Open Disclosure

Table of Contents

Key Definitions

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

A qualifying recipient”, in relation to a patient, means a person

who is a parent, guardian, son or daughter, ) a spouse, or ) a civil partner of the patient,
who is cohabiting with the patient
whom the patient has nominated in writing to the health services provider as a person to whom clinical information in relation to the patient may be disclosed.

Meaning of “patient safety incident”

A patient safety incident”, means—

an incident which has caused an unintended or unanticipated injury, or harm, to the patient and which occurred in the course of the provision of a health service to that patient,
an incident— which has occurred in the course of the provision of a health service to the patient and did not result in actual injury or harm, and) in respect of which the health services provider has reasonable grounds to believe placed the patient at risk of unintended or unanticipated injury or harm, or
the prevention, whether by timely intervention or by chance, of an unintended or unanticipated injury, or harm, to the patient in the course of the provision, to him or her, of a health service, and in respect of which the health services provider has reasonable grounds for believing that, in the absence of such prevention, could have resulted in such injury, or harm, to the patient.

Open disclosure of patient safety incident

Where a health services provider discloses, at an open disclosure meeting, to—

a patient that a patient safety incident has occurred in the course of the provision of a health service to him or her,
a qualifying recepient that a patient safety incident has occurred in the course of the provision of a health service to the patient concerned, or
a patient and a qualifying recepient that a patient safety incident has occurred in the course of the provision of a health service to the patient,

that disclosure must be treated as an open disclosure by the health services provider of that patient safety incident.

The following protections must apply to—

the information, in respect of the patient safety incident, provided to the patient or qualifying recepient (or both of them) at the open disclosure meeting, additional information provided at the additional information meeting and information provided in a clarification
an apology, in respect of the patient safety incident, where an apology is made at that meeting, or the additional information meeting.

Open disclosure: information and apology not to invalidate insurance; constitute admission of liability or fault; or not to be admissible in proceedings

Information provided, and an apology where it is made, to a patient or a qualifying recepient (or both of them) by a health services provider at an open disclosure meeting in respect of a patient safety incident, and certain statements mentioned below must not constitute an express or implied admission of fault or liability by—

that health services provider,
an employee of that provider (whether the employee is a health practitioner or otherwise),
a health practitioner who provides, or provided, a health service for, or on behalf of, that provider pu
an agency health practitioner who provides, or provided, a health service for, or on behalf of, that provider,
a health practitioner including, in the case of a health services provider which is a partnership, a partner of a health practitioner, providing a health service for that provider,
an agency worker assigned to that provider pursuant to an agency contract,

Such information is not, n admissible as evidence of fault or liability in a court in relation to that patient safety incident or a clinical negligence action which arises (whether in whole or in part) from the consequences of that patient safety incident.

It must not, invalidate or otherwise affect the cover provided by such policy or contract of insurance that is, or but for such information and such apology would be, available in respect of the patient safety incident concerned or any matter alleged which arises (whether in whole or in part) from that patient safety incident.

Information provided, and an apology where it is made, to a patient or a qualifying recepient (or both of them) by a health services provider at an open disclosure meeting must not constitute an express or implied admission, by a health practitioner, of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in the context of any disciplinary proceedings and complaints that is made in respect of the health practitioner and which arises (whether in whole or in part) from the consequences of that patient safety incident, and

They must not be , admissible as evidence of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission, in proceedings to determine a complaint, application or allegation referred to in paragraph (a).

Statement re disclosure procedure

A health services provider must prepare a statement in writing of—

the procedure for making an open disclosure of a patient safety incident
the manner in which the above limitations on the use of the information applies to the information provided, and any apology made, at the open disclosure meeting, the additional information meeting, or the information provided in a clarification and any statements in writing provided in respect of those meetings or that clarification.

The Minister may make guidelines in respect of the form of the statement.

Voluntary open disclosure of patient safety incident

Where a patient safety incident occurs in the course of the provision by a health services provider of a health service to a patient, the health services provider may make, , an open disclosure of the patient safety incident to to the the patient concerned, or a qualifying recepient where—

in the opinion of the health services provider, having had regard to the age, capacity or health of the patient who is the subject of the patient safety incident, it is appropriate that the open disclosure of that incident is made to a qualifying recepient
the patient has died, or
the patient has requested the health services provider to make the open disclosure of the patient safety incident to the qualifying recepient and not to the patient,

The statement may be made both the patient and a qualifying recepient where—

in the opinion of the health services provider, having had regard to the age or capacity of the patient who is the subject of the patient safety incident, it is appropriate that the open disclosure of that incident is made to both the patient and a qualifying recepient, or
before the open disclosure meeting is held, the patient has requested that the health services provider makes the open disclosure of the patient safety incident to a qualifying recepient as well as that patient.

Making of open disclosure

The open disclosure of a patient safety incident must be made on behalf of a health services provider by the principal health practitioner, in relation to the patient to whom, or in respect of whom, the open disclosure of the patient safety incident is to be made.

Where, the principal health practitioner is not available or otherwise not in a position to make the open disclosure of the patient safety incident, or having had regard to the circumstances of the patient safety incident, the health services provider, or the principal health practitioner , is satisfied that the open disclosure of that incident should be made by another health practitioner, the open disclosure of that patient safety incident must be made by a health practitioner whom the health services provider, having considered the patient safety incident concerned, considers appropriate.

Time of making of open disclosure

Where a health services provider has reasonable grounds for believing that a patient safety incident has occurred, the health services provider concerned must make the open disclosure of that patient safety incident at a time it considers to be appropriate having regard to—

the desirability, suof making the open disclosure as soon as practicable notwithstanding that— some, or all, of the likely consequences of the patient safety incident are not present or have not developed, and the health services provider does not have all of the information relating to the patient safety incident available to it when the open disclosure of the incident is made,
all the circumstances of the patient and the nature, and consequences, of the patient safety incident concerned, and
the below requirements .

Having considered the appropriate time for making the open disclosure of the patient safety incident, the health services provider must take all steps reasonably open to it to make the open disclosure as soon as practicable following that consideration.

Matters to be addressed by health services provider before making open disclosure of patient safety incident

Before making an open disclosure of a patient safety incident, a health services provider must in order to determine the appropriate time at which to make the open disclosure to the patient or qualifying recepient (or both of them)

make an assessment of all the circumstances of the patient and the nature of the patient safety incident concerned, and
consult, having had regard to the circumstances referred to in subparagraph (i), with such other person (if any) as the health services provider considers appropriate,

They must

determine, whether the open disclosure of the patient safety incident concerned is to be made to the patient or the qualifying recepient (or both of them), h
determine whether, having regard to the nature and circumstances of the patient safety incident concerned, it is appropriate for an apology to be made to the patient or the qualifying recepient (or both of them) at the open disclosure meeting,
consider the information relating to the patient safety incident and, having regard to the complexity of that information, take all steps as are reasonably open to the health services provider to present that information in as clear a manner as is possible having regard to that complexity,
designate, a person to liaise with the health services provider and the patient or qualifying recepient (or both of them) in relation to the open disclosure of the patient safety incident (in this Part referred to as “designated person”) and in respect of a request for clarification u , and
make arrangements for the preparation of the statement in writing, r, that is to be provided to the patient or qualifying recepient (or both of them) at the open disclosure meeting.

Open disclosure meeting

A health services provider must, make arrangements—to meet with a patient or a qualifying recepient (or both of them), or where it is not practicable for a patient or a qualifying recepient (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 making an open disclosure of a patient safety incident in respect of which the patient, or patient to whom the qualifying recepient is connected, is the subject (in this Part referred to as an “open disclosure meeting”).

When making an open disclosure of a patient safety incident at an open disclosure meeting, a health services provider—

must provide the patient, or the qualifying recepient (or both of them), with the information specified below, which, the health services provider has in its possession at the time the open disclosure meeting is held,
may provide the information specified orally, and in the order in which the health services provider considers appropriate, having regard to all the circumstances of the patient or the qualifying recepient (or both of them) and the patient safety incident concerned,
must give the patient or the qualifying recepient (or both of them) a copy of the statement in writing or, in the case of an open disclosure meeting re must deliver a copy of that statement to the patient or qualifying recepient (or both of them) as soon as practicable after the meeting, and
must provide the statement to the patient or qualifying recepient (or both of them) or, in the case of an open disclosure meeting ), must deliver that statement to the patient or qualifying recepient (or both of them) as soon as practicable after the meeting.

The information to be provided above must be as follows:

the names of the persons present at the open disclosure meeting;
a description of the patient safety incident concerned;
the date on which the patient safety incident occurred, and the patient safety incident came to the notice of the health services provider;
the manner in which the patient safety incident came to the notice of the health services provider;
where, in the opinion of the health services provider, physical or psychological consequences of the patient safety incident which, at the time the open disclosure meeting is held, are present or have developed, information in respect of those consequences;

Consequences of Incident

Where the health services provider has reasonable grounds for believing that, in addition to the consequences referred to , further physical or psychological consequences of the patient safety incident are likely to present or develop, information in respect of— the physical or psychological consequences which, at the time the open disclosure 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 the open disclosure meeting, and the physical or psychological consequences which, at the time of the open disclosure 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 the open disclosure meeting;

Where the health services provider has reasonable grounds for believing that no physical or psychological consequences are likely to present or develop from the patient safety incident, a statement to that effect;

Where, at the time of the open disclosure meeting—any physical or psychological consequences arising from the patient safety incident have presented, or developed, and the patient is under the clinical care of the health services provider concerned, the health services provider must provide the patient with information in respect of the treatment, and relevant clinical care, the provider is providing to the patient to address those consequences;) having regard to the consideration, by the health services provider, of the patient safety incident—the actions the health services provider has taken, or proposes to take, and procedures or processes to be implemented, in order to, in so far as it is reasonably open to it to do so, address the knowledge the provider has obtained from its consideration of the patient safety incident and the circumstances giving rise to that incident.

Apology

Where, the health services provider has determined that an apology is to be made to the patient or the qualifying recepient (or both of them), the health services provider concerned may, at the open disclosure meeting, make the apology to the patient or the qualifying recepient (or both of them) in respect of that patient safety incident.

The statement in writing referred to iabove ,that is to be given to the patient or the qualifying recepient (or both of them) in accordance with that subsection, must

be in the prescribed form,
set out the above information, s, provided to the patient or the qualifying recepient (or both of them) in
contain an apology where such apology was made,
specify the day on which the open disclosure of the patient safety incident was made, and
be signed

The health services provider must keep statement in its records.

Non-Participation

The patient or a qualifying recepient are not obliged to engage with the health services provider in the open disclosure of a patient safety incident. Where a health services provider informs a patient or a qualifying recepient that the provider proposes to hold an open disclosure meeting and the patient or qualifying recepient does not want to attend that open disclosure meeting, the patient or qualifying recepient must inform that provider that he or she—

will not attend the open disclosure meeting,
does not wish to receive the information which is to be provided at that meeting, and
does not wish to receive, ny additional information that may be provided (or apology that may be made)

In this event the provider must—

set out a statement in writing, in the prescribed form, of those matters,
sign that statement and specify the date on which it was signed,
provide the patient, qualifying recepient or, as the case may be, both of them with a copy of that statement which has, in accordance with paragraph (b), been signed by the provider, as soon as practicable,
maintain the statement which has, in accordance with paragraph (b), been signed by the provider, in the records r
pursuant to that statement, not proceed to hold the open disclosure meeting.

Provision of additional information and clarification

A health services provider may, at any time after the holding of the open disclosure meeting, provide information that is additional to the information, to the patient or qualifying recepient (or both of them) at the open disclosure meeting (“additional information”) that,
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 reard to that additional information, make an apology, and such additional information and apology (if any) must be provided. Similar criteria and procedures apply to those above in relation to the provision of additional information.

A patient or qualifying recepient (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—

any information provided to the patient or qualifying recepient (or both of them) at the open disclosure meeting, or
any additional information provided to the patient or qualifying recepient (or both of them) at the additional information meeting. Procedures apply in relation to furnishing clarification

Failure to contact

Where, 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 the open disclosure of the patient safety incident is to be made to the patient in accordance the health services provider concerned must take all steps reasonably open to the provider to establish contact with the patient for the purpose of arranging the open disclosure meeting.

Where the health services provider is unable to contact a qualifying recepient for the purpose of arranging an open disclosure meeting on the basis of the contact information provided to it by the patient or qualifying recepient, and the open disclosure of the patient safety incident is to be made to the qualifying recepient the health services provider concerned must take all steps reasonably open to the provider to establish contact with the qualifying recepient for the purpose of arranging the open disclosure meeting.

Where the health services provider is unable to contact a patient and qualifying recepient for the purpose of arranging an open disclosure meeting on the basis of the contact information provided to it by the patient or qualifying recepient, procedures and required steps apply

Records relating to open disclosure of patient safety incident

A health services provider must keep and maintain records in relation to the above procedures. 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.

2023 Act – Complainants

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’:

the patient;
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;
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);
any person who, by law or by appointment of a court, has the care of the affairs of the patient;
any legal representative of the patient;
any other person, with the written consent of the patient.

Review

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

give notice in writing to the relevant entity concerned of the matters to which the review relates, and
give the relevant entity concerned a copy of any document which in the reasonable opinion of the chief inspector is relevant to the review.

A review of a specified incident shall not—

consider or determine fault, or assign civil or criminal liability,
consider or determine whether any action should be taken in respect of an individual by any panel, committee, tribunal or professional regulatory body, or
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.

This does not prevent relevant entity from undertaking a review of a specified incident that may.

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

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

Investigation Powers

If the chief inspector considers it necessary or expedient for the purposes of a review the chief inspector may enter and inspect at any time any premises—

owned or controlled by a relevant entity, or
used or proposed to be used for any purpose connected with the provision of a health service by a relevant entity.

A chief inspector, in respect of premises referred to, may—

inspect, take copies of or extracts from and remove from the premises any documents or records (including personal records) relating to the services provided by a relevant entity.
inspect the operation of any computer and any associated apparatus or material which is or has been in use in connection with the records in question,
inspect any other item and remove it from the premises if the chief inspector considers it necessary or expedient for the purposes of a review
interview in private any person— working at the premises concerned, or who at any time was or is in receipt of a service at the premises and who consents to be interviewed, and
make any other examination into the state and management of the premises or the standard of any services provided at the premises.”,

Reports of Authority or chief inspector

The Authority or the chief inspector may prepare and publish a report relating to the functions and activities of the Authority, or the chief inspector, as the case may be. A report prepared may include information on—

the monitoring of compliance with standards
any investigation carried out, and
any review carried out.

Where preparing a report providing information the Authority or the chief inspector as the case may be, shall give to the Executive, the Agency, a service provider, a person carrying on the business of providing a prescribed private health service, or the registered provider of a designated centre or the person in charge of that designated centre if other than its registered provider a draft of the report (in this section referred to as a ‘draft report’) along with a written notice stating that the person may, not later than 21 days from the date on which the notice was received by him or her, or such further period as the Authority allows, make written submissions to the Authority or the chief inspector on the draft report.

In the case of a report which includes information on a review referred to in subsection (2)(c), the chief inspector shall also give to the patient and, as the case may be, the complainant to whom the review relates an extract from the draft report which relates to the review concerned along with a written notice stating that the person may, not later than 21 days from the date on which the notice was received by him or her, or such further period as the chief inspector allows, make written submissions to the chief inspector on the extract from the draft report.

As soon as practicable after the expiration of the period referred to and, having considered any submissions made pursuant to those subsections, the Authority or the chief inspector as the case may be, may amend the draft report and, prior to publication, shall furnish the final report to—

the Executive,
the Agency,
a service provider,
a person carrying on the business of providing a prescribed private health service,
the registered provider of a designated centre or the person in charge of that designated centre if other than its registered provider, or
in the case of a report which includes information on a review referred to, the patient and, as the case may be, the complainant.

The Authority or the chief inspector is not liable in damages arising from any report or communication made in good faith for the purposes of, or in the performance of, the functions under this section.”.