Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

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Review of specified incident by chief inspector

68. The Act of 2007 is amended by the insertion of the following section after section 41:

“41A. (1) This section applies where it appears to the chief inspector that a specified incident has occurred, following—

(a) the receipt by the chief inspector of a complaint in relation to the specified incident concerned,

(b) the notification of the specified incident concerned to the chief inspector by a relevant entity, or

(c) the chief inspector otherwise becoming aware of the specified incident concerned.

(2) Subject to subsection (4), the chief inspector may undertake a review of the specified incident where he or she considers it appropriate to do so, having regard to all of the circumstances, in order to—

(a) identify, in so far as possible, how the specified incident concerned occurred, and

(b) make any recommendations of a general character arising out of any findings under paragraph (a) that can be implemented to reduce risk and to improve the safety, quality and standards of services provided by the relevant entity or relevant entities, as the case may be, where the specified incident occurred.

(3) The chief inspector may decide not to undertake a review under this section, or decide to discontinue such a review, if—

(a) subsection (1)(a) applies and the chief inspector believes on reasonable grounds that the complaint is frivolous or vexatious,

(b) the specified incident, the subject of the review concerned, has already been subject to a review under this section,

(c) the chief inspector believes on reasonable grounds that the incident the subject of the review concerned is not a specified incident,

(d) the chief inspector believes on reasonable grounds that, the subject matter of the review concerned has already been resolved or substantially resolved,

(e) the subject matter of the review concerned is the subject of criminal proceedings, or

(f) the review concerned is the subject of an investigation by An Garda Síochána.

(4) The chief inspector shall not undertake a review of a specified incident under subsection (2)—

(a) where subsection (1)(a) applies, after the expiration of one year from the later of the following dates:

(i) the date on which the specified incident occurred;

(ii) the date on which the complainant knew or could reasonably be expected to know that the specified incident occurred,

or

(b) where subsection (1)(b) or (c) applies, after the expiration of one year from the date on which the specified incident occurred.

(5) Without prejudice to Part 9 of the Health Act 2004 , each of the following persons may make a complaint to the chief inspector in relation to a specified incident, and where he or she does so each such person shall, in this section, be referred to as a ‘complainant’:

(a) the patient;

(b) a parent, guardian, son, daughter, spouse or civil partner (within the meaning of the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 ) of the patient;

(c) a person who is cohabiting with the patient (including a cohabitant within the meaning of section 172 of the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 );

(d) any person who, by law or by appointment of a court, has the care of the affairs of the patient;

(e) any legal representative of the patient;

(f) any other person, with the written consent of the patient.

(6) Where a review under this section is being undertaken in respect of a specified incident, the chief inspector shall—

(a) give notice in writing to the relevant entity concerned of the matters to which the review relates, and

(b) give the relevant entity concerned a copy of any document which in the reasonable opinion of the chief inspector is relevant to the review.

(7) A review of a specified incident undertaken under subsection (2) shall not—

(a) consider or determine fault, or assign civil or criminal liability,

(b) consider or determine whether any action should be taken in respect of an individual by any panel, committee, tribunal or professional regulatory body, or

(c) be admissible as evidence of fault or liability in a court in relation to the specified incident, or a clinical negligence action which arises (whether in whole or in part) from the consequences of that specified incident.

(8) Nothing in this section shall be construed as preventing a relevant entity from undertaking a review of a specified incident that may have occurred.

(9) The chief inspector shall ensure that a review under this section does not interfere, or conflict, with the functions of any statutory bodies.

(10) In this section—

‘complaint’ means a complaint, in any form, made by a complainant in relation to a specified incident that may have occurred during the provision of a health service by a relevant entity to a patient;

‘patient’ means a person to whom a health service is, or has been, provided by a relevant entity;

‘relevant designated centre’ means a designated centre to which paragraph (c) of the definition of designated centre in section 2 applies, that is registered in accordance with section 49 and includes—

(a) a designated centre whose registration has been cancelled under section 51 where an appeal against the cancellation has been made and has not been determined or withdrawn or in respect of which an appeal has been made under section 62 and that appeal has not been determined or withdrawn, and

(b) a designated centre in respect of which an application was made to the District Court under section 59 and the application has not been determined or withdrawn or in respect of which an appeal has been made under section 62 and that appeal has not been determined or withdrawn;

‘relevant entity’ means—

(a) a service provider to which paragraph (a), (b) or (d) of the definition of ‘service provider’ in section 2 applies,

(b) a relevant designated centre that is not a service provider referred to in paragraph (a),

(c) a person carrying on the business of providing a prescribed private health service, or

(d) the Executive;

‘specified incident’ means an incident that occurs on or after the coming into operation of this section—

(a) that may have resulted in the unintended or unanticipated death or serious injury of a patient, and

(b) that has occurred in the course of the provision of a health service to that patient by a relevant entity, where some or all of that health service was provided in a relevant designated centre.”.