Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

We have a slightly unusual procedural situation as this is very comprehensive legislation with many sections. With any Bill I have ever seen introduced, the Minister obviously goes through all the sections. However, this would take over twice as long as the time I have for my opening statement so, with colleagues' agreement, I will speak very briefly to the totality of the Bill and start to go through the sections. We will have provided printed copies so colleagues will have the full speech covering all of the sections but I do not have time to speak to all of them. I hope it is within procedure for me to do that.

I will start with the objectives of the Bill. The first objective is mandatory disclosure of patient safety incidents. It ensures that the most serious incidents are covered in primary legislation and can be added to. Some of the questions raised previously concerned the Schedule towards the end of the Bill, which lists a relatively small number of incidents that are the most serious incidents. Deputies questioned whether it was intended to leave it at this limited number.I assure Senators that that is not the case. In fact, the reason we have the Schedule at the back is to say that these are incidents that are so serious that it would require a change in the primary Act to remove them as notifiable incidents. It is my intention that the categories of patient safety incidents will be added to significantly. It is important this is done through regulation rather than primary legislation so we can keep apace of changes to clinical practice, new procedures, new services and so forth.

The initial objectives of the Bill, when it was introduced some time ago, were to provide for mandatory disclosure for patient safety incidents; to provide a framework for clinical audit to take place, which is important for getting better at patient care and improving patient outcomes; and to expand HIQA's powers into private hospitals, which is also very important. On Committee Stage, I signalled that there were additional substantial amendments that I would propose on Report Stage in the Dáil. The first was to extend HIQA's powers to investigate patient safety incidents in nursing homes, which it currently cannot do in response to an individual incident. The second was to introduce mandatory disclosure of patient requested reviews. I know there will be some debate on such reviews, which are an innovation that will make Ireland one of the leading countries in the world in terms of patients having control of their own information and a right to a full look-back at their clinical and screening history. The third amendment was to provide for a review of the legislation after two years.

We had a very constructive debate on Report Stage. We adjourned the debate and I recently proposed three additional amendments. The first was to make it mandatory to inform patients of their right to a patient-requested review before or during screening. Second, we made it mandatory to inform patients of their right to a patient-requested review after screening, in other words, they are informed after screening. We also made it mandatory to provide information on a patient-requested review online. We will come back to some of that. We had constructive cross-party engagement in the House and important engagement with patient representative groups, including the 221+ group.

I have given a broad overview of this important Bill, which will mark a fundamental change to a culture of openness and transparency, and much more. I will now go straight to the sections and we will progress through as many of them as possible in the time available.

Part 1 is on preliminary and general provisions and covers sections 1 to 4, inclusive. Section 1 contains standard provisions setting out the Short Title of the Bill and arrangements for its commencement on a phased basis. Section 2 deals with the interpretation of the Bill and defines the meanings of some of the terms used for the purposes of the Bill. Section 3 provides for the definition of a health service provider encompassing a wide range of providers of health services both public and private. Section 4 deals with expenses.

Part 2 sets out the framework for mandatory open disclosure of a notifiable patient safety incident. Section 5 places an obligation on the health service provider to make an open disclosure when satisfied that a notifiable patient safety incident has occurred. Section 6 places an obligation on a health practitioner, where he or she has formed an opinion that a notifiable incident has occurred, to inform the health service provider of that incident. Section 7 is important in that it establishes the obligation of mandatory open disclosure. This section requires that a health service provider must make an open disclosure to the patient concerned where a notifiable patient safety incident has occurred. If the patient has died or there are concerns regarding the capacity of the patent, this section also recognises that it may be more appropriate to make the disclosure to another relevant person.Section 8 is also a key provision and provides for the Minister for Health to make regulations prescribing additional patient safety incidents as notifiable incidents. This is an important function. We do not want to have to go back to primary legislation every time we need to add to the Schedule. Having that flexibility through regulation to revise this list is a practical way of ensuring we can keep the law up to date as health services evolve.

All notifiable patient safety incidents, whether listed in the Bill or prescribed in regulations, are subject to mandatory open disclosure and must be notified by the health service provider to the appropriate regulator. This section is intended to ensure that the list of notifiable patient safety incidents subject to mandatory open disclosure can be kept up to date. The section gives the Minister wide scope to prescribe further patient safety incidents as notifiable incidents.

Section 9 provides that when a health service provider engages in open disclosure in accordance with the Act, the disclosure, including an apology, shall be treated as an open disclosure of a notifiable patient safety incident.

Section 10 sets out that the information and apology given at an open disclosure notifiable patient safety incident meeting shall not: constitute an express or implied admission of fault or liability; be admissible as evidence of fault; invalidate insurance; or constitute an express or implied admission by a health practitioner of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission in notifying a notifiable patient safety incident. The purpose of these legislative provisions, which are very much in line with international experience and best international practice, is to encourage an environment of open disclosure by ensuring that information regarding notifiable patient safety incidents can be disclosed by health practitioners and health service providers without fear of liability.

Section 11 provides that a health service provider must set out in writing its procedures for making open disclosures of notifiable patient safety incidents to patients.

Section 12 addresses openness and transparency and sets out that both health service providers and health practitioners, when making an open disclosure under this Bill, must provide all relevant information to the patient, or his or her relevant person, and, where appropriate, any other health service to address the consequences of that incident.

Part 3 addresses the procedure for making an open disclosure of a notifiable incident. Section 13 requires that an open disclosure must be made on behalf of the health services provider by the principal health practitioner. If the principal health practitioner is not available, or not in a position to make the open disclosure, the health services provider will identify an appropriate health practitioner to make the disclosure.

Sections 13 to 25, inclusive, set out detailed procedures for: making of open disclosures; timing of making same; matters to be considered before open disclosure; designated contact persons; in-person meetings, or alternatives where necessary; conduct of open disclosure meetings; procedures where a patient chooses not to participate and the five year period within which they can change their mind; procedures for establishing contact; procedures for additional required meetings and clarifications; and, procedures for written statements and the maintenance of records.

Part 4 addresses the notification to certain regulatory bodies of notifiable incidents. Section 26 is the interpretation section for Part 4. Sections 27 to 29, inclusive, set out that a health services provider under the remit of HIQA, the chief inspector of social services or the Mental Health Commission, as appropriate, will make a notification as soon as practicable and not later than seven days from when the provider is satisfied that an incident has occurred. The notifiable incidents are those specified in Schedule 1 and those specified in regulations to be made under section 8. I will leave it at that for the moment.