Civil Liability (Amendment) Bill 2017: Committee Stage

SECTION 1

Amendments Nos. 1 and 2 are related and may be discussed together, by agreement. Is that agreed? Agreed.

Government amendment No. 1:
In page 3, line 18, after "Act" to insert ", other than Part 4,".

Amendments Nos. 1 to 20, inclusive, seek to insert a new Part 4 into the Civil Liability (Amendment) Bill 2017 to support the open disclosure of patient safety incidents. Senators will recall that in the course of her Second Stage speech the Tánaiste indicated that such amendments would be brought forward. Accordingly, I am very pleased to propose the amendments for consideration by the House. On behalf of the Minister for Health, I thank the Oireachtas Joint Committee on Health for undertaking pre-legislative scrutiny of the provisions which was very helpful in ensuring the legislation would be brought forward today as a positive measure that represents an important part of ongoing patient safety initiatives in the health service. There are 20 amendments in total, including a consequential amendment to the Long Title of the Bill. With the agreement of the House, it is my intention to take the amendments in thematic groups which will follow the narrative of Part 4.

The first group includes amendments Nos. 1 and 2.

These introductory amendments seek to amend section 1 to include reference to Part 4 - the new provisions on open disclosure.

The second grouping is amendments Nos. 3 and 4, which address definitional matters relevant to the new Part 4. The third grouping consists of amendments Nos. 5 and 6. Those amendments detail what an open disclosure is, what its legal effect is and the statement to be prepared by the health service provider in regard to open disclosure. The fourth grouping is amendments Nos. 8 to 11, inclusive, 13 and 16, which provide for the steps involved in the open disclosure process, including what happens when a person does not wish to participate in the process or the health service provider cannot get in touch with the patient for the purposes of arranging an open disclosure meeting. The next grouping is amendments Nos. 12, 14 and 15. These amendments cover the requirements for the conduct of the open disclosure meeting and for the provision of further information and clarification of information provided. Amendments Nos. 17 to 19, inclusive, will be taken separately. They deal, respectively, with the records to be kept, the making of ministerial regulations, and saving and transitional arrangements when Part 4 is commenced. Amendment No. 20 involves a change to the Long Title of the Bill and is consequential to the other amendments being carried.

Before I deal with the amendments, I would like to take this opportunity to speak about the purpose of Part 4. The provisions to support open disclosure are part of a broader package of reforms aimed at improving the experience of those who are affected by adverse events within the health service. Last December, the Minister for Health launched a new national patient safety office, located in the Department of Health, to prioritise work in this area. He has directed this office to work on a range of initiatives, including new legislation, the establishment of a national patient advocacy service, the measurement of patient experience, the introduction of a patient safety surveillance system and extending the clinical effectiveness agenda. Within the programme of legislation, it is intended to progress the licensing of our public and private hospitals.

These reforms also include the provisions on periodic payment orders in the Civil Liability (Amendment) Bill. While the open disclosure provisions were originally to be included in the Health Information and Patient Safety Bill, it was thought that they would be a good fit with the Civil Liability (Amendment) Bill, which was more advanced than the Health Information and Patient Safety Bill. Patient safety is fundamental to the delivery of quality health care and to public confidence in the health system, and open disclosure is an integral element of patient safety incident management and learning. Open disclosure is about an open, honest and consistent approach to communicating with patients and families when things go wrong in health care. It includes keeping the patient informed, providing feedback on investigations and the steps taken to prevent a recurrence of the incident, and it may include, depending on the particular circumstances involved, an apology for what happened. For those reasons, open disclosure is important for building patient and public trust in the health system and it is therefore vital that it should be supported.

The report of the Commission on Patient Safety and Quality Assurance, chaired by Professor Deirdre Madden, recommended that legislation be enacted to provide legal protection for open disclosure of patient safety incidents to patients. It is envisaged that such legislation should ensure that open disclosure, which is undertaken in compliance with national standards, cannot be used in litigation against the person making the disclosure.

International experts' experience indicates that open disclosure will happen best by fostering the development of an honest and honest culture. In its consideration of these provisions the Oireachtas Joint Committee on Health recognised that the best chance of creating the conditions necessary for the success of open disclosure lies in taking a voluntary approach backed up by apology laws. In responding to the committee's observations and in order to properly take account of experience into the future, the Minister for Health has indicated that the structured evaluation of the success of voluntary open disclosure will be undertaken in the future once a suitable period of time has elapsed.

The open disclosure legislative provisions in Part 4 are therefore designed to give legal protections for the information disclosed and any apology made during the open disclosure process but only when the information provided and the apology made is in keeping with the requirements set out in the legislation. The section setting out protections is section 10, while the other sections of Part 4 stipulate requirements on the open disclosure process to ensure that it is an open and patient-centred process.

These protections address a situation in the health service at the moment where health practitioners could be reluctant to make a disclosure to a patient regarding a patient safety incident because of concerns they may have in regard to the potential consequences it could have for their career as well as the financial implications that may arise with regard to insurance. I wish to be clear, however, that there is no question that the protections being proposed will provide for protections for incompetent, negligent or other unprofessional patient care. Clinicians will still operate within the existing accountability framework, including through the bodies regulating their particular professions. The objective of the legislation is to create a safe place for open disclosure and to encourage the growth of a culture of openness and transparency within our health service, ensuring that patients are getting relevant information when an open disclosure is made. The protections provided will apply in both the public and private sides of the health service so as to support a uniformed system of open disclosure across the health system.

I will now deal with the specific amendments. Amendments Nos. 1 and 2, which are being taken together, amend section 1 of the Civil Liability (Amendment) Bill to insert references to the new Part 4 concerning open disclosure as that part of the Bill will be the responsibility of the Minister for Health rather than the Minister for Justice and Equality. The intention is that the commencement of Part 4 would be a matter for the Minister for Health. The Tánaiste has also asked me inform the House that she is considering tabling further amendments on Report Stage in regard to a number of issues related to the periodic payments part of the Bill.

Section 51O provides that the Part dealing with periodic payment orders will apply to proceedings which are brought on or after the commencement of the Part or in respect of which no final decision has been made on the date of such commencement. The Tánaiste is examining the issue with the Office of the Attorney General to ensure that the provisions on periodic payment orders can only apply to cases where a court has already made an internal award and, if necessary, the Tánaiste will bring forward an amendment on Report Stage to clarify this matter for Senators.

The Tánaiste also notes that discussions are under way between her Department, the Department Jobs, Enterprise and Innovation and the Office of the Attorney General on the possibility of giving the Personal Injuries Assessment Board the power to make periodic payment orders in catastrophic injury cases. Again, if required, the Tánaiste will bring forward any appropriate amendments and information on Report Stage.

My Department and the State Claims Agency are preparing comprehensive provisions dealing with recovery of costs, specified health and personal social care services in the cases of persons who are in receipt of periodic payment orders. This is to avoid a situation referred to as double recovery where a person in receipt of the periodic payment order for the purpose of his or her long-term health care need also receives health benefits under, for example, a medical card. It would also be necessary to avoid the situation where, for example, a defendant could seek to reduce the amount of damages payable because of a plaintiff's entitlement to a medical card. The intention is to table the required amendments on Report Stage.

Amendment agreed to.
Government amendment No. 2:
In page 3, between lines 21 and 22, to insert the following:
“(4) Part 4 shall come into operation on such day or days as the Minister for Health may by order or orders appoint either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or different provisions.”.
Amendment agreed to.
Section 1, as amended, agreed to.
Sections 2 to 6, inclusive, agreed to.
NEW SECTIONS

Amendments Nos. 3 and 4 are related and they may be discussed together by agreement. Is that agreed? Agreed.

Government amendment No. 3:
In page 14, after line 15, to insert the following:
“PART 4
OPEN DISCLOSURE OF PATIENT SAFETY INCIDENTS
CHAPTER 1
General
Interpretation
7. (1) In this Part—
“Act of 1985” means the Dentists Act 1985;
“Act of 2005” means the Health and Social Care Professionals Act 2005;
“Act of 2007” means the Medical Practitioners Act 2007;
“Act of 2010” means the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010;
“Act of 2011” means the Nurses and Midwives Act 2011;
“additional information” shall be construed in accordance with section 18(1);
“additional information meeting” has the meaning assigned to it by section 18;
“agency contract”, in relation to a health services provider, means a contract between an employment agency and a health services provider by virtue of which an agency worker or an agency health practitioner—
(a) is assigned to work for the health services provider, and in the case of an agency health practitioner, to provide a health service, for (or on behalf of) the health services provider, and
(b) remains under the direction and supervision of the health services provider;
“agency health practitioner”, in relation to a health services provider, means an agency worker who—
(a) is a health practitioner, and
(b) under an agency contract, is assigned to work for the health services provider, and the work to be carried out is to provide a health service for (or on behalf of) the health services provider,
and a reference to an agency health practitioner, in relation to a health services provider, shall be construed as a reference to an agency health practitioner who provides a health service for the health services provider and is under the direction and supervision of that health services provider;
“agency worker”, in relation to a health services provider, means a person who is employed by an employment agency under a contract of employment by virtue of which that person may be assigned to work for the health services provider, and a reference to an agency worker, in relation to a health services provider, shall be construed as a reference to an agency worker who works for a health services provider and is under the direction and supervision of that provider;
“apology”, in relation to an open disclosure of a patient safety incident, means an expression of sympathy or regret;
“designated person” means a person designated under section 15(1)(e);
“employee”, in relation to a health services provider, means—
(a) a person who—
(i) has entered into, or works under (or where the employment has ceased, had entered into or worked under), a contract of employment, with the health services provider, or
(ii) is (or was) placed for the purpose of vocational training with the health services provider,
and
(b) a fixed-term employee of the health services provider, and a reference to an employee, in relation to a health services provider, shall be construed as a reference to an employee employed by that health services provider;
“employment agency” has the meaning assigned to it by the Employment Agency Act 1971;
“fixed-term employee” means an employee of a health services provider whose employment is governed by a contract of employment for a fixed-term or for a specified purpose, being a purpose of a kind that the duration of the contract was limited but was, at the time of its making, incapable of precise ascertainment;
“health practitioner” means—
(a) a registered medical practitioner within the meaning of the Act of 2007 or a medical practitioner practising medicine pursuant to section 50 of that Act,
(b) a registered dentist within the meaning of the Act of 1985,
(c) a registered pharmacist, or registered pharmaceutical assistant, within the meaning of the Pharmacy Act 2007,
(d) a registered nurse, or registered midwife, within the meaning of the Act of 2011,
(e) a registrant within the meaning of section 3 of the Act of 2005, or
(f) a person whose name is entered in the register referred to in Article 4(s) of the Order of 2000;
“health service” means a health or personal social service (including personal care and any ancillary matter relating to the health or personal social service) provided to a patient—
(a) for—
(i) the screening, preservation or improvement of the health of the patient, or
(ii) the prevention, diagnosis, treatment or care of an illness, injury or health condition of the patient,
and
(b) by or under the direction of a health services provider;
“health services provider” means—
(a) a person, other than a health practitioner, who provides one or more health services and for that purpose—
(i) employs a health practitioner for the provision (whether for, or on behalf of, that person) by that practitioner, of a health service,
(ii) enters into a contract for services with a health practitioner for the provision (whether for, or on behalf of, that person) by that health practitioner of a health service,
(iii) enters into an agency contract for the assignment, by an employment agency, of an agency health practitioner to provide a health service for, or on behalf of, that person,
(iv) enters into an arrangement with a health practitioner—
(I) for the provision by that health practitioner of a health service (whether for, or on behalf of, that person, or through or in connection with that person),
(II) for the provision by that health practitioner of a health service on his or her own behalf (whether through or in connection with, or by or on behalf of, that person or otherwise), or
(III) without prejudice to the generality of clause (II), to provide that health practitioner with privileges commonly known as practising privileges (whether such privileges are to operate through or in connection with, or by or on behalf of, the person or otherwise),
or
(v) insofar as it relates to the carrying on of the business of providing a health service—
(I) employs one or more persons,
(II) enters into a contract for services with one or more persons,
(III) enters into an agency contract for the assignment of an agency worker,
or
(IV) enters into an arrangement with one or more persons, in respect of the carrying on of that business,
or
(b) a health practitioner who, or a partnership which, provides a health service and does not provide that health service for, or on behalf of, or through or in connection with (whether by reason of employment or otherwise), a person referred to in paragraph (a) and includes a health practitioner who, or a partnership which—
(i) employs another health practitioner for the provision (whether for, or on behalf of, the first-mentioned health practitioner or the partnership) by that other health practitioner of a health service,
(ii) enters into a contract for services with another health practitioner for the provision (whether for, or on behalf of, the first-mentioned health practitioner or the partnership) by that other health practitioner, of a health service,
(iii) enters into an agency contract for the assignment, by an employment agency, of an agency health practitioner to provide a health service for, or on behalf of, the first-mentioned health practitioner or the partnership, or
(iv) insofar as it relates to the carrying on of the business of providing a health service—
(I) employs one or more persons,
(II) enters into a contract for services with one or more persons,
(III) enters into an agency contract for the assignment of an agency worker,
or
(IV) enters into an arrangement with one or more persons, in respect of the carrying on of that business;
“making an open disclosure” shall be construed in accordance with section 9;
“Minister” means the Minister for Health;
“open disclosure of a patient safety incident” shall be construed in accordance with section 9 and references to the open disclosure of a patient safety incident or open disclosure, in relation to a patient safety incident, shall be construed accordingly;
“open disclosure meeting” has the meaning assigned to it by section 16;
“Order of 2000” means the Pre-Hospital Emergency Care Council (Establishment) Order 2000 (S.I. No. 109 of 2000) amended by the Pre-Hospital Emergency Care Council (Establishment) Order 2000 (Amendment) Order 2004 (S.I. No. 575 of 2004);
“partnership” means 2 or more health practitioners who provide a health service in common;
“patient” means, in relation to a health services provider, a person to whom a health service, is, or has been, provided;
“patient safety incident” shall be construed in accordance with section 8;
“prescribed” means prescribed by regulations made by the Minister under this Part;
“principal health practitioner”, in relation to a patient, means a health practitioner who has the principal clinical responsibility for the clinical care and treatment of the patient;
“relevant person”, in relation to a patient, means a person—
(a) who is—
(i) a parent, guardian, son or daughter,
(ii) a spouse, or
(iii) a civil partner (within the meaning of the Act of 2010), of the patient,
(b) who is cohabiting with the patient (including a cohabitant within the meaning of Part 15 of the Act of 2010), or
(c) 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.
(2) References in this Part to—
(a) “information provided”, or an “apology made”, at an open disclosure meeting,
(b) “additional information provided”, or “apology made”, at an additional information meeting, or
(c) information provided in a clarification under section 19, include information that is provided, or an apology that is made, orally or in writing.
(3) For the purposes of paragraph (b) of the definition of “health services provider”, references in that paragraph to “through or in connection with” do not include the use by a health services provider referred to in that paragraph of a health service (or processes related to a health service) provided—
(a) by a health services provider referred to in paragraph (a) of that definition, and
(b) for the purpose of the provision, by a health services provider referred to in paragraph (b) of that definition, of health services on its own behalf (including, as the case may be, on behalf of a partnership).”.

This is the second group of amendments, amendments Nos. 3 and 4. This grouping is concerned with the definitions surrounding the concept and process of open disclosure in Part 4. Amendment No. 3 inserts section 7, which is the general definitions section for Part 4. Senators will notice that "health service" and "health services providers" have been defined extensively to ensure that the definitions capture the full range of health services providers available in Ireland, both on the public and private sides. Another key definition is "relevant person" which, in relation to a patient, is a person closely connected to the patient who may be present at any open disclosure meeting. The person can be a spouse, civil partner, cohabitant, parent, son or daughter or could be someone the patient has nominated in writing.

Amendment No. 4 inserts section 8, which defines the key concept of "patient safety incident" separately, thus highlighting its importance to the operation of Part 4. The definition follows the accepted international classification and nomenclature used in the World Health Organization Conceptual Framework for the International Classification of Patient Safety. The definition covers three things: the actual adverse events where harm is caused to the patient; no harm events, which are incidents that could have caused harm but did not do so; and near misses, which are outcomes that did not reach the patients but would have caused harm if they had.

Amendment agreed to.
Government amendment No. 4:
In page 14, after line 15, to insert the following:
“Meaning of “patient safety incident”
8. In this Part, “patient safety incident”, in relation to the provision of a health service to a patient by a health services provider, means—
(a) 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,
(b) an incident—
(i) 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
(ii) 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
(c) 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.”.
Amendment agreed to.

Amendments Nos. 5, 6 and 7 are related and may be discussed together by agreement. Is that agreed? Agreed.

Government amendment No. 5:
In page 14, after line 15, to insert the following:
“CHAPTER 2
Open disclosure of a patient safety incident
Open disclosure of patient safety incident
9. Where a health services provider discloses, in accordance with this Part, at an open disclosure meeting, to—
(a) a patient that a patient safety incident has occurred in the course of the provision of a health service to him or her,
(b) a relevant person that a patient safety incident has occurred in the course of the provision of a health service to the patient concerned, or
(c) a patient and a relevant person that a patient safety incident has occurred in the course of the provision of a health service to the patient,
that disclosure shall be treated as an open disclosure by the health services provider of that patient safety incident and section 10 shall apply to—
(i) the information, in respect of the patient safety incident, provided to the patient or relevant person (or both of them) at the open disclosure meeting, additional information provided at the additional information meeting and information provided in a clarification under section 19,
(ii) an apology, in respect of the patient safety incident, where an apology is made at that meeting, or the additional information meeting.”.

I will now focus on the third grouping of amendments. This grouping describes what an open disclosure is for the purposes of the Bill, what its legal effect is and the statement that is to be prepared by health services providers regarding open disclosure.

Amendment No. 5 inserts section 9 into the Bill, which provides that a disclosure of a patient safety incident made in accordance with the legislation will be considered an open disclosure.

Amendment No. 6 inserts section 10 into the Bill, which provides for certain protections for open disclosure, which will only be given when all the requirements in the legislation are met. The protections are as follows: information provided, and an apology where it is made, in an open disclosure meeting will not constitute an express or implied admission of fault or liability in a clinical negligence action regarding that patient safety incident; information provided, and an apology where it is made, in an open disclosure meeting are not admissible as evidence of fault or liability in a clinical negligence action regarding that patient safety incident; and information provided, and an apology where it is made, in an open disclosure meeting are not admissible as evidence of fault in professional fitness to practise proceedings. Section 10 also provides that insurance or indemnity is not affected by an apology made as part of an open disclosure.

Amendment No. 7 inserts section 11 into the Bill, which provides that a health services provider will prepare a written statement outlining the procedure for making an open disclosure and the restrictions on the use that the patient may make of any information provided and any apology made. I would stress at this point that the patient's medical record will still be fully accessible for use by patients and nothing in Part 4 affects that.

Amendment agreed to.
Government amendment No. 6:
In page 14, after line 15, to insert the following:
“Open disclosure: information and apology not to invalidate insurance; constitute admission of liability or fault; or not to be admissible in proceedings
10. (1) Information provided, and an apology where it is made, to a patient or a relevant person (or both of them) by a health services provider at an open disclosure meeting in respect of a patient safety incident, or pursuant to the provisions specified in subsection (3), the statement referred to in section 16(5) and the statements referred to in the provisions specified in subsection (3)—
(a) shall not constitute an express or implied admission of fault or liability by—
(i) that health services provider,
(ii) an employee of that provider (whether the employee is a health practitioner or otherwise),
(iii) a health practitioner who provides, or provided, a health service—
(I) for, or on behalf of, that provider pursuant to a contract referred to in subparagraph (ii) of paragraph (a) or (b) of the definition of “health services provider”, or
(II) for, or on behalf of, or through or in connection with, that provider pursuant to an arrangement referred to in subparagraph (iv) of paragraph (a) of that definition,
(iv) an agency health practitioner who provides, or provided, a health service for, or on behalf of, that provider,
(v) 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,
(vi) an agency worker assigned to that provider pursuant to an agency contract, or
(vii) a person who enters into a contract or arrangement, referred to in—
(I) subparagraph (v) of paragraph (a) of the definition of “health services provider”, or
(II) subparagraph (iv) of paragraph (b) of that definition,
with a health services provider,
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,
(b) shall not, notwithstanding any other enactment or rule of law, be admissible as evidence of fault or liability of—
(i) that health services provider,
(ii) an employee of that provider (whether the employee is a health practitioner or otherwise),
(iii) a health practitioner referred to in paragraph (a)(iii),
(iv) an agency health practitioner referred to in paragraph (a)(iv),
(v) a health practitioner referred to in paragraph (a)(v),
(vi) an agency worker referred to in paragraph (a)(vi), or
(vii) a person who enters into a contract or arrangement, referred to in—
(I) subparagraph (v) of paragraph (a) of the definition of “health services provider”, or
(II) subparagraph (iv) of paragraph (b) of that definition,
with a health services provider,
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, and
(c) shall not, notwithstanding—
(i) any provision to the contrary in—
(I) a policy of professional indemnity insurance,
(II) any documentation that comprises an offer, or evidence, of an arrangement for indemnity between a medical defence organisation and a member of that organisation, or
(III) a contract of insurance providing insurance cover for claims in respect of civil liability or clinical negligence actions,
and
(ii) any other enactment or rule of law,
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.
(2) Information provided, and an apology where it is made, to a patient or a relevant person (or both of them) by a health services provider at an open disclosure meeting in respect of a patient safety incident or pursuant to the provisions specified in subsection (3), the statement referred to in section 16(5) and the statements referred to in the provisions specified in subsection (3)—
(a) shall 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 determination of—
(i) a complaint under section 57 of the Act of 2007,
(ii) an application under section 38 of the Act of 1985,
(iii) a complaint within the meaning of section 33 of the Pharmacy Act 2007,
(iv) a complaint under section 55 of the Act of 2011,
(v) a complaint under section 52 of the Act of 2005, and
(vi) an allegation referred to in Article 37 of the Order of 2000,
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
(b) are not, notwithstanding any other enactment, 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).
(3) This section shall—
(a) in accordance with section 18(10), apply to—
(i) additional information provided, and an apology where it is made, at the additional information meeting, and
(ii) a statement referred to in section 18(6),
and
(b) in accordance with section 19(8), apply to information and statements provided in a clarification referred to in, and given under, that section.
(4) In this section—
“clinical negligence” means anything done or omitted to be done in the provision of a health service by a health services provider in circumstances which could give rise to liability for damages for negligence in respect of personal injury or death;
“clinical negligence action” means an action for the recovery of damages brought—
(a) by or on behalf of a person alleging that he or she, or a deceased person of whom he or she is a personal representative, has suffered personal injury or death as a result of clinical negligence, and
(b) against the health services provider alleged to have committed the act or omission giving rise to liability or any other person alleged to be liable in respect of that act or omission;
“medical defence organisation” means a body corporate, or an unincorporated body, which provides professional indemnity insurance, on a discretionary or other basis, to a member of that body in relation to an incident of clinical negligence which gives rise to a claim against a member of that body;
“professional indemnity insurance” means a policy of indemnity insurance to cover claims by or on behalf of a patient (or a relevant person) in respect of any description of civil liability for injury, harm or death that is incurred in the provision of a health service (including the carrying on of the business of the provision of a health service).”.
Amendment agreed to.
Government amendment No. 7:
In page 14, after line 15, to insert the following:
“Statement in relation to open disclosure procedure and application of section 10 to
information and apology
11. (1) A health services provider shall prepare a statement in writing of—
(a) the procedure for making an open disclosure of a patient safety incident pursuant to, and in accordance with, this Part, and
(b) the manner in which section 10 applies to the restrictions on the use, pursuant to this Part, of information provided, and any apology made, at the open disclosure meeting, the additional information meeting, or the information provided in a clarification under section 19 and any statements in writing provided in respect of those meetings or that clarification.
(2) The Minister may make guidelines in respect of the form of the statement referred to in subsection (1).”.
Amendment agreed to.

Amendments Nos. 8 to 11, inclusive, 13 and 16 are related and may be discussed together by agreement. Is that agreed? Agreed.

Government amendment No. 8:
In page 14, after line 15, to insert the following:
“CHAPTER 3
Making of open disclosure of patient safety incident
Voluntary open disclosure of patient safety incident
12. 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, in accordance with this Part, an open disclosure of the patient safety incident to—
(a) the patient concerned,
(b) a relevant person where—
(i) 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 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 the relevant person and not to the patient,
or
(c) both the patient and a relevant person where—
(i) 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 relevant person, or
(ii) 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 relevant person as well as that patient.”.

This grouping sets out the steps in the open disclosure process, from when the health services provider first becomes aware of a patient safety incident to the organisation of the meeting itself, and includes what happens when a patient decides not to take part in the process or if the health services provider cannot get in touch with the patient.

Amendment No. 8 inserts section 12 into the Bill, which provides that a health services provider may make an open disclosure regarding a patient safety incident to a patient and-or his or her relevant person.

Amendment No. 9 inserts section 13 into the Bill, which provides for who makes the disclosure on behalf of a health services provider. It will generally be the principal health practitioner involved in the patient’s care. If the principal health practitioner is unavailable, another health practitioner who the health services provider considers appropriate will make the disclosure.

Amendment No. 10 inserts section 14 into the Bill, which deals with the timing of an open disclosure meeting, which should take into the account the circumstances of the meeting, including the desirability of the open disclosure being made as soon as practicable. The meeting can go ahead even if not all of the information is available at the time.

Amendment No. 11 inserts section 15 into the Bill, which provides for matters to be addressed by a health services provider before making an open disclosure. Matters to be addressed include: to whom the open disclosure should be made, whether it should be a patient or a relevant person or both; whether it is appropriate for an apology to be made; taking steps to ensure the information is given in as clear a manner as possible; and designating a person to liaise with the patient regarding the open disclosure.

Amendment No. 13 inserts section 17 into the Bill, which provides for what happens when a patient or relevant person declines to participate in a proposed open disclosure meeting. It is important to note that there is no obligation on them to agree to participate.

Amendment No. 16 inserts section 20 into the Bill, which provides for what happens when a health services provider cannot contact a patient to arrange an open disclosure meeting. A health services provider should take all steps reasonably open to them to get in touch with a patient to arrange an open disclosure meeting.

Amendment agreed to.
Government amendment No. 9:
In page 14, after line 15, to insert the following:
“Making of open disclosure of patient safety incident by health services provider
13. (1) The open disclosure of a patient safety incident shall be made on behalf of a health services provider by—
(a) 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, or
(b) where the conditions specified in subsection (2) are satisfied, a health practitioner referred to in that subsection.
(2) Where, for the purposes of subsection (1)—
(a) the principal health practitioner referred to in paragraph (a) of that subsection is not available or otherwise not in a position to make the open disclosure of the patient safety incident, or
(b) having had regard to the circumstances of the patient safety incident, the health services provider, or the principal health practitioner referred to in paragraph (a) of that subsection, is satisfied that the open disclosure of that incident should be made by another health practitioner,
the open disclosure of that patient safety incident shall be made by a health practitioner whom the health services provider, having considered the patient safety incident concerned, considers appropriate.”.
Amendment agreed to.
Government amendment No. 10:
In page 14, after line 15, to insert the following:
“Time of making of open disclosure
14. (1) Where a health services provider has reasonable grounds for believing that a patient safety incident has occurred, the health services provider concerned shall make the open disclosure of that patient safety incident at a time it considers to be appropriate
having regard to—
(a) the desirability, subject to paragraphs (b) and (c), of making the open disclosure as soon as practicable notwithstanding that—
(i) some, or all, of the likely consequences of the patient safety incident are not present or have not developed, and
(ii) 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,
(b) all the circumstances of the patient and the nature, and consequences, of the patient safety incident concerned, and
(c) the requirements of section 15.
(2) Having considered the appropriate time for making the open disclosure of the patient safety incident, the health services provider shall take all steps reasonably open to it to make the open disclosure as soon as practicable following that consideration.
(3) Where an open disclosure of a patient safety incident is not made as soon as practicable after the consideration referred to in subsection (2), nothing in this Part shall be construed as preventing section 10 from having effect in respect of that open disclosure of the patient safety incident.
(4) Nothing in this Part shall be construed as preventing a health services provider from making an open disclosure of a patient safety incident if none, or not all, of the likely consequences of the patient safety incident have presented or have developed.”.
Amendment agreed to.
Government amendment No. 11:
In page 14, after line 15, to insert the following:
“Matters to be addressed by health services provider before making open disclosure of patient safety incident
15. (1) Before making an open disclosure of a patient safety incident, a health services provider shall—
(a) in order to determine the appropriate time at which to make the open disclosure to the patient or relevant person (or both of them) and having regard to paragraph (a) of section 14(1)—
(i) make an assessment of all the circumstances of the patient and the nature of the patient safety incident concerned, and
(ii) 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,
(b) determine, subject to subsection (4), whether the open disclosure of the patient safety incident concerned is to be made to the patient or the relevant person (or both of them), having had regard to—
(i) the assessment referred to in paragraph (a)(i),
(ii) the nature of the patient safety incident, and
(iii) consultations, if any, referred to in paragraph (a)(ii),
(c) 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 relevant person (or both of them) at the open disclosure meeting,
(d) 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,
(e) designate, subject to subsection (2), a person to liaise with the health services provider and the patient or relevant person (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 under section 19, and
(f) make arrangements for the preparation of the statement in writing, referred to in section 16(5), that is to be provided to the patient or relevant person (or both of them) at the open disclosure meeting.
(2) For the purpose of making a designation under subsection (1)(e), where the health services provider making the designation is a health services provider referred to in—
(a) paragraph (a) of the definition of “health services provider”, that health services provider may designate—
(i) an employee of that provider, including an employee who is a health practitioner,
(ii) a health practitioner who provides a health service for that provider pursuant to a contract referred to in subparagraph (ii) of paragraph (a) of that definition,
(iii) a person with whom that provider has entered into a contract referred to in subparagraph (v)(II) of paragraph (a) of that definition,
(iv) an agency health practitioner who provides a health service for that provider pursuant to an agency contract referred to in subparagraph (iii) of paragraph (a) of that definition, or
(v) an agency worker,
as the designated person in relation to the patient safety incident concerned, or
(b) paragraph (b) of the definition of “health services provider”, that provider may designate—
(i) himself or herself,
(ii) the health practitioner providing the clinical care and treatment to the patient concerned,
(iii) an employee of that provider, including an employee who is a health practitioner,
(iv) a health practitioner who provides a health service for that provider pursuant to a contract referred to in subparagraph (ii) of paragraph (b) of that definition,
(v) a person with whom that provider has entered into a contract referred to in subparagraph (iv)(II) of paragraph (b) of that definition,
(vi) an agency health practitioner who provides a health service for that provider pursuant to an agency contract referred to in subparagraph (iii) of paragraph (b) of that definition,
(vii) an agency worker, or
(viii) a partner of the health practitioner referred to in subparagraph (i),
as the designated person for the purposes of subsection (1)(e).
(3) A designation under subsection (1)(e) shall be in writing and shall be kept in the records, referred to in section 21, relating to the open disclosure of the patient safety incident made under this Part.
(4) Paragraph (b) of subsection (1) shall not apply where an open disclosure of a patient safety incident is made to a relevant person pursuant to section 12(b)(ii) or 12(b)(iii), as the case may be.”.
Amendment agreed to.

Amendments Nos. 12, 14 and 18 are related and may be discussed together by agreement. Is that agreed? Agreed.

Government amendment No. 12:
In page 14, after line 15, to insert the following:
“Open disclosure meeting
16. (1) A health services provider shall, subject to section 15, 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 making an open disclosure of a patient safety incident in respect of which the patient, or patient to whom the relevant person is connected, is the subject (in this Part referred to as an “open disclosure meeting”).
(2) When making an open disclosure of a patient safety incident at an open disclosure meeting, a health services provider—
(a) shall provide the patient, or the relevant person (or both of them), with the information specified in subsection (3), which, having regard to section 14, the health services provider has in its possession at the time the open disclosure meeting is held,
(b) may provide the information specified in subsection (3)—
(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,
(c) shall give the patient or the relevant person (or both of them) a copy of the statement in writing referred to in subsection (5) or, in the case of an open disclosure meeting referred to in subsection (1)(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, and
(d) shall provide the statement referred to in section 11(1) to the patient or relevant person (or both of them) or, in the case of an open disclosure meeting referred to in subsection (1)(b), shall deliver that statement to the patient or relevant person (or both of them) as soon as practicable after the meeting.
(3) The information referred to in subsection (2) to be provided in accordance with that subsection shall be as follows:
(a) the names of the persons present at the open disclosure meeting;
(b) a description of the patient safety incident concerned;
(c) the date on which—
(i) the patient safety incident occurred, and
(ii) the patient safety incident came to the notice of the health services provider;
(d) the manner in which the patient safety incident came to the notice of the health services provider;
(e) 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;
(f) where the health services provider has reasonable grounds for believing that, in addition to the consequences referred to in paragraph (e), further physical or psychological consequences of the patient safety incident are likely to present or develop, information in respect of—
(i) 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
(ii) 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;
(g) 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;
(h) where, at the time of the open disclosure meeting—
(i) any physical or psychological consequences arising from the patient safety incident have presented, or developed, and
(ii) the patient is under the clinical care of the health services provider concerned,
the health services provider shall 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;
(i) having regard to the consideration, by the health services provider, of the patient safety incident—
(i) the actions the health services provider has taken, or proposes to take, and
(ii) 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.
(4) Where, pursuant to paragraph (c) of section 15(1), the health services provider has determined that an apology is to be made to the patient or the relevant person (or both of them), the health services provider concerned may, at the open disclosure meeting, make the apology to the patient or the relevant person (or both of them) in respect of that patient safety incident.
(5) The statement in writing referred to in subsection (2)(c) that is to be given to the patient or the relevant person (or both of them) in accordance with that subsection shall—
(a) be in the prescribed form,
(b) set out the information, specified in subsection (3), provided to the patient or the relevant person (or both of them) in accordance with subsection (2),
(c) contain an apology referred to in subsection (4) where such apology was made,
(d) specify the day on which the open disclosure of the patient safety incident was made, and
(e) be signed in accordance with subsection (6).
(6) The statement in writing referred to in subsection (5), shall be signed by—
(a) the principal health practitioner, or
(b) the health practitioner referred to in section 13(2),
who made the open disclosure of the patient safety incident on behalf of the health services provider.
(7) The health services provider shall keep, in the records referred to in section 21, the statement referred to in subsection (5).”.

This group of amendments deals with the open disclosure meeting itself and the subsequent engagement between the health services provider and the patient concerning the patient safety incident that was the subject of the open disclosure in terms of the provision of further information or clarification of information already provided.

Amendment No. 12 inserts section 16 into the Bill, which provides for the open disclosure meeting itself, specifying what information must be provided at the open disclosure meeting as well as the manner in which that information and, where appropriate, an apology is to be made and specifying that a statement in writing containing the information provided must be given to the patient or relevant person.

Amendment No. 14 provides for a situation where further information may become available after the open disclosure meeting. The amendment inserts section 18 into the Bill, which provides for the provision of any new information, given pro-actively by the health services provider to the patient and or relevant person.

Amendment No. 15 takes into account a situation which is likely to arise where a patient may have questions following an open disclosure meeting. The amendment inserts section 19 into the Bill, which provides for how requests for clarification of information already provided by the health services provider are to be addressed.

The protections inserted under amendment No. 6 also apply to clarification of information and further information provided under the sections inserted by amendments Nos. 14 and 15.

Amendment agreed to.
Government amendment No. 13:
In page 14, after line 15, to insert the following:
“Refusal, by patient or relevant person, to participate in open disclosure of patient safety incident
17. (1) Nothing in this Part shall require a patient or a relevant person, or where section 12(c) applies, both of them, to engage with the health services provider in the open disclosure of a patient safety incident.
(2) Where a health services provider informs a patient or a relevant person that the provider proposes to hold an open disclosure meeting and the patient or relevant person does not want to attend that open disclosure meeting, the patient or relevant person shall inform that provider that he or she—
(a) will not attend the open disclosure meeting,
(b) does not wish to receive the information which is to be provided at that meeting, and
(c) does not wish to receive, having regard to section 14(1)(a) and section 14(4), any additional information that may be provided (or apology, that may be made) pursuant to section 18.
(3) Where a patient or a relevant person, or as the case may be both of them, informs a health services provider of the matters specified in subsection (2), the provider shall—
(a) set out a statement in writing, in the prescribed form, of those matters,
(b) sign that statement and specify the date on which it was signed,
(c) provide the patient, relevant person 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,
(d) maintain the statement which has, in accordance with paragraph (b) been signed by the provider, in the records referred to in section 21, and
(e) pursuant to that statement, not proceed to hold the open disclosure meeting.
(4) Where, in accordance with section 12(c), a health services provider informs both a patient and a relevant person that the provider proposes to hold an open disclosure meeting and both the patient and relevant person do not want to attend that open disclosure meeting, the patient and relevant person shall inform that provider that—
(a) they will not attend the open disclosure meeting,
(b) they do not wish to receive the information which is to be provided at that meeting, and
(c) they do not wish to receive, having regard to section 14(1)(a) and section 14(4), any subsequent information that may be provided (or apology that may be made) pursuant to section 18.
(5) Where, in accordance with subsection (4), a patient and a relevant person informs a health services provider of the matters specified in that subsection, the provider shall—
(a) set out a statement in writing, in the prescribed form, of those matters,
(b) sign that statement and specify the date on which it was signed,
(c) provide the patient and the relevant person who has informed the provider of those matters with a copy of that statement which has, in accordance with paragraph (b) been signed by the provider, as soon as practicable,
(d) maintain the signed statement which has, in accordance with paragraph (b) been signed by the provider, in the records referred to in section 21, and
(e) pursuant to that statement, not proceed to hold the open disclosure meeting.
(6) Where a patient, or a relevant person, refuses to accept the statement referred to in—
(a) paragraph (c) of subsection (3), or
(b) paragraph (c) of subsection (5),
the provider shall—
(i) make a note in writing, in the prescribed form, of that refusal,
(ii) sign the note referred to in paragraph (i) and specify the date of signing, and
(iii) keep, in the records referred to in section 21, the note referred to in subparagraph (i), which has been signed in accordance with subparagraph (ii).”.
Amendment agreed to.
Government amendment No. 14:
In page 14, after line 15, to insert the following:
“Provision of additional information at additional information meeting
18. (1) A health services provider may, at any time after the holding of the open disclosure meeting, provide information that is additional to the information, specified in section 16(3), which was, in accordance with section 16(2)(a), provided to the patient or relevant person (or both of them) at the open disclosure meeting (“additional information”) that, having regard to—
(a) subparagraphs (i) and (ii) of paragraph (a) of section 14(1), and
(b) section 14(4),
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).”.
Amendment agreed to.
Government amendment No. 15:
In page 14, after line 15, to insert the following:
“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).”.
Amendment agreed to.
Government amendment No. 16:
In page 14, after line 15, to insert the following:
“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.”.
Amendment agreed to.
Government amendment No. 17:
In page 14, after line 15, to insert the following:
“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.”.

Amendment No. 17 inserts section 21, which requires that a health services provider keeps records of specific matters relating to open disclosure, including written statements given to the patients. The keeping of appropriate and proper records is considered very important.

Amendment agreed to.
Government amendment No. 18:
In page 14, after line 15, to insert the following:
“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.”.

This is a standard provision. Amendment No. 18 inserts section 22, which provides that the Minister for Health may by regulations provide for matters relevant to Part 4 that are specified as prescribed or to be prescribed. This regulation-making power will help to ensure consistency in the open disclosure process, particularly as regards standardising forms to be used.

Amendment agreed to.
Government amendment No. 19:
In page 14, after line 15, to insert the following:
“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.”.

Amendment No. 19 inserts section 23, which is a saving and transitional provision. It provides that Part 4 will 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 the Part. Where a patient safety occurred or came to the notice of the health services provider before the commencement of the legislation, the provider may still make an open disclosure in accordance with the legislation. For completeness, it also provides how "as soon as practicable" is to be interpreted in such a situation.

Amendment agreed to.
TITLE
Government amendment No. 20:
In page 3, line 9, after “2004;” to insert the following:
“to make provision for the making, by health services providers, of the open disclosure of patient safety incidents; to provide, in the interest of the common good, for certain restrictions on the use of information provided in an open disclosure of a patient safety incident that is made by a health services provider in accordance with this Act, the use of any apologies made in that open disclosure and the use of any other information relating to the open disclosure provided, and apology made, after the open disclosure meeting;”.

Amendment No. 20 amends the Long Title of the Bill to include the open disclosure provisions. It is a necessary consequential amendment. I hope that Senators will agree that these new provisions are timely and important. As Members of the House will be aware, Ireland's patient safety record has been compromised by a number of high-profile events and reports over the last three years which have affected public confidence in the health service. We have also seen that on occasions, patients and their families have felt unsupported by the system, have not been afforded adequate explanations following adverse events or have found the health service complex to navigate. These provisions mark a major step forward in creating a different mindset within the health service. Through the creation of a culture of open disclosure and emphasising the need to learn from the things that go wrong, we will see a safer health service emerge.

The open disclosure provisions form part of a number of initiatives to improve the management of patient safety incidents. HIQA and the Mental Health Commission are at an advanced stage of development of standards on the conduct of reviews of patient safety incidents which expand on the national standards for safer and better healthcare. This set of standards, along with the mandatory reporting of serious reportable events provided for in the Health Information and Patient Safety Bill and the provisions intended for open disclosure will provide a comprehensive patient-centred approach to preventing, managing and learning from incidents. Delivery of health care is inherently risky. While it is inevitable that things will go wrong, there is much that can be done to prevent harm or error, identify and act on when it occurs and to learn from this to improve services.

As I have outlined earlier the provisions for open disclosure form part of the broad and ambitious programme of patient safety reforms being progressed by the Minister for Health. This programme of reform is aimed at a whole systems approach to improving patient safety.

Amendment agreed to.
Title, as amended, agreed to.
Bill reported with amendments.

When is it proposed to take Report Stage?

Report Stage ordered for Tuesday, 11 April 2017.
Sitting suspended at 1.15 p.m. and resumed at 3 p.m.