Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I move: "That the Bill be now read a Second Time."

I am pleased to have the opportunity to introduce the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019. On 3 December last, the Government approved the publication of this Bill. I believe strongly that this legislation heralds a new era for the health service. This House will be familiar with some of the issues that have arisen within our health service in recent years that have, quite rightly, led to demands for improvements in patient safety. Any patient safety incident significantly affects patients' lives and impacts on their families. Quite often, that pain is compounded by poor communication.

I think today of people like Roísín and Mark Molloy, incredible patient advocates who lost their baby, Mark, in the Midland Regional Hospital, Portlaoise. They advocated so much for open disclosure. I also think of the incredible Vicky Phelan. These are people who have been kept in the dark about their own healthcare or that of a loved one. They have led us on the road to today and I formally thank them here on the floor of Dáil Éireann today. I also want to send a message to our doctors, clinicians and all those working in the health service. This legislation is not about a blame culture or finger pointing. It is about supporting those people in doing their jobs and about creating a culture in the health service where open disclosure and transparency are the norm. I know there are concerns and I can understand why.

When it comes to open disclosure, we must all become better at responding when things go wrong. Let us be honest. In every health service the world over, things will go wrong. What matters is how the health service responds and deals with situations when those mistakes and errors happen. We have now seen several good examples of responding when things go wrong, but this House and the media must also reflect on our reactions once the news of such incidents breaks. I believe we will succeed in creating the kind of culture we desire, but it will, inevitably, mean that more incidents will be discovered and disclosed. This means a more balanced analysis will be required in future. If mandatory open disclosure becomes the norm, and it will under this legislation, that will mean that, quite rightly, we will be hearing about more patient safety incidents. We need to debate that as an Oireachtas, a country and a health service in a balanced way and in a way that recognises that identifying errors and putting up one's hand and saying "I made a mistake, I got it wrong, I am sorry and here is the learning" is actually a good culture to embed in our health service.

The Patient Safety (Notifiable Patient Safety Incidents) Bill 2019 is part of a programme of legislative changes and policy initiatives being taken by my Department to improve the ability of our health service to anticipate, identify, respond to and manage patient safety issues. I hope the Bill will also change the culture within the health service. This Bill provides for a number of patient safety priorities, including mandatory open disclosure of serious patient safety incidents. It also provides for the notification of those reportable incidents to the relevant regulator, and it is an important point that the regulator has to be notified, the use of clinical audit to improve patient care and outcomes and, importantly, the extension of the remit of HIQA to private hospitals. That is something for which there have been calls for many years and it will now happen in this legislation.

This Bill is divided into eight Parts, with 54 sections and two Schedules. The first Part, preliminary and general provisions, 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. It defines the meanings of some of the terms used for the purposes of the Bill, including "apology", "health practitioner", "health service", "notifiable incident", "open disclosure of a notifiable incident", "patient" and "relevant person". Section 3 provides the definition of a "health service provider", which encompasses a wide range of providers of health services, 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, when he or she has formed the opinion that a notifiable incident has occurred, to inform the health services provider of the incident. Section 7 is a key section 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 patient, however, 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 of the Bill 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 come back to primary legislation every time we need to add to the Schedule of what is a patient safety incident. Having that flexibility through regulation to be able to revise that list is a practical way of ensuring we can keep this legislation relevant and up to date as our health service continues to 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 services 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, as I have said, be kept up to date on an ongoing basis. The section gives the Minister wide scope to prescribe further patient safety incidents as notifiable incidents, bearing in mind the learning from incidents that have occurred in the Irish health service or internationally, as well as learning from advances in clinical practice.

In prescribing new patient safety incidents as notifiable incidents, the Minister of the day must have regard to a number of matters, including: the nature of the incident; the consequences for the patient; and the need to obtain and disseminate information regarding an incident so as to prevent or lessen reoccurrence. Section 9 provides that when a health services 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; 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 relation to notifying a notifiable patient safety incident.

The purpose of these legislative protections, 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 relating to notifiable patient safety incidents can be disclosed by health practitioners and health service providers without fear of liability. It is a shame that, on many occasions, in the health service and in many other walks of life when something goes wrong, the first place the public service can run to is a lawyer. That is the culture we are trying to change. We are trying to create a safe space in which somebody can come forward and admit an error happened. As Dr. Scally said in his report, we must acknowledge the error, apologise for it, mean it and learn from it. That is at the core of what mandatory open disclosure has to be about. That is why these protections are in the legislation. The following terms are also defined in this section: "clinical negligence"; "clinical negligence action"; "medical defence organisation"; and "professional indemnity insurance".

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. It is one matter to do open disclosure. How open disclosure happens is equally important. I have met patients who have been openly disclosed to but in a less than satisfactory manner. 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.

Section 14 requires the health services provider to take all reasonable steps to make the disclosure to the patient and-or his or her relevant person as soon as practicable, having regard to the circumstances of the notifiable patient safety incident. Section 15 details matters to be addressed by the health services provider before making the open disclosure of the notifiable patient safety incident. These matters include the appropriate time, given an assessment of the circumstances; to whom the disclosure should be made; the making of an apology; the complexity of the information; the assignment of a designated person to liaise with the patient; and preparing a statement in writing about the incident.

Section 16 provides for the designation by health services providers of a person to act as a designated contact person for the patient or family in relation to the open disclosure. Section 17 requires that the open disclosure meeting will be held in person, unless the patient and-or his or her relevant person requests that it be held by telephone or other method of communication. Again, this shows the patient-centred approach.

Section 18 requires the health services provider to make arrangements for the open disclosure meeting with the patient and-or his or her relevant person. This includes the information that must be given orally at the meeting and in writing within five days of it. This is important as somebody could be at a vulnerable stage of his or her life. The person would be going into a meeting with much information coming at him or her. This measure of a recap of that information in writing is important. This information must include names of the persons present at the meeting; a description of the incident concerned; the manner in which the incident came to the notice of the health services provider; the physical and psychological consequences of the incident for the patient; the treatment and care plan for the patient relating to any of the consequences arising out of the incident; actions, policies or procedures proposed or that have been taken by the health services provider to address the incident; and any apology to be made to the patient.

Section 19 makes it clear that a patient may choose not to participate in the open disclosure of a notifiable incident or may decline to accept written information regarding the incident. However, the patient may change his or her mind within five years from the day of refusal and request the health services provider to make the open disclosure. The provider is also required to keep a record of the refusal.

Section 20 requires a health services provider to take all necessary steps to contact a patient to arrange an open disclosure meeting. If a health services provider is unable to make contact with a patient, it must set out in writing the steps taken to establish contact. If the patient is later contacted, the health services provider must proceed to hold an open disclosure meeting.

Sections 21 and 22 contain provisions relating to a health services provider holding additional meetings with the patient and-or his or her relevant person to provide information that may not have been available originally. Section 23 provides that a patient, or relevant person, who attended an open disclosure meeting may, at any time, make a request to the designated person for clarification about the information provided. The clarification should be provided orally at a meeting and in writing as soon as practicable, either by the health practitioner who previously made the open disclosure or an appropriate alternative person, if necessary.

Section 24 sets out that a provider must provide the patient with a written statement on the incident either at the relevant meeting and not later than five days from the day on which the meeting was held. Section 25 details the records that must be maintained by the health services provider about a notifiable patient safety incident. The Minister may also prescribe in regulations the format of records to be kept and maintained.

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. The notification must include the name of the health services provider; the type of incident that has occurred; the date the notifiable incident came to the notice of the health services provider; any action that is being taken, or is proposed to be taken, to prevent a reoccurrence, or mitigate the consequences of any similar incident and for the purposes of sharing the knowledge and learning arising from it.

Section 30 provides that the method for making notifications to the bodies will be by means of the National Treasury Management Agency incident management system. Section 31 provides where a notifiable patient safety incident is reported to the relevant regulatory body, the regulator may request further information from the health services provider. Again, we are trying to learn from more than just individual incidents. If HIQA or the Mental Health Commission has to be notified of these incidents, it will create a wealth of information about patient safety standards across our health and social services.

Section 32 provides that the regulatory bodies may share information on these incidents with other health regulatory bodies, as well as with coroners, for the purposes of the safety of patients and if the information relates to the function of the relevant body. Section 33 clarifies information relating to these notifications, including further information or sharing information, will 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 relating to notifying a notifiable patient safety incident.

Section 34 provides, in respect of a notification made under Part 4 to a regulator, that the Freedom of Information Act 2014 will not apply to a record of or relating to that notification. Again, the purpose of these legislative protections, in line with international experience, is to encourage health services providers and health practitioners to comply with this requirement to notify the regulators of notifiable patient safety incidents without fear.

Part 5 addresses clinical audit. Section 35 deals with the interpretation for Part 5 and contains definitions of the terms "clinical audit", "clinical standard", "clinical guideline", "aggregated data" and "clinically-led". Section 36 provides detailed definitions of the terms “clinical audit” and “clinical guideline”. The definitions of “clinical audit”, “clinical standard” and “clinical guideline” are key to this Part in that a health services provider or a health practitioner who undertakes and publishes an audit may only seek protection from the Freedom of Information Act 2014 in respect of a clinical audit that has been conducted in accordance with the definitions in this Bill.

Section 37 details how a clinical audit to which this Part applies should be carried out. It should be collected solely for the purpose of improving patient safety and quality improvement, and published as aggregated information. Section 38 provides that a record of a clinical audit, a component of or information provided in respect of a clinical audit, to which this Part applies, is exempt from the Freedom of Information Act 2014. Section 39 contains legislative protections on clinical audits, in similar terms to sections 10 and 33.

Part 6 deals with the amendment of the Act of 2007 in order to extend HIQA's remit to the private hospital sector, a long overdue measure. Section 40 amends the definitions section of the Health Act 2007 to reflect the requirements of this Bill. Section 41 amends section 8 of the Health Act 2007 to allow for HIQA standards to apply to both public and private healthcare services. Section 42 deals with investigations by HIQA where the agency believes there is a serious risk to the health or welfare of people receiving a particular service. Investigations may be carried out by HIQA on its own initiative or where required by the Minister for Health or Minister for Children and Youth Affairs, as the case may be. This section amends section 9 of the 2007 Act to take account of the investigations into services provided by private healthcare providers.

Section 43 amends section 10 of the Health Act 2007 to enable HIQA to set standards for the private healthcare sector. Section 44 amends section 12 of the Health Act 2007 to include private healthcare providers as being among the bodies which HIQA may require to provide information or statistics in order to determine the level of compliance by these organisations with standards set by HIQA. Section 45 amends section 73 of the Health Act 2007 to also apply to premises owned, used or proposed to be used by a private hospital or a prescribed private health service. Section 46 amends section 78 of the Health Act 2007 so that HIQA may publish a report relating to the monitoring of compliance with standards by private hospitals. Section 47 provides that the Minister may prescribe, by regulation, a health service to be a prescribed private health service for the purposes of this legislation.

Section 48 repeals section 100 of the Health Act 2007, an aspect of the Act that has not proven to be necessary during the period of the Act's operation.

Part 7 addresses the offences and penalties. Section 49 sets out that a health services provider who fails to comply with the obligation to make an open disclosure of a notifiable patient safety incident, without reasonable excuse, shall be liable on summary conviction to a class A fine. A health services provider who fails to comply with the obligation to report a notifiable patient safety incident externally to the appropriate body will be liable on summary conviction to a class A fine. In many situations where patients are harmed, the error or mistake occurred because systems were not in place to support the healthcare practitioner or team in identifying and avoiding that error. For this reason, in this section the consequences for failing to comply with mandatory open disclosure and notification are placed on health services providers.

Part 8 deals with miscellaneous and general matters. Section 50 provides that the Minister for Health may publish guidelines on the operation of, and compliance with the Bill and regulations made under it. Section 51 provides that the Minister has the power to make regulations for any matters prescribed or to be prescribed in the Bill. Section 52 amends section 11 of the National Treasury Management Agency (Amendment) Act 2000 so the National Treasury Management Agency may provide the incident management system as the means of making the notification regarding a notifiable incident to the regulatory bodies.

Section 53 provides for the amendment of the Civil Liability (Amendment) Act 2017 in the manner specified in Schedule 2. Section 54 contains the savings and transitional provisions. Where a health services provider makes an open disclosure in accordance with Part 4 of the Civil Liability (Amendment) Act 2017 of an incident which would be a notifiable incident under this Bill before coming into operation of this legislation, Part 4 of the Act of 2017 shall continue to apply to that open disclosure.

In Schedule 1, Part 1 includes a list of 12 unintended or unanticipated notifiable patient safety incidents that are of a very serious nature and which mostly fall into the category of preventable incidents. In Schedule 1, Part 2 includes a notifiable incident for situations in which a baby is referred for therapeutic hypothermia. This is included as an indicator for neonatal conditions, for example. As outlined, under section 8, the Minister through regulations will have the power to designate, on an ongoing basis, additional incidents as notifiable patient safety incidents for which mandatory open disclosure is required. Schedule 2 deals with amendments to the Act of 2017. This Schedule details the amendments to the Civil Liability (Amendment) Act 2017, in order to align with this Bill.

In the time available I have endeavoured to take Members through as much of this very comprehensive Bill as I could. It deals with a number of important aspects of patient safety priorities, including mandatory open disclosure of serious notifiable patient safety incidents, external notification to the regulator, provisions regarding clinical audit, and for the first time the extension of HIQA's remit to the private healthcare system.

I am confident that the Bill will bring significant improvement in patient safety and quality. I commend the legislation to the House and I look forward to a detailed and robust scrutiny of the Bill, and hopefully its swift passage in coming weeks as we try to finally get this much-needed legislation on the Statute Book.

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