CIVIL LIABILITY (AMENDMENT) ACT 2017

was not available to the health services provider at the time of the making of the open disclosure of the patient safety incident and which, after that open disclosure of that incident was made, has become available and may, having regard to that additional information, make an apology, and such additional information and apology (if any) shall be provided, or made—

• (i) by the principal health practitioner who made the open disclosure of the patient safety incident in accordance with section 13,

• (ii) where, pursuant to section 13(1)(b), the open disclosure of the patient safety incident was made by a health practitioner referred to in section 13(2), by that health practitioner, or

• (iii) by a health practitioner referred to in subsection (2).

• (2) Where additional information referred to in subsection (1) is, in accordance with that subsection, to be provided (and an apology, if any, to be made) to a patient or relevant person (or both of them) and the person who, in accordance with section 13, made the open disclosure of the patient safety incident—

• (a) is not available to provide that additional information (or make an apology), or

• (b) is otherwise not in a position to provide that information (or make an apology),

that additional information (and apology, if any) shall be provided, or made, by a health practitioner whom the health services provider considers appropriate.

• (3) A health services provider shall make arrangements—

• (a) to meet with a patient or a relevant person (or both of them), or

• (b) where it is not practicable for a patient or a relevant person (or both of them) to attend at a meeting with the provider, for that patient or person (or both of them) to be contacted by telephone (or other similar method of communication),

for the purpose of providing that additional information (in this Part referred to as an “additional information meeting”).

• (4) When providing the additional information referred to in subsection (1) at an additional information meeting, a health services provider—

• (a) shall provide the additional information in accordance with subsection (5),

• (b) may provide the additional information—

• (i) orally, and

• (ii) in the order in which the health services provider considers appropriate, having regard to all the circumstances of the patient or the relevant person (or both of them) and the patient safety incident concerned,

and

• (c) shall give the patient or the relevant person (or both of them) a copy of the statement in writing referred to in subsection (6) or, in the case of an additional information meeting referred to in subsection (3)(b), shall deliver a copy of that statement to the patient or relevant person (or both of them) as soon as practicable after the meeting.

• (5) When providing the additional information referred to in subsection (1)—

• (a) the health services provider shall provide the names of the persons present at the additional information meeting,

• (b) the health services provider shall have regard to the provisions of section 16(3) and shall specify the provisions of that section to which the additional information, provided at the additional information meeting, refers,

• (c) without prejudice to paragraph (b), where having regard to the additional information provided, the health services provider has reasonable grounds for believing that further physical or psychological consequences referred to in section 16(3)(f), are likely to present or develop, the health services provider shall provide further information in respect of—

• (i) any physical or psychological consequences which, at the time the additional information meeting is held, have not presented, or developed, but which, notwithstanding such absence, the health services provider reasonably believes are likely to present or develop at any time after that meeting, and

• (ii) any physical or psychological consequences which, at the time of the additional information meeting, have not presented, or developed, and which the health services provider reasonably believes are less likely or unlikely to present or develop at any time after the holding of that meeting,

• (d) without prejudice to paragraph (b) and having regard to the additional information, where, at the time the additional information meeting is held—

• (i) any physical or psychological consequences arising from the patient safety incident have presented, or developed,

• (ii) the patient is under the clinical care of the health services provider concerned,

• (iii) having regard to the information referred to in section 16(3)(h) which was provided at the open disclosure meeting, and

• (iv) the health services provider proposes to make changes to the treatment, and relevant clinical care, the provider is providing to the patient to address those consequences,

the health services provider shall provide information relating to those changes to the treatment and clinical care.

• (6) The statement referred to in subsection (4)(c), that is to be given to the patient or the relevant person (or both of them) by the health services provider in accordance with that subsection, shall—

• (a) be in the prescribed form,

• (b) set out the additional information, specified in subsection (5), provided to the patient or the relevant person (or both of them) in accordance with that subsection,

• (c) contain an apology referred to in subsection (1) where such apology was made,

• (d) specify the day on which the additional information was provided to the patient or the relevant person (or both of them), and

• (e) be signed in accordance with subsection (7).

• (7) The statement in writing referred to in subsection (6) shall be signed by—

• (a) the principal health practitioner referred to in subsection (1)(i), or

• (b) the health practitioner referred to in subsection (1)(ii) or (1)(iii),

who provided the additional information to the patient or relevant person (or both of them) in accordance with this section.

• (8) The health services provider shall keep, in the records referred to in section 21, the statement referred to in subsection (6).

• (9) Nothing in this section shall operate to prevent the additional information being provided (and an apology, if any, being made), at the additional information meeting, to—

• (a) both the patient and the relevant person where the open disclosure of the patient safety incident (and an apology, if any) was made to either of them at the open disclosure meeting, and

• (b) a relevant person where—

• (i) the open disclosure of the patient safety incident (and an apology, if any) was made to the patient concerned at the open disclosure meeting, and

• (ii) the patient died subsequent to the time at which the open disclosure meeting was held.

(10)Section 10 shall apply to—

• (a) any information provided (or apology made) to the patient or the relevant person (or both of them) at the additional information meeting, in the same way as section 10 applies to information provided, and an apology where it is made, at an open disclosure meeting, and

• (b) the statement referred to in subsection (6) in the same way as it applies to the statement referred to in section 16(5).

19. Clarification of information provided at open disclosure meeting and additional information provided at additional information meeting

19. (1) A patient or relevant person (or both of them) to whom an open disclosure of a patient safety incident was made, may, at any time after the open disclosure meeting, or the additional information meeting as the case may be, make a request, to the designated person, for the clarification of—

• (a) any information provided to the patient or relevant person (or both of them) at the open disclosure meeting, or

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

• (2) Where a request is made under subsection (1)—

• (a) in the case of a request for clarification of the information provided at the open disclosure meeting, the designated person shall—

• (i) as soon as practicable, inform the person who, pursuant to section 13, made the open disclosure of the patient safety incident, or where the conditions in subsection (4) are satisfied, a health practitioner referred to in that subsection, of the request, and

• (ii) liaise with the person, or the health practitioner, referred to in subparagraph (i) in relation to the provision of a response to the request,

• (b) in the case of a request for clarification of the additional information provided at the additional information meeting, the designated person shall—

• (i) as soon as practicable, inform the person who, pursuant to section 18, provided the additional information at that meeting or, where the conditions in subsection (4) are satisfied, a health practitioner referred to in that subsection, of the request, and

• (ii) liaise with the person, or the health practitioner, referred to in subparagraph (i) in relation to the provision of a response to the request,

• (c) in the case of a request for clarification of the information provided at the open disclosure meeting, the person who, pursuant to section 13, made the open disclosure of the patient safety incident at the open disclosure meeting, or where the conditions referred to in subsection (4) are satisfied, a health practitioner referred to in that subsection, shall—

• (i) provide the clarification to the patient or relevant person (or both of them), in so far as it is reasonably open to him or her to do so having regard to the information available to him or her at the time he or she provides the clarification, and

• (ii) liaise with the designated person in relation to the provision of the clarification referred to in subparagraph (i),

• (d) in the case of a request for clarification of additional information provided at an additional information meeting, the person who, pursuant to section 18, provided the additional information at the additional information meeting, or where the conditions in subsection (4) are satisfied, a health practitioner referred to in that subsection, shall—

• (i) provide the clarification to the patient or relevant person (or both of them) in so far as it is reasonably open to him or her to do so having regard to the information available to him or her at the time he or she provides the clarification, and

• (ii) liaise with the designated person in relation to the provision of the clarification referred to in subparagraph (i),

and

• (e) the designated person shall—

• (i) set out, in a statement in writing, in the prescribed form—

• (I) the request for clarification made under subsection (1), and

• (II) the date on which the clarification requested under subsection (1) was provided,

and

• (ii) keep, in the records referred to in section 21, the statement in writing referred to in subparagraph (i).

• (3) For the purposes of providing the clarification requested under subsection (1), the person who, pursuant to section 13, made the open disclosure of the patient safety incident at the open disclosure meeting, the person who, pursuant to section 18, provided the additional information at the additional information meeting, or, where the conditions referred to in subsection (4) are satisfied, a health practitioner referred to in that subsection, as the case may be—

• (a) may provide that clarification orally, and

• (b) shall give a copy of the statement in writing referred to in subsection (5) to—

• (i) the designated person, and

• (ii) the patient or relevant person (or both of them) who made the request under subsection (1).

• (4) Where a request is made under subsection (1) and the person who—

• (a) pursuant to section 13, made the open disclosure of the patient safety incident at the open disclosure meeting, or

• (b) pursuant to section 18, provided the additional information at the additional information meeting,

is not available to provide the clarification requested under subsection (1)—

• (i) the designated person shall notify the health services provider, and

• (ii) the clarification shall be provided by a health practitioner whom the health services provider, having considered the patient safety incident concerned, considers appropriate.

• (5) The statement in writing referred to in subsection (3)(b) that is to be given, in accordance with that subsection, to the persons specified in that subsection, shall—

• (a) be in the prescribed form,

• (b) set out the information provided in the clarification,

• (c) specify the date on which the clarification was provided to the persons referred to in subsection (3), and

• (d) be signed in accordance with subsection (6).

• (6) The statement in writing referred to in subsection (5) shall be signed by the person who provided the clarification.

• (7) The health services provider shall keep, in the records referred to in section 21, the statement in writing referred to in subsection (5).

(8)Section 10 shall apply to—

• (a) information provided in a clarification made to a patient or relevant person (or both of them) pursuant to a request made under subsection (1) in the same way as that section applies to information provided to a patient or relevant person (or both of them) at an open disclosure meeting or an additional information meeting as the case may be, and

• (b) the statement in writing referred to in—

(i)subsection (2)(e), and

(ii)subsection (5),

in the same way as that section applies to the statement referred to in section 16(5).

20. Failure to contact patient for purpose of open disclosure of patient safety incident

20. (1) Where—

• (a) pursuant to section 16(1), a health services provider is unable to contact a patient for the purpose of arranging an open disclosure meeting on the basis of the contact information provided to it by the patient, and

• (b) the open disclosure of the patient safety incident is to be made to the patient in accordance with section 12(a),

the health services provider concerned shall take all steps reasonably open to the provider to establish contact with the patient for the purpose of arranging the open disclosure meeting.

• (2) Where—

• (a) pursuant to section 16(1), a health services provider is unable to contact a relevant person for the purpose of arranging an open disclosure meeting on the basis of the contact information provided to it by the patient or relevant person, and

• (b) the open disclosure of the patient safety incident is to be made to the relevant person in accordance with subparagraph (i), (ii) or (iii) of paragraph (b) of section 12,

the health services provider concerned shall take all steps reasonably open to the provider to establish contact with the relevant person for the purpose of arranging the open disclosure meeting.

• (3) Where—

• (a) pursuant to section 16 (1), a health services provider is unable to contact a patient and relevant person for the purpose of arranging an open disclosure meeting on the basis of the contact information provided to it by the patient or relevant person, and

• (b) the open disclosure of the patient safety incident is to be made to both the patient and the relevant person in accordance with subparagraph (i) or (ii) of paragraph (c) of section 12,

the health services provider concerned shall take all steps reasonably open to the provider to establish contact with the patient and relevant person for the purpose of arranging the open disclosure meeting.

• (4) A health services provider shall—

• (a) set out, in a statement in writing, in the prescribed form, the steps taken by it to establish contact with a patient, relevant person or, as the case may be both of them,

• (b) sign the statement referred to in paragraph (a) and shall specify the date of signing, and

• (c) keep, in records referred to in section 21, the statement referred to in paragraph (a), which has been signed in accordance with paragraph (b).

• (5) In this section “contact information” means information provided to a health services provider by the patient or a relevant person (or both of them) for the purpose of permitting the provider to contact the patient or relevant person (or both of them) as it may require having regard to the health service being provided to the patient when the patient is no longer in the care of the provider or has left the premises on which the health service concerned is provided to that patient.

21. Records relating to open disclosure of patient safety incident

21. (1) A health services provider shall keep and maintain records in relation to—

• (a) a copy of the designation referred to in section 15(3),

• (b) the statement in writing referred to in section 16(7),

• (c) the statement referred to in section 17(3)(d) or section 17(5)(d), as the case may be,

• (d) the note referred to in section 17(6)(iii),

• (e) the statement in writing referred to in section 18(8),

• (f) the statement in writing—

• (i) of a request referred to in section 19(2)(e), and

• (ii) referred to in section 19(7),

and

• (g) the statement referred to in section 20(4)(c).

• (2) The Minister may prescribe the form of the records to be kept and maintained by a health services provider under this section and any matter relating to the keeping and maintenance of such records.

22. Regulations

22. (1) The Minister may by regulations provide for any matter referred to in this Part as prescribed or to be prescribed.

• (2) Without prejudice to any provision of this Part, regulations under this section may contain such incidental, supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purposes of the regulations.

• (3) Every regulation made by the Minister under this Part shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the regulation is passed by either such House within the next 21 days on which that House sits after the regulation is laid before it, the regulation shall be annulled accordingly, but without prejudice to the validity of anything previously done thereunder.

23. Savings and transitional provisions for this Part

23. (1) This Part shall apply to the making of an open disclosure of a patient safety incident by a health services provider on or after the coming into operation of this Part.

• (2) Where a patient safety incident occurred, or came to the notice of a health services provider, before the day on which this Part comes into operation, a health services provider may, on or after the coming into operation of this Part, make an open disclosure of that incident in accordance with this Part.

• (3) For the purposes of making an open disclosure of a patient safety incident pursuant to subsection (2), the reference in section 14(1)(a) to “as soon as practicable” shall be construed as being as soon as practicable after the coming into operation of this Part.