Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

PART 1 Preliminary and General

1. Short title and commencement

1. (1) This Act may be cited as the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023.

(2) This Act shall come into operation on such day or days as the Minister may by order or orders appoint either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or different provisions.

2. Interpretation

2. (1) In this Act—

“Act of 1985” means the Dentists Act 1985;

“Act of 2000” means the National Treasury Management Agency (Amendment) Act 2000;

“Act of 2005” means the Health and Social Care Professionals Act 2005;

“Act of 2007” means the Health Act 2007;

“Act of 2011” means the Nurses and Midwives Act 2011;

“Act of 2014” means the Freedom of Information Act 2014;

“Act of 2017” means the Civil Liability (Amendment) Act 2017;

“additional notifiable information” shall be construed in accordance with section 21;

“additional notifiable information meeting” shall be construed in accordance with section 21;

“additional Part 5 review information” shall be construed in accordance with section 52;

“additional Part 5 review information meeting” shall be construed in accordance with section 52;

“agency contract” has the meaning assigned to it by section 7 of the Act of 2017;

“agency health practitioner” has the meaning assigned to it by section 7 of the Act of 2017;

“agency worker” has the meaning assigned to it by section 7 of the Act of 2017;

“apology”, in relation to an open disclosure of a notifiable incident, means an expression of sympathy or regret;

“Authority” means the Health Information and Quality Authority;

“cancer screening service” means—

(a) the service known as the national breast screening programme carried out by the National Cancer Screening Board and, since the dissolution of the Board on 1 April 2010, provided by the Executive,

(b) CervicalCheck, and

(c) the service known as the national colon cancer screening programme provided by the Executive,

and a reference in this Act to a cancer screening service includes any or all of the services specified in paragraph (a), (b) or (c);

“CervicalCheck” has the meaning assigned to it by the CervicalCheck Tribunal Act 2019;

“Commission” has the meaning assigned to it by the Mental Health Act 2001;

“designated person” means—

(a) in the case of a notifiable incident, the person designated under section 16, or

(b) in the case of a Part 5 review, the person designated under section 47;

“employee”, in relation to a health services provider has the meaning assigned to it by section 7 of the Act of 2017;

“employment agency” has the meaning assigned to it by section 7 of the Act of 2017;

“enactment” has the same meaning it has in the Interpretation Act 2005;

“Executive” means the Health Service Executive;

“fixed-term employee” has the same meaning it has in section 7 of the Act of 2017;

“health practitioner” means—

(a) a registered medical practitioner within the meaning of the Medical Practitioners Act 2007 or a medical practitioner practising medicine pursuant to section 50 of that Act,

(b) a registered dentist within the meaning of the Act of 1985,

(c) a registered pharmacist, or registered pharmaceutical assistant, within the meaning of the Pharmacy Act 2007,

(d) a registered nurse, or registered midwife, within the meaning of the Act of 2011,

(e) a registrant within the meaning of section 3 of the Act of 2005, or

(f) a person whose name is entered in the register referred to in Article 4(s) of the Order of 2000;

“health service” means the provision, by or under the direction of a health services provider, of clinical care or any ancillary service to a patient for—

(a) the screening (other than screening carried out by a cancer screening service), preservation or improvement of the health of the patient,

(b) the prevention, diagnosis, treatment or care of an illness, injury or health condition of the patient,

(c) the performance or surgery, or a surgical intervention, in respect of aesthetic purposes, or other non-medical purposes, that involves instruments or equipment being inserted into the body of the patient, or

(d) without prejudice to paragraph (a), a cancer screening service;

“health services provider” shall be construed in accordance with section 3;

“making an open disclosure of a notifiable incident” shall be construed in accordance with section 9;

“making an open disclosure of a Part 5 review” shall be construed in accordance with section 40;

“Minister” means the Minister for Health;

“notifiable incident” means an incident specified in—

(a) Schedule 1, or

(b) regulations made under section 8;

“notifiable incident disclosure meeting” shall be construed in accordance with section 18(1);

“open disclosure of a notifiable incident” shall be construed in accordance with section 9 and references to the open disclosure of a notifiable incident, or open disclosure in relation to a notifiable incident shall be construed accordingly;

“open disclosure of Part 5 review” shall be construed in accordance with section 40 and references to the open disclosure of Part 5 review, or open disclosure in relation to a Part 5 review shall be construed accordingly;

“other than in person”—

(a) in relation to a notifiable incident disclosure meeting, an additional information disclosure meeting or a clarification given under section 23, and

(b) in relation to a Part 5 disclosure meeting, an additional information disclosure meeting or a clarification given under section 54,

means holding such meeting or such clarification by means of the telephone or the internet (or other similar method of communication);

“Order of 2000” means the Pre-Hospital Emergency Care Council (Establishment) Order 2000 (S.I. No. 109 of 2000) amended by the Pre-Hospital Emergency Care Council (Establishment) Order 2000 (Amendment) Order 2004 (S.I. No. 575 of 2004);

“Part 5 review” means a review conducted in accordance with section 35 and includes—

(a) a request for a Part 5 review,

(b) the process undertaken by the health services provider to carry out the review, and

(c) the findings of the review;

“Part 5 review disclosure meeting” shall be construed in accordance with section 49(1);

“patient”, in relation to a health services provider, means a person to whom a health service is, or has been, provided;

“partnership”, in relation to the provision of a health service, means 2 or more health practitioners who provide a health service in common;

“prescribed” means prescribed in regulations made by the Minister under this Act;

“principal health practitioner”, in relation to a patient, means a health practitioner who has the principal clinical responsibility for the clinical care and treatment of the patient and, in the case of a cancer screening service, means the health practitioner who has the principal clinical responsibility for the cancer screening service;

“relevant person” means in relation to the making of an open disclosure of—

(a) a notifiable incident, a person specified in paragraphs (a) to (f) of section 7(2), or a person nominated pursuant to section 7(3), or

(b) a Part 5 review, a person specified in paragraphs (a) to (f) of section 39(2), or a person nominated pursuant to section 39(3);

“unintended”, in relation to a death, means a death arising from an unintended event occurring, or arising from, the provision of a health service.

(2) References in this Act to—

(a) “information provided” or “an apology made” at a notifiable incident disclosure meeting or a Part 5 review disclosure meeting,

(b) “additional notifiable information provided”, or “apology made”, at an additional notifiable information meeting, or at an additional Part 5 review meeting, or

(c) information provided in a clarification under section 23 or section 54, as the case may be,

includes information that is provided, or an apology that is made, orally or in writing.

3. Health services provider

3. (1) In this Act, “health services provider” means—

(a) a person, other than a health practitioner, who provides one or more health services and for that purpose—

(i) employs a health practitioner for the provision (whether for, or on behalf of, that person) by that practitioner, of a health service,

(ii) enters into a contract for services with a health practitioner for the provision (whether for, or on behalf of, that person) by that health practitioner of a health service,

(iii) enters into an agency contract for the assignment, by an employment agency, of an agency health practitioner to provide a health service for, or on behalf of, that person,

(iv) enters into an arrangement with a health practitioner—

(I) for the provision by that health practitioner of a health service (whether for, or on behalf of, that person, or through or in connection with that person),

(II) for the provision by that health practitioner of a health service on his or her own behalf (whether through or in connection with, or by or on behalf of, that person or otherwise), or

(III) without prejudice to the generality of clause (II), to provide that health practitioner with privileges commonly known as practising privileges (whether such privileges are to operate through or in connection with, or by or on behalf of, the person or otherwise),

or

(v) insofar as it relates to the carrying on of the business of providing a health service—

(I) employs one or more persons,

(II) enters into a contract for services with one or more persons,

(III) enters into an agency contract for the assignment of an agency worker, or

(IV) enters into an arrangement with one or more persons,

in respect of the carrying on of that business,

(b) a health practitioner who provides a health service and does not provide that health service for, or on behalf of, or through or in connection with (whether by reason of employment or otherwise), a person referred to in paragraph (a) and includes a health practitioner who—

(i) employs another health practitioner for the provision (whether for, or on behalf of, the first-mentioned health practitioner) by that other health practitioner of a health service,

(ii) enters into a contract for services with another health practitioner for the provision (whether for, or on behalf of, the first-mentioned health practitioner) by that other health practitioner, of a health service,

(iii) enters into an agency contract for the assignment, by an employment agency, of an agency health practitioner to provide a health service for, or on behalf of, the first-mentioned health practitioner, or

(iv) insofar as it relates to the carrying on of the business of providing a health service—

(I) employs one or more persons,

(II) enters into a contract for services with one or more persons,

(III) enters into an agency contract for the assignment of an agency worker, or

(IV) enters into an arrangement with one or more persons,

in respect of the carrying on of that business,

(c) a partnership of 2 or more health practitioners who provide a health service in common which does not provide that health service for, or on behalf of, or through or in connection with (whether by reason of employment or otherwise), a person referred to in paragraph (a) and includes a partnership which—

(i) employs another health practitioner for the provision (whether by or on behalf of, the partnership) by that other health practitioner of a health service,

(ii) enters into a contract for services with another health practitioner for the provision (whether for, or on behalf of, the partnership) by that other health practitioner of a health service,

(iii) enters into an agency contract for the assignment, by an employment agency, of an agency health practitioner to provide a health service for, or on behalf of, the partnership, or

(iv) insofar as it relates to the carrying on of the business of providing a health service—

(I) employs one or more persons,

(II) enters into a contract for services with one or more persons,

(III) enters into an agency contract for the assignment of an agency worker, or

(IV) enters into an arrangement with one or more persons,

in respect of the carrying on of that business, or

(d) in the case of a cancer screening service, the Executive or, in respect of the cancer screening service referred to in paragraph (b) of the definition of “cancer screening service”, a provider referred to in paragraph (b) or (c).

(2) For the purposes of paragraphs (b) and (c) of the definition of “health services provider”, references in each such paragraph to “through or in connection with” do not include the use by a health services provider referred to in each such paragraph of a health service (or processes related to a health service) provided—

(a) by a health services provider referred to in paragraph (a) of that definition, and

(b) for the purpose of the provision, by a health services provider—

(i) referred to in paragraph (b) of that definition, of a health service on its own behalf, or

(ii) referred to in paragraph (c) of that definition, of a health service on behalf of a partnership.

4. Expenses

4. The expenses incurred by the Minister in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Public Expenditure, National Development Plan Delivery and Reform, be paid out of monies provided by the Oireachtas.

PART 2 Open Disclosure of Notifiable Incident

Chapter 1

5. Obligation to make an open disclosure of notifiable incident

5. (1) Where a health services provider is satisfied that a notifiable incident has occurred in the course of the provision by it of a health service to a patient, (whether the notifiable incident occurred when that provider was providing that service or another health services provider was providing a health service to that patient) the health services provider shall, subject to sections 19 and 20, hold a notifiable incident disclosure meeting in order to make the open disclosure of that notifiable incident to the patient or relevant person (or both of them) as specified in section 7.

(2) For the purposes of subsection (1), where a health services provider is satisfied that a notifiable incident has occurred but—

(a) none, or not all, of the likely consequences of the notifiable incident have presented or developed, or

(b) not all of the information relating to the incident, including information relating to the cause of the incident, is available,

the health services provider shall make the open disclosure of the notifiable incident under subsection (1) notwithstanding the absence of some or all of those consequences or that information.

(3) For the purposes of subsection (1), a health services provider may be satisfied that a notifiable incident has occurred as referred to in that subsection whether the provider has received information in respect of that notifiable incident pursuant to section 6 or otherwise.

6. Health practitioner to inform health services provider of notifiable incident

6. (1) Without prejudice to section 5, where, in the opinion of a health practitioner a notifiable incident has occurred in relation to a patient, the health practitioner shall, as soon as practicable, inform the health services provider which is, at the time he or she has formed the opinion, providing the health service to the patient.

(2) A health practitioner shall inform the health services provider referred to in subsection (1) whether—

(a) the notifiable incident may have occurred during the provision of a health service to the patient by—

(i) that provider, or

(ii) another health services provider,

or

(b) he or she is unsure when the notifiable incident occurred.

7. Persons to whom open disclosure of notifiable incident is made

7. (1) A health services provider shall make the open disclosure of the notifiable incident to—

(a) the patient concerned,

(b) a relevant person where—

(i) in the opinion of the principal health practitioner providing clinical care to the patient, having regard to the clinical circumstances of the patient, who is the subject of the notifiable incident, the capacity of the patient is such that he or she is unable to—

(I) participate in that open disclosure, and

(II) consent to that open disclosure being made to a relevant person,

and that capacity is unlikely to be of a temporary duration, and the health services provider is satisfied that a notifiable incident has occurred, it is appropriate, having regard to section 5, that the open disclosure of that incident is made to a relevant person,

(ii) the patient has died, or

(iii) the patient has requested the health services provider to make the open disclosure of the notifiable incident to a person whom the patient has nominated as a relevant person for the purposes of this Act and not the patient,

or

(c) both the patient and a relevant person where, before the notifiable incident disclosure meeting is held, the patient has requested that a person whom the patient has nominated as a relevant person for the purposes of this Act attends that meeting to assist the patient and that in addition to making the open disclosure to the patient that the health services provider makes the open disclosure of the notifiable incident to that relevant person.

(2) For the purposes of subsection (1)(b)(i), and making an open disclosure of a notifiable incident to a relevant person, the health services provider shall make the open disclosure—

(a) where an appointment has been made under Part 3, 4, 5, 7 or 8 of the Assisted Decision-Making (Capacity) Act 2015 in relation to health matters, to the person appointed,

(b) where the patient has, under the Powers of Attorney Act 1996, made an enduring power of attorney (within the meaning of that Act) which includes a personal care decision (within the meaning of that Act), to the attorney appointed pursuant to that Act,

(c) where the patient is a ward of court, to the Committee of the Person of that ward, duly authorised in that behalf,

(d) where the patient has nominated, in writing, a person to whom his or her clinical information may be disclosed, to that person,