Requirements Relating to the Form, Content and Quality Standards of an Application
Pursuant to section 54 (5) of the Health Practitioners Competence Assurance Act 2003 ("the Act"), this notice sets out requirements relating to the form, content and quality standards of an application to have a quality assurance activity
(QAA) protected.
Introduction
Sections 52 to 63 of the Act provide for the confidentiality of information collected as part of a protected quality assurance process in relation to health practitioners registered under that Act. It is based on the underlying principle that there is benefit to the public from QAAs in relation to health services provided by those practitioners. There are benefits to the public through improvements in the competence and practice of health practitioners whether by QAAs or otherwise. There is a public interest test that is applied to each application to ensure that a QAA is a suitable mechanism to achieve those improvements.
Section 53 of the Act defines a QAA as an activity that is undertaken to improve the practices or competence of one or more health practitioners by assessing the health services performed by those health practitioners (whenever those services are or were performed); and includes the following acts done in the course of, or as a result of, that activity:
(i) The whole or part of any assessment or evaluation;
(ii) the whole or part of a study of the incidence or causes of conditions or circumstances that may affect the quality of health services performed by one or more of those health practitioners;
(iii) any preparation for that assessment, evaluation, or study;
(iv) making recommendations about the performance of those services; and
(v) monitoring the implementation of those recommendations.
The methodology described in the notice that the Minister of Health formally signs can incorporate a number of separate activities that collectively make up the "activity" to be protected.
Content and Quality Standards of an Application
The application form to have a QAA declared "protected" is set out below.
The form is designed to ensure that applications:
1. Provide a title and description of the QAA.
2. Outline the purposes of the QAA.
3. Sufficiently identify the group of health practitioners who are involved in the QAA.
4. Describe the method by which the activity will be carried out.
5. Identify the procedures that will be undertaken to improve the practices and competence of the health practitioners if the activity identifies problems in the provision of any health services provided by health practitioner/s.
6. Identify the processes for providing meaningful feedback to participating practitioners.
7. Provide the name, description and official address of the body or organisation under which the QAA will be carried out.
8. Provide the name and position of the person to be "responsible" for the activity.
9. Explain clearly why it is in the public interest that the activity be declared.
In addition, the nominated responsible person must undertake to provide the reports on the activity required by the Act to be provided to the Minister of Health and to the provider of health services whose employees and agents participate in the activity.
Application Form
Application for Declaration of Protected Quality Assurance Activities Under the
Health Practitioners Competence Assurance Act 2003
This application form must be used and is intended to provide sufficient information to assess whether the Minister of Health should exercise the discretion to declare a quality assurance activity (QAA) to be a protected QAA.
1 What is the title and description of the QAA?
The title and description should precisely identify the QAA sought to be declared as "protected". The QAA can be described by one or more of the following ways:
(a) By reference to the nature of the activity;
(b) by reference to a person [or group of people] engaging in, or proposing to engage in, the activity; and/ or
(c) by reference to circumstances in which the activity is being, or is proposed to be, engaged in.
2 What are the purposes of this QAA?
Describe all purposes in detail. This information is needed so that a notice can describe a QAA accurately. The purpose of the activity must fit the definition of a QAA in section 53 of the Health Practitioners Competence Assurance Act 2003.
Section 53 (1) contains the following definition:
quality assurance activity -
(a) means an activity that is undertaken to improve the practices of one or more health practitioners by assessing the health services performed by those health practitioners (whenever those services are or were performed); and
(b) includes the following acts that are done in the course of, or as a result of, that activity:
(i) The whole or part of any assessment or evaluation:
(ii) the whole or part of a study of the incidence or causes of conditions or circumstances that may affect the quality of health services performed by one or more of those health practitioners:
(iii) any preparation for that assessment, evaluation, or study:
(iv) making recommendations about the performance of those services:
(v) monitoring the implementation of those recommendations.
3 Who are the participants?
This is not intended to require that participating practitioners necessarily be named. The question requests simply that there be sufficient identification of them - perhaps by memberships of colleges, or employment with a certain DHB, that their participation in the QAA can be guaranteed, and the QAA process can collectively or individually feed back to them advice of any recommendations for improved clinical competence. It is important that the participating practitioners are identifiable or group of practitioners is known from the outset of the QAA. This is to ensure that there is enough certainty as to who is participating so that the QAA methodology can work effectively. In some cases, it may be necessary to name individual participating practitioners, where this is the only way to identify them.
An application for a protected QAA may propose that it cover registered health practitioners of more than one profession. Such applications should document that the different professions who might be expected to participate generally support the application.
4 Describe the methodology or how the activity will be carried out
An "activity" formally described and protected under the provisions of the Act may consist of a number of separate activities, to the extent that they fall within the methodology formally described in the notice signed by the Minister of Health.
5 What procedures will be undertaken to improve the practices and competence of the participating health practitioners if the assessment or evaluation identifies problems in the provision of any health services provided by the health practitioners?
Describe the mechanisms for providing feedback and advice to the health practitioners and how it is intended to effect any changes or to introduce new processes or procedures designed to improve the provision of the relevant health services.
6 How does the proposed QAA meet the requirements of a QAA provided in the definition in section 53 of the Health Practitioners Competence Assurance Act 2003?
Identify that the QAA proposed to be protected contains the following elements:
? Identifiable group of health practitioner(s)
? Assessment or evaluation of the health services provided by that/those practitioner(s)
? Report back or recommendations to participating health practitioners about the performance of the health services provided by those practitioners, aimed at improving the practices and competence of those practitioners
? The monitoring of the implementation of any such recommendations.
There is an expectation that the competence and practice of participating practitioners will improve and that this can be measured through the operation of the QAA.
7 Who is the activity's sponsor?
The sponsor is the person or association of persons on whose initiative and under whose guidance the activity is undertaken. Give full details. A sponsor could, for example, be a department, a specialty, a Government body, a District Health Board, a licensed hospital, a body that provides health care, an educational institution, a research body or a health practitioner college.
8 What is the name and position of the responsible person for this QAA? Does the responsible person have any association with the health practitioners who performance is being assessed; if so, what?
To be appointed as a responsible person, the person must be a natural person and, in the Minister's opinion, sufficiently independent of the health practitioners whose services are to be assessed or evaluated through the QAA. In essence, the person needs to be able to take responsibility for the integrity and maintenance of the QAA's methodology and to provide independent or objective commentary or overview to meet the reporting requirements. They need not be external to your organisation, but should have a sufficient knowledge of the subject-matter of the QAA, and QAAs generally, to enable them to adequately carry out the purpose and functions of the role. While clinical knowledge may be useful, for some QAAs, particularly multi-disciplinary QAAs, a senior quality manager may be more appropriate for this role.
There is a formal requirement that the responsible person must not have been convicted in any Court in New Zealand or elsewhere of any offence punishable by imprisonment for a term of 3 months or more or been adjudged bankrupt under the Insolvency Act 1967.
The responsible person must give in writing the undertakings and declaration set out below this application form.
9 Why is it in the public interest that the protections conferred by the Health Practitioners Competence Assurance Act 2003 should apply to your activity?
The Minister may not declare a QAA unless the Minister is satisfied that it is in the public interest that the protection conferred by the provisions of the Health Practitioners Competence Assurance Act 2003 should apply in respect of that activity.


___________________ __________
Signature of Applicant Date

Undertakings and Declaration by the Responsible Person
Undertaking 1
I undertake to inform the Minister of Health of any change to the purposes of the QAA as soon as practicable after the change occurs.
Undertaking 2
I undertake to inform the Minister of Health of any significant change to the composition or purposes of the group of the participating health practitioners, if it is likely to affect the QAA, as soon as practicable after the change occurs.
Undertaking 3
I undertake to meet the obligations set out in section 58 of the Health Practitioners Competence Assurance Act 2003 relating to reporting to the relevant providers of health services and to the Minister of Health.
Declaration
I declare that I have not:
? been convicted in any Court in New Zealand or elsewhere of any offence punishable by imprisonment for a term of
three months or more; or
? been adjudged bankrupt under the Insolvency Act 1967.
(N.B.: At the Minister of Health's discretion, this declaration may be required to be given as a Statutory Declaration).


___________________________ __________
Signature of Responsible Person Date

Completed applications, and any reports or notifications given pursuant to the undertakings given by responsible persons, should be sent to:
David Dunbar
Sector Policy Directorate
Ministry of Health
P.O. Box 5013
Wellington.
Note:
The duration of a protected QAA notice may be no longer than five years. If there is a change in the nature of the activity, an amendment to the notice may be required. The Ministry of Health should be consulted. Contact the Ministry of Health at the above address to request an application form.
Every notice declaring a QAA protected is deemed to be a Regulation. This means that each notice is subject to a measure of Parliamentary scrutiny and control of the process. This includes potential scrutiny by Parliament's Regulations Review Committee. Each notice will be published in the Statutory Regulation series. The notice is a legal document.
Responsible Persons' Reporting Requirements
Section 58 (1) and (3) of the Health Practitioners Competence Assurance Act 2003 reads as follows:
58 Reporting requirements:
(1) Within two months after the expiry of each period of six months (the reporting period) that follows the date of
a notice under section 52 declaring a QAA to be protected, the person for the time being appointed to
be responsible for the activity must give each provider of health services (the provider) who has, or whose employees or agents have, been assessed in the reporting period through the activity a report relating to the reporting period that sets out information on the following matters:
(a) Any problems or issues concerning the operations of the provider that have been identified in the course of the activity;
(b) any action that has been taken, as a result of the activity, to resolve or address the problems or issues stated under paragraph (a);
(c) any recommendations that have been, or are to be, made to the provider as a result of the activity;
(d) the manner in which the implementation of the recommendations stated under paragraph (c) is to be monitored; and
(e) the manner in which improvements in the competence or practice of the provider or any of the agents or employees of the provider are to be monitored.
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(3) A report given under [this section] may not identify, either expressly or by implication, a particular individual.