Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

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Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

2023 10

An Act to provide for the mandatory open disclosure, by health services providers of certain incidents occurring in the course of the provision, to a person, of a health service; to provide, in the interest of the common good, for certain restrictions on the use of the information provided in such disclosures that are made in accordance with this Act and of any apologies made in the course of such disclosures and the use of any other information relating to the open disclosure provided, and apology made, after the notifiable incident disclosure meeting; to provide for the mandatory open disclosure, by health services providers, of Part 5 reviews carried out in accordance with this Act; to provide, in the interest of the common good, for certain restrictions on the use of the information provided in such disclosures that are made in accordance with this Act and of any apologies made in the course of such disclosures and the use of any other information relating to the open disclosure provided, and apology made, after the Part 5 review disclosure meeting; to make provision for procedures in respect of clinical audit, and the data obtained in clinical audits; to provide for the notification of certain incidents to certain persons; to amend the National Treasury Management Agency (Amendment) Act 2000; to amend Part 4 of the Civil Liability (Amendment) Act 2017; to amend the Health Act 2007 to provide for the application of standards set by the Health Information and Quality Authority to private hospitals, to provide for 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 and for the Minister to prescribe certain health services as a prescribed private health service; and to provide for related matters.

[2 May 2023]

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S-1 Short title and commencement

1 Short title and commencement

(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.

S-2 Interpretation

2 Interpretation

(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 undersection 16, or

(b)

in the case of aPart 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 toparagraph (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 undersection 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 undersection 23, and

(b)

in relation to aPart 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 aPart 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 inparagraphs (a) to (f) of section 7(2), or a person nominated pursuant to section 7(3), or

(b)

aPart 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 aPart 5 review disclosure meeting,

(b)

“additional notifiable information provided”, or “apology made”, at an additional notifiable information meeting, or at an additionalPart 5 review meeting, or

(c)

information provided in a clarification undersection 23 or section 54, as the case may be,

includes information that is provided, or an...

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