on the quality of healthcare across our country and at international level.

One of the recommendations of the CMO’s Report into Portlaoise was the development of a National Patient Safety Surveillance System.

A National Patient Safety Surveillance System will be established in 2016.  This will produce patient safety profiles by bringing together data from various health information resources and the intelligence gathered will inform the setting of priorities for the HSE and the monitoring of implementation.

Starting next year it is intended that national patient safety campaigns directed by priority patient safety areas, for example, targeting medication errors will take place.

Appointment of a National Advisory Council for Patient Safety
A National Advisory Council for Patient Safety is to be appointed in early 2016. This Council will have an independent chair, significant representation from healthcare leaders and from patients. Membership will be selected through public invitation from the Public Appointments Services. This Council will provide advice and guidance to inform the policy direction for the Department’s new National Patient Safety Office in its delivery of three core functions; patient safety surveillance, patient advocacy and building further the work of the National Clinical Effectiveness Committee.

The National Advisory Council for Patient Safety will publish independent patient safety reports to be laid before the Houses of the Oireachtas. They will be reports, which through the interrogation of patient safety information will assist the health service and regulators to recognise the conditions that help predict whether harm is likely to occur.

Clinical Effectiveness
The National Clinical Effectiveness Committee (NCEC) is a ministerial committee which was established as part of the Patient Safety First Initiative. The NCEC is a partnership between key stakeholders in patient safety.

The NCEC, through its terms of reference, provides a framework for national endorsement of clinical guidelines and audit to optimise patient and service user care. High quality guidelines are the internationally recognised method of directing evidence based practice and reducing variation of practice, thereby improving clinical outcomes and patient safety. It is intended, as agreed with the Director of Clinical Programmes, that the National Clinical Guidelines will underpin the models of care.

Ten NCEC National Clinical Guidelines have been published to date and a further four will be published by the end of November.

Progress in Patient Safety
The Department has mandated the HIQA National Standards for Safer Better Healthcare. These standards provide all healthcare providers with a blueprint for safe and effective care which places the patient at the centre of the way care is delivered. The process of implementation and monitoring against these Standards by the HSE and HIQA is ongoing.

Earlier this year the National Women & Infants Health Programme was established to standardise and improve maternity services across the country. The National Maternity Strategy being developed will provide the policy to underpin the Women & Infants Health Programme.  The Strategy Steering Group to advise on the Strategy has continued to meet during 2015 and it is expected that the Group will report early in December.

A new National Incident Management System called NIMS was introduced in 2014 and since June 2015 all incidents in the healthcare sector are now being reported directly on to NIMS. It facilitates more detailed and consistent reporting of incidents.

In addition a new maternity patient safety statement has now been introduced in all 19 maternity units. The next phase is to introduce a patient safety statement across all acute hospitals. These statements will report monthly on key patient safety trends such as complaints, sepsis rates etc., will be published regularly by hospitals and be the basis for on-going patient safety improvement programmes.

A number of national patient safety guidelines to target standardised approaches to the management of clinical deterioration, clinical handover and sepsis have been published by the National Clinical Effectiveness Committee and are in the process of being fully implemented in the health service.

An Oversight Group has been established chaired by the Chief Medical Officer of the Department to oversee, report on and highlight the extent of progress being made on the implementation of the HIQA Portlaoise recommendations.

The Department has recently completed work on the development of a ‘Code of Conduct for Health and Social Service Providers’ that clearly sets out employers’ responsibilities in relation to achieving an optimal safety culture, governance and performance of the organisation.

Date: 12. 11. 2015