PATIENT SAFETY (NOTIFIABLE INCIDENTS AND OPEN DISCLOSURE) ACT 2023

SCHEDULE 1 Notifiable Incidents

SCHEDULE 1

Notifiable Incidents

Section 2

Part 1

Part 1

Item

Item

Notifiable Incident

Notifiable Incident

1.1

1.1

Surgery performed on the wrong patient resulting in unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.

Surgery performed on the wrong patient resulting in unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.

1.2

1.2

Surgery performed on the wrong site resulting in unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.

Surgery performed on the wrong site resulting in unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.

1.3

1.3

Wrong surgical procedure performed on a patient resulting in an unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.

Wrong surgical procedure performed on a patient resulting in an unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.

1.4

1.4

Unintended retention of a foreign object in a patient after surgery resulting in an unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.

Unintended retention of a foreign object in a patient after surgery resulting in an unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.

1.5

1.5

Any unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery in any place or premises in which a health services provider provides a health service where the death is directly related to a surgical operation or anaesthesia (including recovery from the effects of anaesthesia) and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

Any unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery in any place or premises in which a health services provider provides a health service where the death is directly related to a surgical operation or anaesthesia (including recovery from the effects of anaesthesia) and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

1.6

1.6

Any unintended and unanticipated death occurring in any place or premises in which a health services provider provides a health service that is directly related to any medical treatment and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

Any unintended and unanticipated death occurring in any place or premises in which a health services provider provides a health service that is directly related to any medical treatment and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

1.7

1.7

Patient death due to transfusion of ABO incompatible blood or blood components and the death was unintended and unanticipated and which did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

Patient death due to transfusion of ABO incompatible blood or blood components and the death was unintended and unanticipated and which did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

1.8

1.8

Patient death associated with a medication error and the death was unintended and unanticipated as it did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

Patient death associated with a medication error and the death was unintended and unanticipated as it did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

1.9

1.9

An unanticipated death of a woman while pregnant or within 42 days of the end of the pregnancy from any cause related to, or aggravated by, the management of the pregnancy, and which did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

An unanticipated death of a woman while pregnant or within 42 days of the end of the pregnancy from any cause related to, or aggravated by, the management of the pregnancy, and which did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient.

1.10

1.10

An unanticipated and unintended stillborn child where the child was born without a fatal foetal abnormality and with a prescribed birthweight or has achieved a prescribed gestational age and who shows no sign of life at birth, from any cause related to or aggravated by the management of the pregnancy, and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the child.

An unanticipated and unintended stillborn child where the child was born without a fatal foetal abnormality and with a prescribed birthweight or has achieved a prescribed gestational age and who shows no sign of life at birth, from any cause related to or aggravated by the management of the pregnancy, and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the child.

1.11

1.11

An unanticipated and unintended perinatal death where a child born with, or having achieved, a prescribed gestational age and a prescribed birthweight who was alive at the onset of care in labour, from any cause related to, or aggravated by, the management of the pregnancy, and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the child or an underlying condition of the child.

An unanticipated and unintended perinatal death where a child born with, or having achieved, a prescribed gestational age and a prescribed birthweight who was alive at the onset of care in labour, from any cause related to, or aggravated by, the management of the pregnancy, and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the child or an underlying condition of the child.

1.12

1.12

An unintended death where the cause is believed to be the suicide of a patient while being cared for in or at a place or premises in which a health services provider provides a health service whether or not the death was anticipated or arose from, or was wholly or partially attributable to, the illness or underlying condition of the patient.

An unintended death where the cause is believed to be the suicide of a patient while being cared for in or at a place or premises in which a health services provider provides a health service whether or not the death was anticipated or arose from, or was wholly or partially attributable to, the illness or underlying condition of the patient.

Part 2

Part 2

Item

Item

Notifiable Incident

Notifiable Incident

2.1

2.1

A baby who— (a) in the clinical judgment of the treating health practitioner requires, or is referred for, therapeutic hypothermia, or (b) has been considered for, but did not undergo therapeutic hypothermia as, in the clinical judgment of the health practitioner, such therapy was contraindicated due to the severity of the presenting condition.

A baby who—

(a) in the clinical judgment of the treating health practitioner requires, or is referred for, therapeutic hypothermia, or

(b) has been considered for, but did not undergo therapeutic hypothermia as, in the clinical judgment of the health practitioner, such therapy was contraindicated due to the severity of the presenting condition.

SCHEDULE 2 Amendments of Act of 2017

SCHEDULE 2

Amendments of Act of 2017

Section 82

Item

Item

Provision of Act of 2017

Provision of Act of 2017

Amendment to provision of Act of 2017

Amendment to provision of Act of 2017

1.

1.

Section 7(1)

Section 7(1)

The deletion of the definition of “Act of 2010”.

The deletion of the definition of “Act of 2010”.

2.

2.

Section 7(1)

Section 7(1)

The substitution for the definition of “relevant person” of the following definition: “‘relevant person’ means— (a) a person specified in paragraphs (a) to (f) of section 12A(1), or (b) a person nominated pursuant to section 12A(2);”.

The substitution for the definition of “relevant person” of the following definition

“‘relevant person’ means—

(a) a person specified in paragraphs (a) to (f) of section 12A(1), or

(b) a person nominated pursuant to section 12A(2);”.

3.

3.

Section 7(1)

Section 7(1)

The insertion of the following definitions

The insertion of the following definitions

“‘notifiable incident’ has the meaning assigned to it by the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023;

“‘notifiable incident’ has the meaning assigned to it by the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023;

‘other than in person’, in relation to an open disclosure meeting, an additional information meeting or a clarification given under section 19, means holding such meeting or such clarification by means of the telephone or the internet (or other similar method of communication);”.

‘other than in person’, in relation to an open disclosure meeting, an additional information meeting or a clarification given under section 19, means holding such meeting or such clarification by means of the telephone or the internet (or other similar method of communication);”.

4.

4.

Section 8(a)

Section 8(a)

The insertion of “, other than a notifiable incident,” after “an incident”.

The insertion of “, other than a notifiable incident,” after “an incident”.

5.

5.

Section 8(b)

Section 8(b)

The insertion of “, other than a notifiable incident,” after “an incident”.

The insertion of “, other than a notifiable incident,” after “an incident”.

6.

6.

New section 9A inserted

New section 9A inserted

The insertion of the following new section after section 9: “Disclosure of information by health services provider and health practitioner 9A. (1) When making an open disclosure of a patient safety incident under this Act, a health services provider shall provide all relevant information in relation to the provision of a health service to the patient (or relevant person as the case may be) that is being provided by that provider to the patient and where appropriate any other health service that is to be, or may be provided to address the consequences of that incident.

The insertion of the following new section after section 9

“Disclosure of information by health services provider and health practitioner

9A. (1) When making an open disclosure of a patient safety incident under this Act, a health services provider shall provide all relevant information in relation to the provision of a health service to the patient (or relevant person as the case may be) that is being provided by that provider to the patient and where appropriate any other health service that is to be, or may be provided to address the consequences of that incident.

(2) When making an open disclosure of a patient safety incident under this Act, a health practitioner shall provide all relevant information in relation to the provision of a health service to the patient (or relevant person as the case may be) that is being provided by that provider to the patient and where appropriate any other health service that is to be, or may be provided to address the consequences of that incident.”.

(2) When making an open disclosure of a patient safety incident under this Act, a health practitioner shall provide all relevant information in relation to the provision of a health service to the patient (or relevant person as the case may be) that is being provided by that provider to the patient and where appropriate any other health service that is to be, or may be provided to address the consequences of that incident.”.

7.

7.

Section 12(b)

Section 12(b)

The substitution of the following paragraph for paragraph (b): “(b) a relevant person where—

The substitution of the following paragraph for paragraph (b)

“(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 patient safety incident, the capacity of the patient is such that he or she is unable to—

(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 patient safety 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,

(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 patient safety incident has occurred, it is appropriate the open disclosure of that incident is 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 patient safety incident has occurred, it is appropriate 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 patient safety incident to a person whom the patient has nominated as a relevant person for the purposes of this Part and not the patient, or”.

(ii) the patient has died, or

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

8.

8.

Section 12(c)

Section 12(c)

The substitution of the following paragraph for paragraph (c): “(c) both the patient and a relevant person where, before the open 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 Part, 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 patient safety incident to that relevant person.”.

The substitution of the following paragraph for paragraph (c)

“(c) both the patient and a relevant person where, before the open 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 Part, 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 patient safety incident to that relevant person.”.

9.

9.

New section 12A inserted

New section 12A inserted

By the insertion of the following new section after section 12: “Section 12: supplemental provisions 12A. (1) For the purposes of section 12(b)(i), and making an open disclosure of a patient safety incident to a relevant person, the health services provider shall make the open disclosure—

By the insertion of the following new section after section 12

“Section 12: supplemental provisions

12A. (1) For the purposes of section 12(b)(i), and making an open disclosure of a patient safety 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,

(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,

(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,

(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,

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

(e) where the patient is a child, to the parent or guardian of that child or where—

(e) where the patient is a child, to the parent or guardian of that child or where—

(i) an order in respect of the child made under section 18 of the Act of 1991, (ii) the child has been taken into the care of the Agency under section 4 of the Act of 1991, or (iii) an order in respect of the child has been made under section 13, 17 or 20 of the Act of 1991,

(i) an order in respect of the child made under section 18 of the Act of 1991,

(ii) the child has been taken into the care of the Agency under section 4 of the Act of 1991, or

(iii) an order in respect of the child has been made under section 13, 17 or 20 of the Act of 1991,

to the parents or guardian of the child and the Child and Family Agency (or an authorised person) or where an order under section 23H of the Act of 1991 has been made in respect of the child to the parents or guardian of the child and that Agency (or the social worker assigned responsibility for the child by the Agency), or

to the parents or guardian of the child and the Child and Family Agency (or an authorised person) or where an order under section 23H of the Act of 1991 has been made in respect of the child to the parents or guardian of the child and that Agency (or the social worker assigned responsibility for the child by the Agency), or

(f) where the patient does not fall within the categories specified in paragraphs (a) to (e), to—

(f) where the patient does not fall within the categories specified in paragraphs (a) to (e), to—

(i) the spouse, civil partner or cohabitant of the patient, (ii) an adult son or daughter of the patient, or (iii) the mother, father, brother or sister of the patient.

(i) the spouse, civil partner or cohabitant of the patient,

(ii) an adult son or daughter of the patient, or

(iii) the mother, father, brother or sister of the patient.

(2) For the purposes of a request referred to in— (a) section 12(b)(iii), and (b) section 12(c),

(2) For the purposes of a request referred to in—

(a) section 12(b)(iii), and

(b) section 12(c),

without prejudice to subsection (1)(d), where a patient makes a request referred to in paragraph (a) or (b), the patient shall nominate the person in writing (including a person referred to in subsection (1)) as a person to whom clinical information may be disclosed in respect of information to be provided in an open disclosure of a patient safety incident.

without prejudice to subsection (1)(d), where a patient makes a request referred to in paragraph (a) or (b), the patient shall nominate the person in writing (including a person referred to in subsection (1)) as a person to whom clinical information may be disclosed in respect of information to be provided in an open disclosure of a patient safety incident.

(3) For the purposes of section 12(b)(ii), and making an open disclosure of a patient safety incident, the open disclosure shall be made to a person specified in subsection (1).

(3) For the purposes of section 12(b)(ii), and making an open disclosure of a patient safety incident, the open disclosure shall be made to a person specified in subsection (1).

(4) Where an open disclosure of a patient safety incident is made pursuant to— (a) section 12(b)(i) or (b)(iii), to a relevant person, or (b) section 12(c), to both the patient and the relevant person,

(4) Where an open disclosure of a patient safety incident is made pursuant to—

(a) section 12(b)(i) or (b)(iii), to a relevant person, or

(b) section 12(c), to both the patient and the relevant person,

the relevant person shall consult with the patient in respect of the information provided at the open disclosure meeting, and shall convey, to the health services provider with the consent of the patient, the instructions, preferences and wishes of the patient in respect of any matter arising from that information.

the relevant person shall consult with the patient in respect of the information provided at the open disclosure meeting, and shall convey, to the health services provider with the consent of the patient, the instructions, preferences and wishes of the patient in respect of any matter arising from that information.

(5) Where, after a health services provider has, in accordance with section 12(b)(i), held the open disclosure meeting with the relevant person and after that meeting was held the patient regains capacity, the health services provider shall inform the patient that such meeting was held with the relevant person and shall provide the patient with the information given at that meeting.

(5) Where, after a health services provider has, in accordance with section 12(b)(i), held the open disclosure meeting with the relevant person and after that meeting was held the patient regains capacity, the health services provider shall inform the patient that such meeting was held with the relevant person and shall provide the patient with the information given at that meeting.

(6) In this section— ‘Act of 1991’ means the Child Care Act 1991; ‘authorised person’ in relation to a child referred to in subsection (1)(e) who is—

(6) In this section—

‘Act of 1991’ means the Child Care Act 1991;

‘authorised person’ in relation to a child referred to in subsection (1)(e) who is—

(a) placed in residential care pursuant to the Act of 1991, has the same meaning as it has in the Child Care (Placement of Children in Residential Care) Regulations 1995 (S.I. No. 259 of 1995), (b) placed in foster care pursuant to the Act of 1991, has the same meaning as it has in the Child Care (Placement of Children in Foster Care) Regulations 1995 (S.I. No. 260 of 1995), or (c) placed with a relative pursuant to the Act of 1991, has the same meaning as it has in the Child Care (Placement of Children with Relatives) Regulations 1995 (S.I. No. 261 of 1995);

(a) placed in residential care pursuant to the Act of 1991, has the same meaning as it has in the Child Care (Placement of Children in Residential Care) Regulations 1995 (S.I. No. 259 of 1995),

(b) placed in foster care pursuant to the Act of 1991, has the same meaning as it has in the Child Care (Placement of Children in Foster Care) Regulations 1995 (S.I. No. 260 of 1995), or

(c) placed with a relative pursuant to the Act of 1991, has the same meaning as it has in the Child Care (Placement of Children with Relatives) Regulations 1995 (S.I. No. 261 of 1995);

‘civil partner’ has the meaning assigned to it by the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010; ‘cohabitant’ means one of 2 adults (whether of the same or opposite sex) who live together as a couple in an intimate and committed relationship and who are not married to each other or civil partners of each other.”.

‘civil partner’ has the meaning assigned to it by the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010;

‘cohabitant’ means one of 2 adults (whether of the same or opposite sex) who live together as a couple in an intimate and committed relationship and who are not married to each other or civil partners of each other.”.

10.

10.

Section 15(1)(f)

Section 15(1)(f)

By the substitution for paragraph (f) of the following paragraph

By the substitution for paragraph (f) of the following paragraph

“(f) having regard to the information available, make arrangements for the preparation of the statement referred to in section 16(5), that is to be provided, in accordance with section 16(2)(c) to the patient or relevant person (or both of them).”.

“(f) having regard to the information available, make arrangements for the preparation of the statement referred to in section 16(5), that is to be provided, in accordance with section 16(2)(c) to the patient or relevant person (or both of them).”.

11.

11.

Section 15A (inserted by section 82 of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023)

Section 15A

(inserted by section 82 of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023)

By the insertion of the following section after section 15: “Open disclosure meeting generally to be held in person 15A. (1) An open disclosure meeting shall, subject to subsection (2), be held in person with the patient or relevant person (or both of them).

By the insertion of the following section after section 15

“Open disclosure meeting generally to be held in person

15A. (1) An open disclosure meeting shall, subject to subsection (2), be held in person with the patient or relevant person (or both of them).

(2) A patient or relevant person (or both of them) may, when contacted by a health services provider pursuant to section 16 to make arrangements to meet with it for the purpose of making an open disclosure, request the provider that the proposed meeting be held other than in person.

(2) A patient or relevant person (or both of them) may, when contacted by a health services provider pursuant to section 16 to make arrangements to meet with it for the purpose of making an open disclosure, request the provider that the proposed meeting be held other than in person.

(3) A request under subsection (2) may be made orally.

(3) A request under subsection (2) may be made orally.

(4) Where a request under subsection (2) is made orally, the health services provider shall make a record of the request in writing and maintain it with the records referred to in section 21.”.

(4) Where a request under subsection (2) is made orally, the health services provider shall make a record of the request in writing and maintain it with the records referred to in section 21.”.

12.

12.

Section 16(1)(b)

Section 16(1)(b)

To substitute the following paragraph for paragraph (b)

To substitute the following paragraph for paragraph (b)

“(b) where a patient or a relevant person has (or both of them have) made a request under section 15A, to hold the meeting other than in person,”.

“(b) where a patient or a relevant person has (or both of them have) made a request under section 15A, to hold the meeting other than in person,”.

13.

13.

Section 16(2)(c)

Section 16(2)(c)

To substitute the following paragraph for paragraph (c)

To substitute the following paragraph for paragraph (c)

“(c) shall, in accordance with section 20A, give the patient or the relevant person (or both of them) a copy of the statement referred to in subsection (5), and”.

“(c) shall, in accordance with section 20A, give the patient or the relevant person (or both of them) a copy of the statement referred to in subsection (5), and”.

14.

14.

Section 16(2)(d)

Section 16(2)(d)

To substitute the following paragraph for paragraph (d)

To substitute the following paragraph for paragraph (d)

“(d) shall give the statement referred to in section 11(1) to the patient or relevant person (or both of them) in accordance with section 20A or, in the case of a meeting referred to in subsection (1)(b), shall give that statement to the patient or relevant person (or both of them) in accordance with section 20A.”.

“(d) shall give the statement referred to in section 11(1) to the patient or relevant person (or both of them) in accordance with section 20A or, in the case of a meeting referred to in subsection (1)(b), shall give that statement to the patient or relevant person (or both of them) in accordance with section 20A.”.

15.

15.

Section 16(5)(a)

Section 16(5)(a)

To delete paragraph (a).

To delete paragraph (a).

16.

16.

Section 17(1)

Section 17(1)

The substitution for subsection (1) of the following subsection: “(1) Nothing in this Part shall require a patient to engage with the health services provider in the open disclosure of a patient safety incident and—

The substitution for subsection (1) of the following subsection

“(1) Nothing in this Part shall require a patient to engage with the health services provider in the open disclosure of a patient safety incident and—

(a) a patient may authorise a relevant person not to attend the open disclosure meeting, and

(a) a patient may authorise a relevant person not to attend the open disclosure meeting, and

(b) where a relevant person refuses to attend the open disclosure meeting, the health services provider shall inform the patient of the refusal and the patient may specify another relevant person to attend that meeting.”.

(b) where a relevant person refuses to attend the open disclosure meeting, the health services provider shall inform the patient of the refusal and the patient may specify another relevant person to attend that meeting.”.

17.

17.

Section 17(3)(a)

Section 17(3)(a)

In section 17(3), in paragraph (a), to delete “, in the prescribed form,”.

In section 17(3), in paragraph (a), to delete “, in the prescribed form,”.

18.

18.

Section 17(3) new paragraph inserted

Section 17(3) new paragraph inserted

In section 17(3), to insert the following paragraph after paragraph (a)

In section 17(3), to insert the following paragraph after paragraph (a)

“(aa) include, in the statement referred to in paragraph (a), a reference to the entitlement under subsection (7) for the patient to make a later request for an open disclosure meeting despite the refusal referred to in subsection (2),”.

“(aa) include, in the statement referred to in paragraph (a), a reference to the entitlement under subsection (7) for the patient to make a later request for an open disclosure meeting despite the refusal referred to in subsection (2),”.

19.

19.

Section 17(5)(a)

Section 17(5)(a)

In section 17(5), in paragraph (a), to delete “, in the prescribed form,”.

In section 17(5), in paragraph (a), to delete “, in the prescribed form,”.

20.

20.

Section 17(5) new paragraph inserted

Section 17(5) new paragraph inserted

To insert the following new paragraph after paragraph (a)

To insert the following new paragraph after paragraph (a)

“(aa) include, in the statement referred to in paragraph (a), a reference to the entitlement under subsection (7) for the patient to make a later request for an open disclosure meeting despite the refusal referred to in subsection (4),”.

“(aa) include, in the statement referred to in paragraph (a), a reference to the entitlement under subsection (7) for the patient to make a later request for an open disclosure meeting despite the refusal referred to in subsection (4),”.

21.

21.

Section 17(6)(i)

Section 17(6)(i)

In section 17(6), in paragraph (i), to delete “, in the prescribed form,”.

In section 17(6), in paragraph (i), to delete “, in the prescribed form,”.

22.

22.

Section 17(6)

Section 17(6)

In section 17(6), after paragraph (i), to insert the following new paragraph

In section 17(6), after paragraph (i), to insert the following new paragraph

“(ia) include, in the note referred to in paragraph (i), the incident to be disclosed and the date of the incident (if known),”.

“(ia) include, in the note referred to in paragraph (i), the incident to be disclosed and the date of the incident (if known),”.

23.

23.

Section 17(6)(iii)

Section 17(6)(iii)

In section 17(6), in paragraph (iii), to substitute “paragraph” for “subparagraph” in each place where it occurs.

In section 17(6), in paragraph (iii), to substitute “paragraph” for “subparagraph” in each place where it occurs.

24.

24.

Section 17 new subsections inserted

Section 17 new subsections inserted

In section 17, to insert the following new subsections after subsection (6)

In section 17, to insert the following new subsections after subsection (6)

“(7) Where a patient or a relevant person has, or, as the case may be, both of them have, refused to engage with the health services provider in the making of an open disclosure of a patient safety incident, the patient may, within 5 years from the date of the refusal, request the health services provider to make the open disclosure.

“(7) Where a patient or a relevant person has, or, as the case may be, both of them have, refused to engage with the health services provider in the making of an open disclosure of a patient safety incident, the patient may, within 5 years from the date of the refusal, request the health services provider to make the open disclosure.

(8) A request referred to in subsection (7) may be made orally and the provider shall keep a note of the request in writing specifying the date of the request and the person who made it.

(8) A request referred to in subsection (7) may be made orally and the provider shall keep a note of the request in writing specifying the date of the request and the person who made it.

(9) Where the health services provider receives a request under subsection (7), it shall hold an open disclosure meeting.

(9) Where the health services provider receives a request under subsection (7), it shall hold an open disclosure meeting.

(10) The health services provider shall keep, in the records referred to in section 21, the note referred to in subsection (8).”.

(10) The health services provider shall keep, in the records referred to in section 21, the note referred to in subsection (8).”.

25.

25.

Section 18 new subsections inserted

Section 18 new subsections inserted

In section 18, to insert the following subsections after subsection (1)

In section 18, to insert the following subsections after subsection (1)

“(1A) An additional information meeting shall, subject to subsection (1B), be held in person with the patient or relevant person (or both of them).

“(1A) An additional information meeting shall, subject to subsection (1B), be held in person with the patient or relevant person (or both of them).

(1B) A patient or a relevant person (or both of them) may, when requesting the holding of an additional information meeting, request the provider that the proposed meeting be held other than in person.

(1B) A patient or a relevant person (or both of them) may, when requesting the holding of an additional information meeting, request the provider that the proposed meeting be held other than in person.

(1C) A request under subsection (1B) shall be made orally.

(1C) A request under subsection (1B) shall be made orally.

(1D) Where a request is made orally under subsection (1C), the health services provider shall make a note, in writing, of the request and it shall be kept in the records referred to in section 21.”.

(1D) Where a request is made orally under subsection (1C), the health services provider shall make a note, in writing, of the request and it shall be kept in the records referred to in section 21.”.

26.

26.

Section 18(3)(b)

Section 18(3)(b)

In section 18(3), to substitute the following paragraph for paragraph (b)

In section 18(3), to substitute the following paragraph for paragraph (b)

“(b) where the patient or relevant person has made a request under subsection (1B), to hold the meeting other than in person,”.

“(b) where the patient or relevant person has made a request under subsection (1B), to hold the meeting other than in person,”.

27.

27.

Section 18(4)

Section 18(4)

In section 18(4), to substitute the following paragraph for paragraph (c)

In section 18(4), to substitute the following paragraph for paragraph (c)

“(c) shall, in accordance with section 20A, give the patient or the relevant person (or both of them) a copy of the statement referred to in subsection (6).”.

“(c) shall, in accordance with section 20A, give the patient or the relevant person (or both of them) a copy of the statement referred to in subsection (6).”.

28.

28.

Section 18(6)(a)

Section 18(6)(a)

In section 18(6), to substitute the following paragraph for paragraph (a)

In section 18(6), to substitute the following paragraph for paragraph (a)

“(a) be in writing,”.

“(a) be in writing,”.

29.

29.

Section 19(1)

Section 19(1)

Section 19(1) is amended by the substitution of the following for paragraph (b)

Section 19(1) is amended by the substitution of the following for paragraph (b)

“(b) any additional information provided to the patient or relevant person (or both of them) at the additional information meeting,

“(b) any additional information provided to the patient or relevant person (or both of them) at the additional information meeting,

and may request that the clarification be made other than in person.”.

and may request that the clarification be made other than in person.”.

30.

30.

Section 19(2)(e)(i)

Section 19(2)(e)(i)

In section 19(2), in paragraph (e)(i), to delete “, in the prescribed form”.

In section 19(2), in paragraph (e)(i), to delete “, in the prescribed form”.

31.

31.

Section 19(2)(e)(i)(I)

Section 19(2)(e)(i)(I)

In section 19(2), in paragraph (e)(i), in clause (I), after “subsection (1)” to insert “and whether it was requested that the clarification be made other than in person”.

In section 19(2), in paragraph (e)(i), in clause (I), after “subsection (1)” to insert “and whether it was requested that the clarification be made other than in person”.

32.

32.

Section 19(3)(b)

Section 19(3)(b)

In section 19(3), in paragraph (b), to substitute “shall, in accordance with section 20A, give” for “shall give”.

In section 19(3), in paragraph (b), to substitute “shall, in accordance with section 20A, give” for “shall give”.

33.

33.

Section 19(5)(a)

Section 19(5)(a)

Section 19(5) is amended by the deletion of paragraph (a).

Section 19(5) is amended by the deletion of paragraph (a).

34.

34.

Section 20(4)(a)

Section 20(4)(a)

In section 20(4), in paragraph (a), to delete “in the prescribed form,”.

In section 20(4), in paragraph (a), to delete “in the prescribed form,”.

35.

35.

Section 20 new subsection inserted

Section 20 new subsection inserted

To insert the following subsection after subsection (4)

To insert the following subsection after subsection (4)

“(4A) Where, at any time after the signing of the statement referred to in subsection (4)—

“(4A) Where, at any time after the signing of the statement referred to in subsection (4)—

(a) the health services provider makes contact with the patient or the relevant person, or, as the case may be, both of them, or

(a) the health services provider makes contact with the patient or the relevant person, or, as the case may be, both of them, or

(b) the patient or relevant person makes, or, as the case may be, both of them make, contact with the health services provider,

(b) the patient or relevant person makes, or, as the case may be, both of them make, contact with the health services provider,

the health services provider shall hold an open disclosure meeting in order to make the open disclosure of the patient safety incident after that contact has been made.”.

the health services provider shall hold an open disclosure meeting in order to make the open disclosure of the patient safety incident after that contact has been made.”.

36.

36.

Section 20A (inserted by section 82 of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023)

Section 20A (inserted by section 82 of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023)

By the insertion of the following section after section 20

By the insertion of the following section after section 20

“Statements specifying information given at certain meetings 20A. (1) Subsection (2) shall apply for the purposes of—

“Statements specifying information given at certain meetings

20A. (1) Subsection (2) shall apply for the purposes of—

(a) an open disclosure meeting that is held in person and the provision of the statement referred to in section 16(5) to a patient or relevant person (or both of them) in accordance with section 16(2)(c) and the statement referred to in section 16(2)(d),

(a) an open disclosure meeting that is held in person and the provision of the statement referred to in section 16(5) to a patient or relevant person (or both of them) in accordance with section 16(2)(c) and the statement referred to in section 16(2)(d),

(b) an additional information meeting that is held in person and the provision of the statement referred to in section 18(6) to a patient or relevant person (or both of them) in accordance with section 18(4), and

(b) an additional information meeting that is held in person and the provision of the statement referred to in section 18(6) to a patient or relevant person (or both of them) in accordance with section 18(4), and

(c) a clarification provided under section 19 and the provision of the statement referred to in section 19(3)(b) to a patient or relevant person (or both of them) in accordance with that section.

(c) a clarification provided under section 19 and the provision of the statement referred to in section 19(3)(b) to a patient or relevant person (or both of them) in accordance with that section.

(2) A health services provider shall—

(2) A health services provider shall—

(a) give the statements referred to in subsection (1)(a) to the patient or relevant person (or both of them)—

(a) give the statements referred to in subsection (1)(a) to the patient or relevant person (or both of them)—

(i) at the meeting referred to in subsection (1)(a), or

(i) at the meeting referred to in subsection (1)(a), or

(ii) not later than 5 days from the date on which the meeting referred to in subsection (1)(a) was held, and

(ii) not later than 5 days from the date on which the meeting referred to in subsection (1)(a) was held, and

(b) give the statement referred to in subsection (1)(b), or (1)(c), to the patient or relevant person (or both of them)—

(b) give the statement referred to in subsection (1)(b), or (1)(c), to the patient or relevant person (or both of them)—

(i) at the meeting referred to in subsection (1)(b), or, as the case may be, at a clarification referred to in subsection (1)(c), or

(i) at the meeting referred to in subsection (1)(b), or, as the case may be, at a clarification referred to in subsection (1)(c), or

(ii) not later than 5 days from the date on which the meeting referred to in subsection (1)(b), or, as the case may be, the clarification referred to in subsection (1)(c), was held.

(ii) not later than 5 days from the date on which the meeting referred to in subsection (1)(b), or, as the case may be, the clarification referred to in subsection (1)(c), was held.

(3) Subsection (4) shall apply for the purposes of—

(3) Subsection (4) shall apply for the purposes of—

(a) an open disclosure meeting that is held other than in person and the provision of the statement referred to in section 16(5) to a patient or relevant person (or both of them) in accordance with section 16(2)(c) and the statement referred to in section 16(2)(d),

(a) an open disclosure meeting that is held other than in person and the provision of the statement referred to in section 16(5) to a patient or relevant person (or both of them) in accordance with section 16(2)(c) and the statement referred to in section 16(2)(d),

(b) an additional information meeting that is held other than in person and the provision of the statement referred to in section 18(6) to a patient or relevant person (or both of them) in accordance with section 18(4), and

(b) an additional information meeting that is held other than in person and the provision of the statement referred to in section 18(6) to a patient or relevant person (or both of them) in accordance with section 18(4), and

(c) a clarification provided under section 19 that is made other than in person and the provision of the statement referred to in section 19(3)(b) to a patient or relevant person (or both of them) in accordance with that section.

(c) a clarification provided under section 19 that is made other than in person and the provision of the statement referred to in section 19(3)(b) to a patient or relevant person (or both of them) in accordance with that section.

(4) A health services provider shall give—

(4) A health services provider shall give—

(a) the statements referred to in subsection (3)(a) to the patient or relevant person (or both of them) not later than 5 days from the day on which that meeting was held, and

(a) the statements referred to in subsection (3)(a) to the patient or relevant person (or both of them) not later than 5 days from the day on which that meeting was held, and

(b) the statement referred to in subsection (3)(b) or (3)(c) to the patient or relevant person (or both of them) not later than 5 days from the day on which the meeting referred to in subsection (3)(b), or, as the case may be, the clarification referred to in subsection (3)(c), was held.”.

(b) the statement referred to in subsection (3)(b) or (3)(c) to the patient or relevant person (or both of them) not later than 5 days from the day on which the meeting referred to in subsection (3)(b), or, as the case may be, the clarification referred to in subsection (3)(c), was held.”.

37.

37.

Section 21(1)(b)

Section 21(1)(b)

To delete “in writing”.

To delete “in writing”.

38.

38.

Section 21(1) new paragraph inserted

Section 21(1) new paragraph inserted

In section 21(1), to insert the following paragraph after paragraph (d)

In section 21(1), to insert the following paragraph after paragraph (d)

“(da) the request referred to in section 17(10),”.

“(da) the request referred to in section 17(10),”.

39.

39.

Section 21(1)(f)(ii)

Section 21(1)(f)(ii)

To delete “and”.

To delete “and”.

40.

40.

Section 21(1)(g)

Section 21(1)(g)

To delete “section 20(4)(c).” and substitute “section 20(4)(c), and”.

To delete “section 20(4)(c).” and substitute “section 20(4)(c), and”.

41.

41.

Section 21(1) new paragraph inserted

Section 21(1) new paragraph inserted

To insert the following new paragraph after paragraph (g)

To insert the following new paragraph after paragraph (g)

“(h) a record, or note, as the case may be, of a request (if any) referred to in section 15A(4) or 18(1D).”.

“(h) a record, or note, as the case may be, of a request (if any) referred to in section 15A(4) or 18(1D).”.