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Designated Auditing Agency Handbook Ministry of Health Auditor Handbook

Ministry of Health requirements for auditing and audit reporting for certification under the Health and Disability Services (Safety) Act 2001.

Citation: Ministry of Health. 2010. Designated Auditing Agency Handbook: Ministry of Health Auditor Handbook. Wellington: Ministry of Health.

Published in February 2010 by the Ministry of Health

PO Box 5013, Wellington, New Zealand

ISBN 978-0-478-35909-1 (online) HP 5051

This document is available on the Ministry of Health’s website: http://www.moh.govt.nz

Contents

1 Introduction 1

1.1 Keeping the handbook updated online 1 1.2 Additional reading 1

2 Definitions within this Document 3

3 Types of Audits and Specific Requirements 7

3.1 Provisional audit 7 3.2 Partial provisional audit 8 3.3 Full audit (as a condition of certificate) 9 3.4 Certification audit 10 3.5 Surveillance audit 10 3.6 Verification audit 12

4 Auditing Principles 14

5 Designated Auditing Agency Responsibilities 15

6 Audit Teams 19

6.1 Team leader (lead auditor) 19 6.2 Audit team 21 6.3 Technical experts 21 6.4 Consumer auditors 22

7 Audit Process Requirements 23

7.1 Unannounced audits 23 7.2 Two-stage audit process for certification audit 23 7.3 Audit duration 24 7.4 Multiple sites 24 7.5 Auditing against conditions on a certificate 25 7.6 Evidence-based auditing 26 7.7 Interviewing 29 7.8 Collection of audit evidence 31 7.9 Analysis of audit evidence 32

8 Audit Reporting 36

8.1 Documented evidence 36 8.2 Reporting of critical and high risks 37 8.3 Submission of the Ministry of Health audit report 37 8.4 Incomplete or inadequate reports 38

Designated Auditing Agency Handbook iii

9 Audit Summary for Publication 39

9.1 Exception process 40

10 Publication of Addendums 41

11 Progress Reporting 42

11.1 Procedure 42

Appendices Appendix 1: Example Provider Declaration for DAA Use 44 Appendix 2: Auditor Competency Requirements Specific to Service Categories 48 Appendix 3: Code of Conduct for DAA Auditors 51 Appendix 4: Annual Self-declaration Form 52 Appendix 5: Progress Report Form 54 Appendix 6: Gazette Notice: ‘Designation of Auditing Agency’ 56

iv Designated Auditing Agency Handbook

Designated Auditing Agency Handbook 1

1 Introduction

The key purpose of this handbook is to state the Ministry of Health (the Ministry)’s requirements of Designated Auditing Agencies (DAAs) for auditing and audit reporting for certification of Health Care Services under the Health and Disability Services (Safety) Act 2001 (the Act). This version of the Designated Auditing Agency Handbook replaces all prior versions. This handbook will be updated periodically, and where necessary in collaboration with DAAs. If there is any doubt as to any interpretation or requirement specified within this handbook, DAAs shall request written guidance from their third-party accrediting body or from HealthCERT (a business unit within the Ministry) in advance of any action.

1.1 Keeping the handbook updated online

This handbook will be updated periodically online, in order to keep it accurate. To ensure you have the latest version please access or download the online handbook at http://www.moh.govt.nz/certification

1.2 Additional reading

a. AS/NZS ISO 19011:2003 – Guidelines for quality and/or environmental management systems auditing.

b. Code of Health and Disability Services Consumer’s Rights 1996 and the Health and Disability Services (Safety) Act 2001.

c. Health and Disability Services (General) Standards, NZS 8134.0:2008.

d. Health and Disability Services (Core) Standards, NZS 8134.1:2008.

e. Health and Disability Services (Restraint Minimisation and Safe Practice) Standards, NZS 8134.2:2008.

f. Health and Disability Services (Infection Prevention and Control) Standards, NZS 8134.3:2008.

g. IAF MD2: 2007 – International Accreditation Forum Mandatory Document for the Transfer of Accredited Certification of Management Systems.

h. IAF MD5: 2009 – International Accreditation Forum Mandatory Document for Duration of Quality Management Systems and Environmental Management Systems Audits.

i. ISO/IEC 17021:2006 Conformity assessment – requirements for bodies providing audit and certification of management systems.

j. International Society for Quality in Health Care Ltd (ISQua) Healthcare Standards, 2009.

k. Other Acts, Regulations, Codes and Guidelines relevant to the service being audited and the auditors’ practice.

http://www.moh.govt.nz/publications/guidance/DAAhandbook

Note: ISO/IEC 17021:2006 and AS/NZS ISO 19011:2003 are in the process of being revised and combined. Once ISO/IEC 17021-2:2009 is released, where reference is made to either ISO/IEC 17021 or AS/NZS ISO 19011:2003 this shall be read as ISO/IEC 17021-2:2009.

2 Designated Auditing Agency Handbook

2 Definitions within this Document

Agency A designated auditing agency.

Audit A systematic, independent, objective and documented evaluation of the extent to which health care providers meet standards and processes, based on particular audit criteria.

Audit reporting template A Ministry of Health document supplied electronically to DAAs to be completed and submitted by them as a record of the audit.

Consumer/kiritaki A person who uses or receives a health or disability service.

Corroboration/verification of evidence

The process of confirmation of conclusions by the auditor, which should occur through the triangulation of evidence wherever possible.

Critical Risk A risk that requiring immediate corrective actions, including documentation and sign-off by an auditor within 24 hours and notification to the Ministry, in the interests of consumer safety.

Designated auditing agency (DAA)

An auditing agency for the time being designated under section 32(1) of the Health and Disability Services (Safety) Act 2001.

Director-General The chief executive of the Ministry of Health.

Episode of care A period between defined intervals (for example from admission to discharge, or for the duration of specific management of an illness).

Exception reporting Documentation of any adverse event that is notifiable and may impact on the intended outcome of a practice.

Experienced Refers to a person with a minimum of two years’ experience in a particular field.

Evidence-based approach The rational method for reaching reliable and reproducible audit conclusions in a systematic audit process. This may include sampling of a subset of a population, in order to provide a representative depiction from which to be able to confidently generalise conclusions.

HDSS The Health and Disability Services Standards.

Health care services Hospital care, rest home care, residential disability care, or other specified health (including mental health) or disability services.

HealthCERT The section of the Ministry of Health responsible for the administration of the Health and Disability Services (Safety) Act 2001.

Hospital care Children’s health services, geriatric services, maternity services, medical services, mental health services or surgical services (or combinations of two or more of those services), provided:

the services are provided in premises held out by the person providing or intending to provide them as being capable of accommodating two or more of the people for whom the services are provided for continuous periods of 24 hours or longer

the services are provided in consideration of payment (whether made or to be made, and whether by the Crown, the people for whom the services are provided or any other person).

IPCS (2008) Health and Disability Services (Infection Prevention and Control) Standards.


Lead auditor/team leader/ lead auditor

The person holding a qualification in auditing assigned to managing the audit team and audit process and responsible for authorising the a final audit report prior to the report it being submitted to the Ministry of Health. The lead auditor holds a qualification in auditing that enables them to undertake the team leader role. Note that ‘team leader’ is the equivalent reference to ‘lead auditor’ in ISO 19011.

Ministry’s Disability Services

Part of the Health and Disability National Services Directorate of the Ministry of Health, responsible for the planning and funding of disability support services.

Multi-site Refers to an organisation that has a central location at which certain activities are planned, controlled or managed and a network of local offices, branches and services (sites) at which such activities are carried out.

On-site audit A physical visit by an audit team to a provider organisation to audit compliance against all standards applicable to that provider.

Problem/issue A deviation from a known standard.

RMSP Health and Disability Services (Restraint Minimisation and Safe Practice) Standards.

Residential disability care Residential care provided in any premises for five or more people with an intellectual, physical, psychiatric or sensory disability (or a combination of two or more such disabilities) to help them function independently.

Rest home care Applies to services that:

are residential care services provided for the care or support of, or to promote the independence of, people who are frail (whether because of their age or for some other reason)

neither include, nor are provided together with, geriatric services

are provided for three or more people unrelated by blood or marriage (or a relationship in the nature of marriage) to the person providing the services

are provided in premises held out by the person providing the services as being principally a residence for people who are frail because of their age

are provided in consideration of payment (whether made or to be made, and whether by the Crown, the people for whom the services are provided or any other person).

Sampling of sites A process carried out under a written, pre-negotiated agreement between a multi-site provider of residential disability care and the Ministry of Health that an agreed percentage or number of the provider’s premises/sites will be audited (note that sampling of sites does not apply to hospital care or rest home care).


Self-assessment: reconfiguration of certified services

A process undertaken by providers who are certified to provide more than one kind of service and who want to have the ability to swing bed type dependent on the residents’ needs (for example, a provider with 15 rest home-level beds and 15 hospital-level beds who wants the ability to ‘swing’ to five rest-home level beds and 25 hospital-level beds). This also applies to rest home care services wishing to also provide dementia care.

If the self-assessment rates a score of 19–23, or where the reconfiguration of services includes the addition of dementia care, a verification audit will be required by the provider’s designated auditing agency.

Service provider An individual who is responsible for performing a service either independently or on behalf of an organisation. In this definition, ‘service’ includes the provision of direct and indirect care or a support service to the consumer. ‘Service provider’ covers all service providers and management who are: employed self-employed visiting honorary sessional contracted a volunteer; or responsible or accountable to an organisation when providing a

service to a consumer.

For the purpose of auditing against the HDSS, informal/unpaid and family/whānau networks are excluded.

Site visit A physical visit by an auditor to a provider to audit applicable standards, or parts of standards. This includes verifying the implementation at each site of generic policies, procedures and systems, following a review of organisation-wide policy and procedures. HealthCERT must approve the site-sampling of particular providers before site visits may be undertaken.

Technical expert A person who provides specific knowledge or expertise to the audit team but does not act as an auditor in that team, as specified in ISO 9000:2005.

Increased capacity template

A form completed by a certified provider when that provider is proposing to increase the number of beds for a certified service (for example a provider is currently certified for 20 hospital-level beds and wishes to increase their capacity to 30 beds).

The Act The Health and Disability Services (Safety) Act 2001.

The standards (HDSS) NZS 8134.0:2008, NZS 8134.1:2008, NZS 8134:2:2008 and NZS 8134.3:2008 and any amendments or additional standards in accordance with the Act.

Tracer methodology Methodology that follows a selected consumer through a continuum of care enabling the evaluation of a service in terms of compliance with selected standards, policies and processes. In this process auditors retrace the specific care processes that a consumer experiences.

Triangulation of evidence A process of drawing information from three sources (interviews, observations and documentation) in order to gather reliable evidence.


3 Types of Audits and Specific Requirements

3.1 Provisional audit

Definition A provisional audit is undertaken to:

establish the level of preparedness of a prospective provider to provide a health and disability service

establish a level of conformity prior to a facility being purchased.

Applies to Applies to:

a new provider applying for certification of a new service

a new provider purchasing a certified service

a certified provider purchasing a certified service

Scope The audit should include:

an interview with the prospective provider (or contact person) to establish their preparedness to deliver a health and disability service

an audit of the current facility against all standards.

Provider roles and responsibilities

The provider must:

submit an application, signed declaration and prescribed fee to HealthCERT

provide a certificate of incorporation (or other relevant legal documentation of a business entity) to HealthCERT

engage a DAA to undertake the provisional audit.

DAA roles and responsibilities

The DAA must:

notify the relevant District Health Board (DHB) portfolio manager of the intention to audit where the provider holds or has applied to hold a contract for services

notify the Ministry’s Disability Services of the intention to audit where the provider holds or has applied to hold a contract for disability services

submit the audit report at least 20 working days prior to the date the provider intends to commence service delivery.

Outcome The period of certification will be for one year.

Subject to the risks identified in the provisional audit, a surveillance audit or full audit may be required after six months.

A schedule will be developed in response to the findings of the provisional audit. This will include progress reporting against moderate- to high-risk criteria (that is corrective actions required up to and including three and six months).


3.2 Partial provisional audit

Definition A partial provisional audit is undertaken to establish the level of preparedness of a certified provider to provide a new health and disability service.


a certified provider applying to add a new kind of service to an existing certificate (for example certified rest home adding a hospital)

a certified provider for residential disability services establishing a new facility of 10 beds or fewer.

Note: For any other configurations it is recommended that providers liaise directly with HealthCERT.

Scope The audit should include:

an interview with the provider (or contact person)

an audit against the following: – HDSS 1.2.1.3 – HDSS 1.2.2 (Service management) – HDSS 1.2.7 (Human resource management) – HDSS 1.2.8 (Service provider availability) – HDSS 1.3.12 (Medicine management) – HDSS 1.3.13 (Nutrition, safe food and fluid management) – HDSS 1.4.1–1.4.8 (Safe and appropriate environment) – HDSS 3.1 (Infection control management)


The provider must:

submit an application, signed declaration and prescribed fee to HealthCERT

engage a DAA to undertake the partial provisional audit.


The DAA must:

notify the relevant DHB portfolio manager of the intention to audit where the provider holds or has applied to hold a contract for services


submit the audit report at least 20 working days prior to the date the provider intends to commence service delivery

provide any additional documentation, including where relevant a copy of a current building warrant of fitness (or a certificate of public use in respect of a new site) or written advice from the relevant local authority confirming one is not required for a service currently certified; and a copy of Fire Service approval of an evacuation scheme or Fire Service notification that a scheme will not be approved until after occupation.

Outcome The period of certification will be for one year.

A schedule will be developed in response to the findings of the provisional audit. This will include progress reporting against moderate- to high-risk criteria (that is corrective actions required up to and including three and six months).


3.3 Full audit (as a condition of certificate)

Definition A full audit required as a condition of certification applies to a provider who has been initially certified prior to commencing service delivery on the basis of a provisional audit. The 12 months allowed between a provisional audit and a full audit gives the provider time to ensure all the requirements of the standards have been met.

Applies to Applies to providers who have undergone a provisional audit.

Scope The audit should meet all requirements of the HDSS.


The provider must ensure the DAA is scheduled to complete the audit as per the condition of certification.


The DAA must:



submit the audit report at least 20 working days prior to the date on the provider’s certificate

provide any additional documentation and evidence (see examples under ‘DAA roles and responsibilities’ in partial provisional audit information above).

Outcome Based on the audit report findings and other relevant information, HealthCERT will issue a new certificate and determine a period of certification.



3.4 Certification audit

Definition A certification audit is undertaken to determine if a provider is meeting the relevant service standards.

Applies to Applies to affected providers providing a health or disability service that is required to be certified under the Act.

Scope The audit should meet all relevant requirements of the HDSS NZS 8134:2008.


A certified provider must:

ensure that the certification remains current

apply for certification with HealthCERT, including a signed declaration and fee.


The DAA must:



submit the audit report at least 20 working days prior to the date on the provider’s certificate

provide any additional documentation and evidence (see examples under ‘DAA roles and responsibilities’ in partial provisional audit information above).

Note: The DAA may be required to conduct this audit at short notice on request by the Ministry.

Outcome A period of certification for up to five years may be provided (section 29(1) of the Act).

If a certificate is issued for one year, two years or three years, one surveillance audit will be required during this period (refer to section 4.5 of this document).

If a certificate is issued for four or five years, two surveillance audits will be required during this period (refer to section 4.5 of this document).

Providers who are not subject to an annual on-site surveillance audit must complete an annual self-declaration to their DAA that confirms their service continues to operate in accordance with the HDSS.1

3.5 Surveillance audit

Definition A surveillance audit is undertaken part-way through a service provider’s period of certification.

It is not a full audit against all relevant standards, but offers an overview of key aspects of service delivery.

The intent is to provide the Ministry with assurance the provider is continuing to meet all relevant standards.

The focus of the audit is on service delivery and review of criteria not fully attained at the previous audit.

All surveillance audits carried out as part of aged care residential audits must be unannounced.

1 Refer to Section 12 Appendix 1 of this document for an example of a declaration.

Applies to Applies to affected providers providing a health or disability service that is certified under the Act.

Scope A surveillance audit should include the following standards/criteria: HDSS 1.1.9.1 HDSS 1.1.13.3 HDSS 1.2.1.3 HDSS 1.2.3.2 HDSS 1.2.3.3 HDSS 1.2.3.5 HDSS 1.2.3.6 HDSS 1.2.3.7 HDSS 1.2.3.8 HDSS 1.2.3.9 HDSS 1.2.4.3 HDSS 1.2.4.4 HDSS 1.2.7.5 HDSS 1.2.8.1 HDSS 1.3.3.1 HDSS 1.3.3.2 HDSS 1.3.3.3 HDSS 1.3.3.4 HDSS 1.3.6.1 HDSS 1.3.6.4 HDSS 1.3.7.1 HDSS 1.3.7.2 HDSS 1.3.8.3 HDSS 1.3.12.1 HDSS 1.3.12.3 HDSS 1.3.12.5 HDSS 1.3.12.6 HDSS 1.3.13.1 HDSS 1.3.13.2 HDSS 2.1.4 (Restraint minimisation and safe practice) HDSS 2.1.5(e) (Restraint minimisation and safe practice) HDSS 3.5.7 (Infection prevention and control).

Additionally, it should also include all partially attained and unattained criteria identified at previous audit (certification or re-certification), and: HDSS 1.4.2.2(a) (Confirmation of a current building warrant of fitness) HDSS 1.4.2.1, 1.4.2.2(b) and 1.4.7.3 if any alterations to the building have

occurred since the last certification audit HDSS 1.3.10.1 and 1.3.10.2 for surveillance audits of mental health

services.



The DAA must:



undertake the audit not more than six weeks prior to the due date for all services as written on the schedule except aged residential care

submit the surveillance report electronically by the date given on the condition on the schedule for all services except aged residential care

notify the Ministry of the intended date of the unannounced surveillance audit at least three months prior to the audit (as part of provision of quarterly notifications to the Ministry of upcoming unannounced surveillance audits)

undertake the audit unannounced three months either side of the surveillance audit due date for aged residential care services, and submit the audit report electronically within 15 working days of the audit being completed

provide any additional documentation and evidence (see examples under ‘DAA roles and responsibilities’ in partial provisional audit information above)

widen the scope of the surveillance audit to include any aspect of the HDSS if any areas of non-compliance (actual or potential) have been identified as a result of the audit process (for example as a result of observation while conducting a tour of the service or in the review of clinical files, or in interviews with staff, consumers or relatives).

Outcome The period of certification does not change. However, a new schedule may be issued in support of partially and/or unattained criteria.

Note: A provider proposing a reconfiguration of services at the time of a surveillance audit may also be required to undergo a verification audit.

3.6 Verification audit

Definition A verification audit is undertaken to ensure a newly reconfigured service complies with the relevant standards.


certified providers when they have completed a Self-Assessment: Reconfiguration of Certified Services with a risk rating score over 19 and providers of all services where dementia care is an addition to the service (in the case of risk rating scores under 19, the DAA is requested to report on changes at the next planned audit)

providers who have completed a template notifying of increased capacity which has resulted in a risk rating score over 17 (in the case of scores under 17 the DAA is requested to report on changes at the next planned audit).

Note: both templates – Self-Assessment: Reconfiguration of Certified Services and Increasing Capacity – are on the Ministry’s website.


Scope The audit should include at least:

an interview with the manager

a site visit to the premises where the service is to be provided

audit against the following standards: – HDSS 1.2.1 – HDSS 1.2.8 – HDSS 1.3.13 – HDSS 1.4.1–1.4.8 – HDSS 3.3.


The provider must:

notify the Ministry of any planned reconfiguration or increase in capacity

complete either a Self-Assessment: Reconfiguration or an Increased Capacity template

notify the DAA if a verification audit is required.


The DAA must:



undertake the verification audit prior to occupation and on completion of the adaptation of the premises for the services

submit the audit report at least 15 working days prior to the date the provider intends to commence service delivery. It is acknowledged a certificate of public use for the building and/or a Fire Service approved fire evacuation scheme may not have been received by the provider at the time of the audit. In respect of these documents submission should be not less that five working days prior to the date that the provider intends to commence service delivery.

Outcome The period of certification will remain unchanged, but a new schedule may be issued in respect of corrective actions.

The Ministry will notify the DAA via letter of any additional requirements in terms of reporting on the next audit.

Note: A verification audit may be required where a provider is proposing a reconfiguration of services. The DAA will have received a copy of the requirement for audit that the Ministry sent to the provider. A verification audit can be undertaken at the time of surveillance prior to occupation and following any required structural work that has been completed.


4 Auditing Principles

The Ministry of Health requires auditors to follow the principles of ethical conduct, fair presentation, due professional care, independence and an evidence-based approach as outlined in AS/NZS ISO 19011:2003. In addition the following principles apply.

1. Consumer focus: care and services meet the needs and preferences of consumers consistent with current accepted practice.

Auditors shall use their technical and clinical expertise to collect audit evidence directly from consumers, relatives and providers and include a review of care received as an Episode of Care and in terms of individual service components.

2. Outcomes focus: the context for service provision must be considered, acknowledging that outcomes can be achieved through various inputs, activities and outputs.

Audit evidence shall reflect the inputs, activities and outputs that contribute to outcomes, giving due consideration to contractual requirements in the case of any Government-funded services that also rely on the HDSS as a means of measuring or monitoring standards of services and care.

3. Systems and process focus: effective systems and processes are implemented to support the delivering of services and care.

Auditors will determine through the collection of audit evidence that standards of service and care delivery are not dependent upon any one person, but rather upon the systems and processes present.

4. Openness and transparency: exchange of information is effectively communicated throughout the audit process.

Auditors ensure stakeholders are fully informed.



5 Designated Auditing Agency Responsibilities

Each DAA shall:

1. ensure the Ministry holds an up-to-date copy2 of their specific policies and procedures for auditing against NZS 8134

2. provide to the Ministry all reports and requirements generated by their third-party accreditation body, together with associated action plans that are a result of third-party accreditation activities

3. hold third-party accreditation3 with either JAS-ANZ4 or ISQua5 and meet all costs associated with this accreditation

4. ensure that an on-site surveillance audit is undertaken by the third-party accreditation body at the mid-point of the accreditation period or at more frequent intervals, as determined by the third-party accreditation body

5. appoint and utilise a committee for safeguarding impartiality, consistent with the requirements of ISO/IEC 17021:2006

6. employ or contract with competent auditors who have gained the New Zealand Qualifications Authority (NZQA) Unit Standard 80866 (demonstrate knowledge required for quality auditing) qualification (or equivalent as recognised by the Ministry) in auditing quality management systems (QMS) and have a demonstrated ability to comply with the requirements of AS/NZS ISO 19011:2003

7. ensure the audit team comprises competent auditors, auditors with clinical or technical expertise and consumer auditors, as appropriate to the service. Minimum requirements are outlined in Appendix 2 in section 13 of this handbook

Auditors may achieve demonstration of competence through successful completion of NZQA Unit Standard 80847 (audit quality management systems for compliance with quality standards) where this course is focused on competence assessment, involving assessment of workplace-based audits followed by written examinations containing questions relating to workplace-based audit records

8. ensure auditors employed or contracted by the DAA can demonstrate continual professional development through regular participation in audits and completion of at least eight hours per calendar year of professional development education and training relevant to their area of audit8

These can be submitted to the Ministry electronically. 2

shall be met in full before 31 December 2010. 3

5

ts against NZQA standards must be undertaken by an approved NZQA provider who ocus.

7

8 ssurance Act 2003 also need to meet the requirements of professional development to

Requirements of the third-party accrediting body

Joint Accreditation System of Australia and New4 Zealand.

International Society for Quality in Health Care. 6 Note assessmen

is acknowledged by the Ministry as being a suitable provider of auditor training that has a health f

See footnote 6.

Note that those health professionals who are auditors regulated through the Health Practitioners Competence A


Requirements for continual professional development should be consistent with ISO 19011.

Auditors with clinical expertise shall include within their professional development activities that ensure they are up-to-date with current QMS auditing and best practices for service delivery. Such professional development shall cover but is not limited to:

a. knowledge of all legislation and regulations relevant to the service setting (for example auditors undertaking residential care auditing require knowledge of enduring power of attorney in the context of personal care and welfare, and how this should be approached within a residential care setting)

b. knowledge of the current management of commonly occurring medical conditions relevant to the service setting (for example auditors undertaking residential care auditing require knowledge of congestive heart failure, chronic obstructive respiratory disease, diabetes, delirium, upper and lower respiratory tract infections and urinary tract infections)

c. knowledge of current nursing care management (for example auditors undertaking residential care auditing require knowledge of medication management, wound care, continence management, constipation, falls management, nutrition and hydration and pain management)

9. complete an annual performance review of all employed and contracted auditors which must at a minimum include a witnessed audit9 undertaken by the DAA of their staff and contractors

10. provide the Ministry with a current up-to-date auditor register (completed on a Ministry template) of those auditors and clinical/Technical Experts who undertake audits on behalf of the DAA

11. ensure auditors employed or contracted by the DAA comply with the code of conduct as outlined in Appendix 3 in section 14 of this handbook

12. provide to the Ministry, at least 15 working days prior to a scheduled audit, an audit plan and timetable for all audits where multi-site sampling, as agreed by HealthCERT, is included and for all DHB audits (note that multi-site sampling is not applicable to aged residential care services)

13. ensure all auditors complete a conflict-of-interest declaration prior to each and every audit

14. have established processes to specifically manage conflicts of interest at an organisational level – note that:

a. a DAA must not provide any consulting10 services to an organisation that is also a client receiving auditing services

addition to or part of this eight-hour

9 10

sion of specific advice, instruction or solutions towards the

maintain their annual practising certificates, which may be inrequirement.

Note this can be a surveillance audit or a certification audit.

‘Consulting services’ include, but are not limited to, design, implementation or maintaining of a qualityor management system (for example preparation of manuals or procedures; undertaking a gap analysis, conducting internal audits, provi


b. individual auditors must not provide auditing services where they have provided consultancy or educational services within the last two years to the same client

c. a DAA may arrange and participate as a lecturer in training courses provided that where these courses relate to quality assurance, management systems or auditing they shall provide only generic information and advice which is freely available in the public domain and includes a range of options or approaches the client could then act upon.11 A DAA must not provide specific advice to any client or provide a particular system for implementation for a client receiving auditing services from the DAA

d. providing internal ongoing professional development training to auditors employed or contracted by the DAA is a legitimate DAA activity and does not pose a conflict of interest

15. ensure all audit reports have been reviewed by the team leader/lead auditor and a peer reviewer prior to submission to the Ministry of Health. The peer review process shall include but is not limited to:

a. proofreading the report

b. ensuring the report is factual, accurate and free from repetition, and meets standards for reporting audit evidence (refer to section 8 of this handbook)

16. ensure there is rotation of auditors whereby the full audit team does not consist of the same members for the re-certification audit as it did for the prior certification or re-certification audit of any particular premise. A minimum of 50 percent of the audit team must not have been involved in the prior audit

17. comply with relevant legislation, including but not limited to:

a. the Health and Disability Commissioner Act 1994

b. the Health and Disability Services (Safety) Act 2001

c. the Health and Safety in Employment Act 1992 and amendments

d. the Health Practitioners Competence Assurance Act 2003

e. the New Zealand Public Health and Disability Act 2000

f. the Privacy Act 1993

g. the Health Information Privacy Code 1994

18. submit an annual self-declaration12 to the Ministry of Health, with all supporting documents available to the Ministry of Health on request

19. meet all requirements of designation as outlined in the Act, including publication of a Gazette notice (refer to Appendix 6 in section 17)

20. meet all time requirements for submission of information/reports as outlined in this handbook

development and implementation of a quality or management system; or participating in the decision-making system regarding such matters).

11 This requirement also applies to any separate organisation established by the DAA or their directors for the purposes of training or education.

12 Refer to Appendix 4 in section 15.

21. follow IAF MD2:2007 for the transfer of clients where the client has previously received services from another DAA

22. ensure clients of the DAA are aware that the Ministry of Health or a recognised third-party accrediting body (JAS-ANZ or ISQua) may accompany DAA auditors on any audit as part of their observation audit/witnessed audit, performance monitoring process or accreditation or designation/re-designation process

23. notify the Ministry of any client who has not satisfactorily completed an annual declaration, to enable the Ministry to determine whether an additional surveillance audit is required.


6 Audit Teams

Audit team requirements are outlined below.

1. The composition of the audit team must reflect the characteristics of the service and its users – for example, in terms of cultural background and service type.

2. Every audit team must include a person with clinical/technical expertise relevant to the service being audited, who holds a relevant annual practicing certificate (refer to Appendix 2 in section 13 for specific requirements) and an auditor with appropriate qualifications and experience as a lead auditor (team leader). Note: one person may be both the lead auditor and a clinical expert.

3. Clinical experts shall have recognised health qualifications and experience in the health field/services area to be audited.

4. Residential disability (intellectual, physical, psychiatric and sensory) care audit teams shall include a technical expert with qualifications and/or experience in the relevant area of service provision.

5. Residential disability (intellectual, physical, psychiatric and sensory) care audit teams shall also include a consumer auditor. Where a consumer auditor forms part of the audit team, the audit team shall also include a team leader/lead auditor (see consumer auditor specifications at section 0 and Appendix 2 in section 13).

6. Where additional technical expertise is required (for example, additional clinical specialists for specialised services) audits shall also include such technical experts.

6.1 Team leader (lead auditor)

The lead auditor (team leader) shall coordinate the audit. Including the points that follow but not limited to them, lead auditors or team leaders must:

1. confirm the membership of the audit team as appropriate to the type of audit being conducted

2. ensure conflict-of-interest declarations for each team member have been completed

3. ensure the audit is conducted in accordance with DAA policies and procedures and consistent with AS/NZS ISO 19011

4. for all announced audits, including those where multi-site sampling is included and for all DHB audits, ensure an audit plan has been developed prior to the audit and the client has received a copy. Note also the requirement to submit audit plans and timetables where multi-site sampling, as agreed by HealthCERT, is included and for all DHB audits

5. confirm audit arrangements with clients, as specified by AS/NZS ISO 19011, where an audit is announced



6. review prior audit information available to the DAA, including but not limited to:

a. document review

b. last certification audit

c. last surveillance audit

d. progress reports

7. contact the DHB if an audited client holds a contract to deliver health care services for that DHB. This contact will include but is not limited to:

a. notifying the DHB of the intended date of the audit

b. requesting the DHB provide the DAA with any relevant information that may contribute to the audit process

c. determining with the DHB the level of involvement it would like to have in the audit (for example witnessing the audit, receiving a copy of the report directly from the DAA, being involved in corrective action planning).

Note that an equivalent process should be followed where a service provider holds a contract with the Ministry’s Disability Services.

8. chair opening and closing meetings with the client, maintaining a record of these (refer to AS/NZS ISO 19011 for minimum requirements for opening and closing meetings)

9. ensure the service provider receives a copy of the audit findings at the time of the closing meeting, together with a clear outline of expected outcomes and the corrective action required

10. ensure the service provider has obtained consent13 from consumers for the audit team to undertake consumer interviews

11. liaise with the Ministry about the progress of the audit where a serious or critical risk has been identified

12. co-ordinate the audit team and be a resource to the team (refer to AS/NZS ISO 19011), for example in assisting to validate information collected

13. be the central point of contact for the client throughout the audit, liaising with them as appropriate to ensure openness and transparency throughout (refer to AS/NZS ISO 19011)

14. review the full audit report prior to the peer review of the report and submission to the Ministry

15. provide any auditor performance management feedback to the DAA.

13 Note that consent does not necessarily need to be written.

6.2 Audit team

The audit team should be comprised of auditors with clinical expertise, auditors with systems and organisational management expertise, consumer auditors and technical experts as necessary. Its role shall include but is not limited to:

1. working as a team and as a group of individuals who maintain good communication with the lead auditor (team leader) and with others as specified by AS/NZS ISO 19011

2. conducting the audit according to the principles and requirements set out in this handbook and AS/NZS ISO 19011

3. undertaking audit activities and tasks as assigned to them, as specified in AS/NZS ISO19011

4. working to timeframes, as specified in AS/NZS ISO 19011

5. supporting other auditors as necessary, as specified in AS/NZS ISO 19011

6. accurately reporting evidence and ensuring that documents are proofread prior to submission to the lead auditor (team leader)

7. providing feedback to the DAA as applicable.

6.3 Technical experts

A technical expert is a competent health professional with an annual practising certificate who has demonstrated knowledge, skills and experience in the service area being audited but does not necessarily hold an auditing qualification and does not act as an auditor within the audit team. For example, when auditing an alcohol and other drug (AOD) service, the DAA shall have available to them as a resource a technical expert who currently works or has recently worked for an AOD service providing clinical skills in the assessment, treatment and rehabilitation of clients requiring residential based services. The technical expert need not necessarily attend the audit in order to provide technical advice. Technical experts shall:

1. have demonstrated knowledge, skills and experience working within the service area being audited

2. be competent to make an informed opinion on the appropriateness of the services being offered in the service being audited

3. be able to identify trends in relation to service delivery

4. where the technical expert is not a qualified quality auditor and is not completing the Ministry audit reporting template, complete a report that forms part of the audit evidence

5. complete a conflict-of-interest declaration.



6.4 Consumer auditors

1. For all certification audits of residential disability (psychiatric, intellectual, physical or sensory) care, hospital care or residential mental health services (including alcohol and drug services), the audit team shall comprise a minimum of two members, being lead auditor/clinical expert and consumer auditor.14 Note that surveillance audits do not require a consumer auditor but will still require the audit team to include a lead auditor and clinical/technical expert.

2. Independent consumer auditors should contribute to the audit by way of their expertise and consumer experience in aspects of the HDSS (including the Privacy Code, informed consent and complaints mechanisms).

3. The consumer auditor shall be a full participant, visit each site and be fully involved in the audit (including audits for which HealthCERT has agreed to a sampling plan). A consumer auditor cannot be used as a technical expert on the same audit.

4. Principles for including an independent consumer perspective in an audit when auditing in accordance with the Act are set out below.

5. An independent consumer/kiritaki, when used, is expected to:

a. focus on the experience of people who use the services

b. be included in key meetings with the organisation, management, staff and consumers

c. facilitate meetings/interviews with service users and consumer groups

d. be engaged under the normal principles of employment, as they pertain to term of appointment, contract, remuneration, job description and adherence to codes of conduct such as those relating to confidentiality and non-disclosure protocols as they apply to all other team members

e. be trained in auditing principles, the use of the approved standards and audit tools as a member of the audit team

f. contribute to the audit of standards

g. be a participant in the total audit process, including reporting and any follow-up activities.

14 Note that this could be the same person if that person has the appropriate additional qualifications and

experience.


7 Audit Process Requirements

7.1 Unannounced audits

In the event that the manager of a service to be audited (or their deputy or other designated temporary manager) is not present on the day of audit and the auditors are unable to access all necessary information to complete the audit, the auditors will determine that criteria is partially attained unless either of the following instances apply, in which case the auditor will contact the manager the following day and obtain the information in order for the auditor to make a determination.

1. HDSS 1.1.13.3 – an up-to-date complaints register does not contain all complaints because the manager is holding a separate file on a current complaint under investigation due to confidentiality reasons.

2. HDSS 1.2.7.5 – records of ongoing education for staff are held in human resources files that are not accessible to staff working on the day of the audit.

In the event that the usual registered nurse responsible for a rest home is not available on the day of a spot audit, the auditor shall make contact with that nurse in order to obtain sufficient evidence prior to determining achievement of criteria relevant to the role of the registered nurse.

7.2 Two-stage audit process for certification audit

All certification audits will include a two-stage initial audit. The first stage audit will include off-site activities, including a document review15 of policies and procedures (covering, for example, management systems and clinical systems) and consideration of prior certification and relevant contractual audits (where supplied by a DHB) in order to allow the DAA to collect sufficient verifiable information to contribute to the second stage audit. A stage one audit may include additional activities, other than a document review consistent with ISO/IEC 17021. Where an audit is the initial certification audit, or first re-certification audit undertaken by a particular DAA, the DAA will provide to their client (the service provider) a findings report of the stage one audit results at least one week prior to the commencement of the stage two audit. The findings report content will include whether documents reviewed were present and displayed sufficient content to represent current accepted practice consistent with requirements of the HDSS. In the event that there are a large number of non-conformities identified in the stage one audit, the DAA will contact the Ministry to discuss appropriate timing for the next stage of the audit.

15 Note all the documents required for a document review may be provided by the premise to the DAA

electronically.

7.3 Audit duration

Audit on-site time shall be determined considering the following aspects (as applicable):

a. the fact that an auditor day is a minimum of eight hours

b. the size and complexity of the service being audited, including geographic spread between regional and outreach services from the primary service

c. results of prior audits

d. multi-site considerations

e. requirements to meet the standards of auditing practice required of the DAA

f. use of technical experts

g. the requirement that time on site should comprise at least 50 percent of the estimated total audit time.

The IAF MD5 for duration of QMS and environmental management system (EMS) audits will be used as a guide to determine the overall duration of audits. (Although note that requirements for audit duration as described in this section of the handbook take precedence over IAF MD5.)

7.4 Multiple sites

Multiple-site sampling can be undertaken where:

a. the multiple-site organisation being audited is under one governance structure

b. systems, processes, policies and procedures are applied consistently throughout the whole organisation

c. multiple services within the organisation have applied for certification under one certificate

d. the service is classified as a residential disability care service for people with an intellectual, physical, psychiatric or sensory disability.

Multi-site sampling requires prior agreement with HealthCERT. The DAA shall submit the proposed site sampling plan for approval that will include the number of premises that are required to have an on-site audit and those for which a site visit will be required. The site sampling plan is to be included within the audit plan. The Ministry requires the following information to be included in the multi-site sampling plan:

a. confirmation that the organisation operates under one governance structure with consistently applied systems, processes, policies and procedures

b. the total number of sites and their locations

c. the services provided within each site

d. the sites intended for an on-site audit

e. the sites intended for a site visit


f. the length of time intended to be spent by the audit team at each site visit

g. agreement of the provider to the proposed plan. A site visit must include at least the following:

a. a review of implementation of HDSS 1.2.3 (Quality and Risk Management)

b. a review of at least HDSS 1.3.12, and one other standard from the following: HDSS 1.3.3, 1.3.4, 1.3.5, 1.3.6 or 1.3.8

c. a review of any partially/unattained criteria identified during the on-site audit (ie, at other facilities/residences)

d. review progress towards addressing all required corrective actions from the last audit report.

In this situation the total number of audits shall be completed within 20 working days (or alternatively a period of time agreed in advance, and in writing, with the Ministry) of the first audit, and then submitted to HealthCERT within 20 working days of the last audit. Note that where multiple sites are included within one certificate, the period of certification specified by the Ministry will be based on the lowest level of achievement obtained by the provider for any one site.

7.5 Auditing against conditions on a certificate

7.5.1 Ministry inspection

Where a service has conditions added to their certificate as a result of a Ministry inspection, the Ministry generally requires the service provider to submit evidence directly to it as part of monitoring requirements. The DAA will be notified by the Ministry of any conditions added to a certificate applying to any of their clients, and the DAA shall audit against these conditions at the next conducted audit.

7.5.2 Requirements from previous non-conformities

When conducting an on-site audit, all conditions on the existing certificate shall be audited. Where a condition has been generated as a result of a corrective action, the DAA shall audit the HDSS criteria and not merely the completion of the corrective action. This also applies to any conditions that have been monitored by the DAA through progress reporting. For example, where three specific maintenance issues have been identified at a prior audit and a finding against HDSS NZS 8134.1.4.2.3 has been made, a re-audit will not determine whether these three specific issues have been addressed, but rather that the full requirements of HDSS NZS 8134.1.4.2.3 have been met across the service.



7.6 Evidence-based auditing

When conducting audits against the HDSS the DAA should consider all consumers’ experiences of services as an important part of the triangulation of evidence. Principles of sampling apply to the review of documents as well as interviews and observations.

7.6.1 Sample size

Designated auditing agencies shall ensure an adequate sample size for all audits as follows.

a. The minimum sample of clinical files and consumer interviews shall be the square root of the number of consumers (rounded to the highest whole number) for all certification and re-certification audits and 0.6 times the square root of the number of consumers for surveillance audits. Alternatively, where there are less than 10 consumers in a service, a minimum of five consumers should be interviewed and their corresponding clinical files reviewed.

b. At least 10 percent of sampled clinical files should review a consumer’s care experience using tracer methodology.

c. In determining the minimum number of medication records to be reviewed as part of the audit, DAAs should apply the square root rule and double the result.

d. If the service is spread over a number of sites, or includes a number of specialties/ sub-specialties, DAAs shall sample in such a manner that it includes each site, specialty or sub-specialty. The sample shall represent a minimum of 10 percent of data available in each group.

e. Personnel (staff, management, contractors, visiting health professionals and advocates) shall be interviewed as part of the audit process, as follows.

i. In determining the minimum number of staff to be interviewed in addition to management, consumers and visiting health professionals, the square root rule can be applied.

ii. The sample shall represent all shifts and roles of staff, which may mean a greater number than that represented by the square root applies. (Note that this requirement may be achieved by interviewing staff working on a day or afternoon shift who also work night shifts as part of rotating duties or relief duties.)

iii. The DAA shall, where possible, interview at least one general practitioner (GP) providing services to the consumers of the audited services16 in all audited residential care services.17

iv. In the case of disability services, the DAA may interview the Needs Assessment Co-ordination Service (NACS).

v. Where possible the DAA shall interview at least one medical clinician from each service in all audited hospital services.

16 A telephone interview is acceptable should the GP not be at the facility on the day(s) of the audit.

Note that if the GP declines to be interviewed this must be recorded in the audit report and shall not affect the level of attainment awarded for any criteria.

17 Certification and surveillance audits.

vi. The DAA shall ask any visiting advocates present on the day of audit (for example Age Concern, Grey Power or Health and Disability Commissioner (HDC) advocates) whether they wish to be interviewed. Where there is a regular consumer advocate associated with a service, the DAA will formally ask this person whether they wish to be interviewed (either on-site or via a telephone interview prior to the audit).

f. Where the DAA finds non-compliance, sample sizes should be widened in order to verify whether the case is one of system or process failure, or a one-off anomaly.

Auditors shall not allow the service to pre-select samples for them. This applies to staff, consumers and clinical files. Auditors shall interview every consumer, staff member or relative who specifically requests to be interviewed.

7.6.2 Stratified sampling

Auditors shall identify relevant sub-groups as part of their sampling methodology in order to consider the different characteristics of the population catered for by the service being audited. Examples of relevant sub-groups for aged residential care services include consumers:

a. with impaired cognitive function

b. receiving wound care

c. receiving palliative or terminal care

d. with behavioural symptoms. Examples of staff sub-groups may include:

a. registered nursing staff

b. health care assistants

c. administrative staff

d. full-time staff

e. part-time or casual staff

f. staff who work night shifts

g. direct staff

h. supervisory staff.

7.6.3 Random sampling

Random selection of consumers, staff or documents (where any individual or document is as likely to be chosen as the next) reduces the likelihood of bias and allows for accurate generalisation of audit results. In every audit, DAAs shall randomly select a number of clinical files through random sampling in addition to stratified sampling. On-site, auditors are expected to choose consumers and staff for interview as randomly as possible.


7.6.4 Incidental sampling

Incidental sampling occurs where an auditor selects the sample based on collection of evidence from whomever or whatever comes along (for example informal talks with consumers on a tour of the facility). Auditors shall not use incidental sampling as the principal form of evidence collection, although the use of incidental sampling can supplement other information collected throughout the audit process.

7.6.5 Tracer methodology

A minimum of 10 percent (rounded to the highest whole number) of the sample size shall include a review of consumers’ care experiences, using tracer methodology, to allow demonstration of the way an audited service implements certain systems and processes. Tracer methodology requires an auditor to review assessment, care and service provision, and allows an audit of the continuum of care matched to a consumer’s experience of service provision. Two examples follow.

a. If a consumer in a residential service has recently experienced a chest infection, the audit would include review of the assessment undertaken when the consumer became unwell, medical care prescribed and delivered, short-term care planning and documentation of the delivery of care in progress records and on observation charts, along with a record of the care experience as recounted by the consumer and/or their relatives and staff.

b. An audit tracing a consumer requiring wound care would include review of the wound assessment process, care plan, progress of wound healing, liaison between health professionals (for example wound care nurse and doctor) and management of the consumer’s diet, and an interview of the consumer.

Suitable samples for review of a consumer’s care experience include but are not limited to:

a. a consumer who has been involved in an incident or accident

b. a consumer who has experienced a recent illness

c. a consumer in a residential service requiring public hospital admission following a change in their condition

d. a consumer receiving palliative care.

7.6.6 Example

Below is an example of minimum sampling requirements.



Service Number of beds (from a total of 110)

Sample of records (using the square root rule and complying with additional sampling requirements = 11)

Sample of consumers (matching to the sample of records and extending to meet the square root rule if some consumers cannot or do not wish to participate in an interview)

Sample of staff (using the square root rule while ensuring a representative sample across all shifts and roles) – if the service employs 40 staff auditors shall interview a minimum of seven, plus management

Rest home 50 beds, including 18 dementia beds

Two files pertaining to dementia beds – both for consumers with behavioural symptoms

Two files pertaining to rest home beds – both for consumers who have experienced an increased numbers of falls and associated incidents

Observation of two dementia consumers, and interviews with two relatives of dementia consumers

Interviews with two rest home consumers

Two staff interviewed (one from the dementia unit and one from the rest home), one of whom could be a part-time worker, from each of the morning shift, the afternoon shift and the night shift’

Hospital 60 beds Seven files: two chosen using Tracer Methodology (one consumer with a wound that is not healing and another who has had a recent public hospital admission) and the remainder chosen randomly

Five hospital consumers

Two relatives

Two staff interviewed (one registered nurse and one health care assistant), one of whom could be a part-time worker, from each of the morning shift, the afternoon shift and the night shift’

Medication records

110 records 22 records (same files as file reviews plus additional via random sample)

Total service Manager and clinical manager

Administrator

GP (who sees the majority of people)

Age Concern advocate (who regularly visits the service)

Cook

Activities officer

7.7 Interviewing

Auditors shall use interviews to:

a. gather new audit evidence

b. corroborate audit evidence. Interviewing of staff,18 consumers and relatives should not solely take place in groups: in such a situation an individual may not disclose his or her true opinions, due to the lack of confidentiality.

18 Note, however, that staff may be interviewed in pairs or with a support person. Where staff are

interviewed together they should be of the same level (for example, both caregivers or both registered nurses, neither at the managerial level).


Auditors shall apply sampling methodology to interviewing as described in the section above. Note that the sample size shall be sufficient to ensure conclusions are representative of the service being audited. Interviewing shall be used to corroborate information such as how processes work and their effectiveness. When interviewing the DAA shall ensure auditors:

a. obtain permission from interviewee(s)prior to conducting the interview

b. conduct interviews in an appropriate environment that provides for adequate privacy

c. reduce barriers to effective communication (for example, do not use jargon, take into account hearing impairments or specific cultural requirements)

d. introduce themselves to the interviewee(s) before beginning the interview

e. explain the purpose of the interview to the interviewee

f. explain that the interview is confidential and that what the interviewee says will not be referenced in a way that could identify them

g. seek permission to take notes

h. commence the interview using a standard set of questions19

i. use a balance of open and closed questions

j. validate their understanding by summarising or reflecting information back to the interviewee

k. end the interview by allowing the interviewee to ask any questions or make comments that may not have been covered within the interview.

7.7.1 Relatives

Certification and re-certification audits shall gather information from a sample of relatives, either through an interview or a survey conducted by the DAA. The DAA shall ensure:

a. relatives are interviewed individually or as a family, either in person or in a telephone interview

b. focus group interviewing represents no more than 10 percent of the sample of consumers and relatives

c. where a DAA undertakes a survey of relatives, the survey is posted to all relatives at least two weeks prior to a certification or re-certification audit, along with a pre-paid envelope for the return of the survey.

Unannounced surveillance audits shall include incidental sampling of relatives. This means that DAAs shall ask relatives visiting the service on the day or days of the surveillance audits if they are happy to be interviewed as part of the audit process. Note that if a sufficient sample has been obtained, not all relatives need be asked.

19 The DAA is responsible for the development of questions unless otherwise notified by the Ministry.

7.8 Collection of audit evidence

AS/NZS ISO 19011:2003 defines audit evidence as ‘records, statements of fact or other information which are relevant to the audit criteria and verifiable’. Auditors shall collect evidence using appropriate sampling methods, including but not limited to interviews, documentation and observations. Auditors shall consider the sufficiency and relevance of the information gathered prior to making audit findings. They shall not use one-off events and unsubstantiated information as the sole basis for an audit finding, but should use such data as a prompt to collect more information in order to corroborate or repudiate the initial information. Where an auditor determines that an isolated event posed a serious risk of harm or potential harm to a consumer, they are required to return later to determine that the service in question has remedied the situation and the risk of reoccurrence is negligible, or to further substantiate the risk and make an appropriate audit finding and agree on an action plan. The auditor should determine whether the Ministry should also be specifically notified of this event. Auditors are required to corroborate each piece of evidence they cite, to increase the reliability of their findings. The corroboration process should include substantiation from at least two sources. Auditors shall strive to triangulate evidence as part of the corroboration process. Triangulation requires evidence to be gathered from three sources, by the use of three different strategies. This may include a combination of the following:

1. Interview of consumers, relatives, personnel (managers, staff members), other health professionals (for example, a GP, a clinical specialist, an allied health professional, NACS) and advocates (for example, Age Concern, Grey Power, HDC).

2. Review of documents, including but not limited to:

a. plans, policies, procedures, manuals and work instructions (for example, a service’s quality and risk management plan, annual plan, clinical policies and procedures, cleaning procedures or infection control manual)

b. information for consumers and other stakeholders (for example, pamphlets or admission brochures)

c. clinical records (for example, nursing, medical, allied health, medicines, wound care, completed assessments, progress, complaints, incident and accident records)

d. other records (for example, personnel records, staff training records or minutes of meetings)

e. reports (for example, quality assurance or self-assessment reports)

f. forms (for example, data collection forms used as assessment tools)


3. Observation of process. Observation allows the auditor to review practices in the service on the day of audit, including (but not limited to) assessing elements of the living environment and physical environment; reviewing practices such as activity programmes and the presentation, sufficiency and appropriateness of meals; and identifying any support required by consumers.

The sole exception to the requirement for more than one source of evidence is an auditor’s sighting the building warrant of fitness and current operative evacuation scheme approved by the New Zealand Fire Service. Auditors shall code evidence source as specified in the ‘Evaluation Methods’ requirements of HDSS NZS 8134.0:2008 (General Standard).

7.8.1 Mental health services

When auditing mental health services against HDSS NZS 8134:1.3.5.4, note that in the case of people who have been consumers of mental health services for two years or more, the Ministry focuses on relapse prevention planning through DHB accountability processes , and as such requires DAAs to pay particular attention to relapse prevention planning in their audits. A relapse prevention plan is defined by the Ministry as follows:

Relapse prevention plans identify early relapse warning signs of clients. The plan identifies what the client can do for themselves and what the service will do to support the client. Ideally, each plan will be developed with involvement of clinicians, clients and their significant others. The plan represents an agreement and ownership between parties. Each plan will have varying degrees of complexity depending on the individual. Each client will know of (and ideally have a copy of) their plan.

7.9 Analysis of audit evidence

Auditors shall discuss findings with the whole audit team and analyse them in order to reach conclusions. When undertaking an analysis of evidence, the audit team shall determine:

a. whether evidence supports the achievement of criteria (sufficiency)

b. whether evidence has identified deficiencies in systems, policies or processes

c. whether evidence has identified deficiencies in the implementation of systems and processes

d. trends within evidence

e. causes of identified deficiencies, to assist providers to develop and agree on a corrective action plan

f. risks and consequences of issues identified (using the HDSS risk matrix).



The analysis shall result in findings with clear rationales that rate results against each criterion and contribute to the determination as to whether a standard has been met or not met, with linkages between individual pieces of information showing clear relationships and causalities. Conclusions shall be fair, balanced and free of bias.

7.9.1 Ratings

The audit report shall reflect findings and ratings at the time of the audit. This will ensure that appropriate criteria will be further monitored at subsequent audits. Levels of attainment at criterion and standard level are defined in HDSS NZS 8134:2008 under ‘Audit Framework’. Auditors shall ensure that:

a. they record in the report an explanation of the reason for any criterion being ‘not applicable’ to the service being audited

b. they document audit evidence for each criterion and standard in a way that meets the reporting requirements set out in this handbook

c. any criterion that contains a corrective action planned for a future date is not to be rated as ‘fully attained’ (FA). If completion of a corrective action is advised to the DAA prior to the completion of the audit or submission of the report, the grading remains ‘partially attained’ (PA) or ‘unattained’ (UA), and the risk rating shall remain as it was determined at the time of the on-site audit. The report may reflect that action has been taken, and the impact of this action on the risk level may be contained in the report commentary

d. where a ‘continuous improvement’ (CI) rating is awarded, audit evidence shall demonstrate:

i. achievement beyond the expected full attainment

ii. linkages to the overall quality system. That is, it is part of an overall quality management system that focuses on systematic and integrated improvements through initiatives that have clearly defined objectives and an associated work plan

iii. systematic and sustainable outcomes

Note: When conducting an audit, to determine whether continuous improvements are being made within a service the following elements should be considered:

i. planned improvements made over the last 12 months where the benefits of these improvements have been evaluated

ii. improvements planned for the following 12 months including why they are necessary and how this has been determined, how the changes will be introduced and how the effectiveness will be monitored and evaluated.20

20 Note a CI cannot be awarded for planned future actions of the provider.

Key considerations that need to be answered in order to determine the effectiveness of continuous improvement planning include:

i. how various initiatives link to the quality management system

ii. whether process improvements are developed using input from a range of stakeholders including staff and consumers

iii. the mechanism to determine what initiatives are required

iv. the role of management in leading and supporting initiatives

v. the level of benefit consumers will derive from the initiatives

vi. the level of staff support for initiatives

vii. whether the expected results are realistic and achievable according to the plan developed

viii. whether initiatives are aimed at fixing problems rather than a systematic review of process and performance that identifies opportunities for improvement

e. where multiple service categories are being audited for a single service provider or where multiple wards or service areas provide the same service, ratings awarded for each criterion shall reflect the lowest level of attainment achieved. For example:

i. one medical ward achieves a PA for the same criterion for which another medical ward at the same provider achieves a FA: the rating awarded for this criterion shall be a PA

ii. a rest home service achieves a PA for the same criterion for which the hospital service at the same provider achieves a FA: the rating awarded for this criterion shall be a PA.

Only the following HDSS attainment ratings may be changed within the period between the end of the On-site Audit and the submission of the report:

a. NZS 8134.0:2008 1.4.2.2 – Building Warrant of Fitness or Code of Compliance

b. NZS 8134.0:2008 1.4.7.3 – New Zealand Fire Service approval of an evacuation scheme, or written approval of an exemption.

7.9.2 Corrective action

Audit teams shall generate a corrective action request for each audit finding resulting in a PA or UA rating. Audit conclusions resulting in corrective action requests shall:

a. clearly define the extent of the issue (description, level of attainment and risk rating)

b. provide a rationale for the finding

c. describe expected outcomes


d. describe actions to be taken that have been developed by the service provider and approved by the DAA (or alternatively, developed by the DAA and agreed by the service provider) in a corrective action plan

e. define timeframes for these actions

f. define the method and frequency of reporting to be made against progress. Corrective actions may form part of, or be related to, a condition of certification. Corrective action planning shall be undertaken in consultation with a DHB portfolio manager or Ministry’s Disability Services, if required actions directly influence a service contract held with a DHB or the Ministry. The DHB portfolio manager or Ministry’s Disability Services staff shall agree with the DAA on the mechanism for ongoing monitoring of requirements, which shall be clearly stated in the audit report to the Ministry. The service provider is responsible for developing the action plan and implementing the corrective actions, and the DAA is responsible for reporting on the service provider’s progress. This may occur through progress reporting and/or on-site auditing (refer to information on progress reporting in section 12 of this handbook).


8 Audit Reporting

The purpose of a DAA undertaking an audit is to provide the Director-General of Health (the Director-General) with an audit report to allow the Director-General to determine if the provider meets the required standards. Audit reports submitted to the Ministry shall use the Ministry audit reporting template and present evidence that is competent, sufficient, relevant and reliable. In order for evidence to be:

a. competent it shall:

i. be collected by appropriate skilled and experienced members of the audit team (that is, technical experts, qualified lead auditors and auditors with clinical expertise matched to the service being audited, as appropriate)

ii. be derived from an adequate sampling methodology (see section 7.6.1 of this handbook)

iii. demonstrate corroboration of evidence, triangulated wherever possible, from a variety of reliable sources

iv. include evidence from documented records and interviews with stakeholders that can be substantiated

b. sufficient it shall:

i. describe practice (implementation) and provide documentation and interviews which support findings

ii. provide detailed information with relevant and quantified examples

c. relevant it shall:

i. demonstrate the relationship between actual and expected outcomes

ii. be consistent

d. reliable it shall:

i. report attainment ratings against each criterion and standard

ii. report risk ratings against each criterion and standard

iii. be proofread and endorsed by the lead auditor prior to submission to the Ministry.

8.1 Documented evidence

The following minimum standards are required when documenting evidence.

a. Evidence is reported against attainment ratings (as specified by HDSS NZS 8134:2008).

b. Evidence is reported against risk ratings (as specified by HDSS NZS 8134:2008).

c. Evidence is quantified (that is X of X statements that specify the number of variables).


d. Evidence sources are referenced and do not include any self-assessments undertaken by the service in preparation for the audit. (Auditors shall provide independent evidence of attainment and methods of validation for each criterion.)

e. Evidence clearly distinguishes differing service categories and service areas (for example dementia unit within a rest home or acute medical unit within a medical service) where evidence has been collected.

f. Evidence is written in the present tense and does not include statements of intent.

g. The team leader/lead auditor reviews reports, and they are peer reviewed prior to submission to the Ministry.

8.2 Reporting of critical and high risks

The team leader/lead auditor or DAA shall report to HealthCERT in writing within 24 hours of the time of the audit any services where the level of risk is assessed as critical, according to the HDSS risk matrix. The team leader/lead auditor or DAA shall report to HealthCERT in writing within 24 hours of the time of audit any services where the level of risk is assessed as high across multiple criteria, posing an increased level of risk that the Ministry should immediately be aware of. Where a service holds a service contract with a DHB and a DAA identifies critical or high risk issues, the DAA shall ensure the DHB is aware of the proposed action plans to address risks to safety.

8.3 Submission of the Ministry of Health audit report

Every audit report shall be submitted electronically to HealthCERT within the Ministry of Health and, in the case of service providers who hold contracts with a DHB, copied to the relevant DHB (unless the DHB states otherwise). Prior to the submission of the Ministry audit report, the DAA shall ensure that:

a. the service provider has had an opportunity to comment on the draft report

b. every mandatory field has been completed (including the executive summary and audit summary for publication)

c. finding statements and corrective action requests are completed and appropriate to the level of attainment and risk determined

d. the report has been reviewed by the team leader/lead auditor and a peer reviewer, and is complete

e. the report has been received by the service audited.

8.3.1 Timeframes

Audit reports are to be submitted within 20 working days of the last site visit undertaken in the case of provisional, certification and re-certification audits.


Audit reports are to be submitted within 15 working days of the last site visit undertaken in the case of surveillance audits. In the case of multi-site providers, the total number of audits shall be completed within 20 working days (or such other time agreed with the Ministry in advance, and in writing) of the first audit, and the report submitted to HealthCERT within either 15 (in the case of surveillance audits) or 20 (in the case of all other audits) working days, as stated above.

8.3.2 Supporting documents

If the audit template is inadequate or incomplete and Ministry advisors need to seek further clarification, HealthCERT will ask for submission of the required evidence. Within two working days this shall be either:

a. sent to HealthCERT, Ministry of Health, PO Box 5013, Wellington

b. emailed to: [email protected]

c. delivered to HealthCERT, Ministry of Health, Level 2, 1 The Terrace, Wellington. Additional evidence that may be required includes but is not limited to:

a. document reviews

b. audit plans

c. conflict-of-interest declarations for each member of the audit team

d. opening and closing meeting records

e. audit tools, checklists or work books

f. interview records

g. auditor notes

h. reports written by technical experts.

8.4 Incomplete or inadequate reports

If audit reports present conflicting, incomplete or insufficient supporting evidence, the chief executive officer of the DAA will be notified and the report returned to the DAA for completion and re-submission. Where the Ministry has to repeatedly request additional evidence or clarification, or that reports are to be resubmitted, and the DAA has been provided with ample opportunities to rectify the issues but has failed to, the Ministry will treat this as a performance issue and notify the appropriate third-party accrediting body. The Ministry may choose to terminate designation of the DAA.


mailto:[email protected]

9 Audit Summary for Publication

Informative summaries of certification audits, further surveillance or provisional audits, or audits for additions to services are published on the Ministry website. This only applies to aged residential care facilities requiring certification under the Act. An informative summary of audit findings should enable consumers and their families to make more informed choices regarding care options and also provide the wider public with additional information to assist in their risk analysis of a facility based on exception reports. The Ministry will also publish on the website a summary of information on certified providers, including name, location, ownership, number of beds, DAA and period of current certification. Where necessary, an addendum will acknowledge whether the period of certification has been materially affected by additional information held by the Ministry (see section 10 of this handbook). The Ministry has a responsibility to check the accuracy of the summaries in relation to full audit reports, and will acknowledge the source of the summary information as the DAA. All summaries submitted by DAAs to the Ministry shall be developed in consultation with the provider and are contained within the executive summary section of the audit reporting template. The DAA shall clearly document any disagreement on the content of the summary between the DAA and provider. The following information can be published as an addendum to the certification audit information:

a. a summary of any audit or inspection conducted by either a DHB (or their representative agency) or the Ministry that has resulted in audit findings substantiating a received complaint about the health service provider

b. a website link to any HDC report naming a health service provider as being in breach of the HDC Code of Rights

c. summaries as provided by a DAA, developed in consultation with the provider, that update the level of compliance against a finding from the certification audit on the request of the service provider and where the DAA can evidence implementation of compliance requirements through an on-site audit.

An addendum will be published in chronological order to ensure the most recent information is readily retrievable. Addendum information will remain published (that is, will remain online) for the current period of a service provider’s certification.


9.1 Exception process

If the Ministry determines the DAA report has not provided a factual summary of the audit, the Ministry will seek further clarification from the DAA and if necessary:

i. request that the DAA provide additional audit evidence to the Ministry, update the electronic report with the additional evidence and re-send it to the Ministry within two working days; or

ii. request that the DAA consult with the provider and re-submit a revised summary within 10 working days.

If requested, the DAA shall provide a new summary in writing and include acknowledgement that the provider has been consulted and is in agreement with the new summary. Alternatively, the DAA shall advise the Ministry that the provider has been consulted in the development of the new summary but is not in agreement with it, to the extent that they would not wish to have it published. If the provider does not wish to have the new summary published the Ministry will contact the provider directly and discuss their specific concerns. If a satisfactory result cannot be reached between the DAA, the provider and the Ministry and the Ministry considers the new summary to be a factual reflection of the audit, the Ministry will give 15 working days’ notice of their intention to publish the new summary. The provider can, in this time, request to have the wording amended or take other action (for example an injunction) to prevent the Ministry from publishing the new summary. In the event the provider has taken action to prevent the publication of the summary, the Ministry will publish a statement to the effect that the provider had requested a summary not be published.


10 Publication of Addendums

An addendum is an addition to the certification summary that is published on the Ministry’s website. An addendum can include:

a, a statement of improvement provided by a DAA that has been developed in consultation with the provider following verified attainment of a previously partially or unattained standard/criterion

b. a statement issued by the Ministry in relation to a substantiated complaint or issue investigated by the Ministry or their representative.

Where a DAA has verified attainment of a previously partially or unattained standard/criterion and the provider requests that an addendum be published, the DAA shall prepare an addendum statement (written in plain English) in consultation with the provider. In this case the DAA shall complete a progress report form and forward this to the Ministry, together with supporting evidence of attainment. The Ministry then publishes the addendum.


11 Progress Reporting

Written progress reports apply to any certified provider whose schedule contains a condition that requires a DAA to submit a progress report to the Director-General of Health after 1 October 2009, and to any certified provider whose schedule states:

A written progress report that outlines all actions undertaken by the provider in relation to corrective measures against Health and Disability Services Standards [insert relevant standards] (as approved under section 13 of the Act) must be submitted to the appropriate designated auditing agency by [insert relevant date]. The designated auditing agency will notify the Director-General of Health of progress, if any, if required in accordance with the Ministry of Health’s requirements for the processing of progress reports.

This policy does not apply to providers whose schedule includes a condition where the provider is:

Required to provide a written progress report directly to the Ministry of Health or the Director-General of Health.

11.1 Procedure

Where a condition on a certified provider’s schedule requires “a written progress report to be submitted to the Director-General of Health by a Designated Auditing Agency” and the condition has a submission date subsequent to 1 October 2009, responsibility for monitoring the provider’s progress lies with the DAA. The DAA shall ensure receipt of the written progress report from the provider by the date specified on the provider’s schedule. It shall then assess the progress report to determine if any non-conformity has been corrected since the last audit. Where conformity is considered fully attained, the DAA notifies the provider of its acceptance of the report. Where a PA/UA rating continues with low risk, the DAA manages the non-conformity with the provider and shall continue to monitor progress against the requirement generated at the time of the audit. There is no requirement to notify the Ministry. However, audit records shall be maintained, and are subject to review as part of an accreditation body’s assessments. The DAA is required to report to the Ministry on:

a. a service provider’s progress against criteria audited as high risk at the last certification/surveillance audit (noting whether particular issues have now been rectified or whether progress is being made but the criteria remains partially attained)

b. a service provider’s progress against HDSS1.2.8.1 (service provider levels and skill mixes) irrespective of the risk level as it appears in the audit report

c. areas in which inadequate progress is being made by a service provider, irrespective of the risk rating as it appears in the audit report.


The report shall be presented on a completed progress report standard form submitted to HealthCERT (see Appendix 5 in section 16). Where the Ministry becomes aware of a particular issue with a provider (for example a consumer complaint or DHB or HDC Office concerns) and the issue relates to criteria identified within a scheduled progress report, the DAA may be contacted to provide information.


Appendix 1: Example Provider Declaration for DAA Use

Annual service provider declaration

Introduction

In any year where a service provider has not undergone an on-site audit by a DAA, a self-audit is required against a subset of the HDSS as a means of confirming to the DAA that the provider is undertaking sufficient ongoing internal monitoring of conformity, and to monitor any changes to the service. It is the responsibility of the DAA to ensure service providers submit declarations resulting from self-audits in a timely fashion at no less than yearly intervals. Where a service provider does not conduct an internal audit or provide a satisfactory declaration the DAA shall advise the Ministry, which may then request an additional on-site surveillance audit. The DAA shall review all declarations and retain these as a record contributing to the monitoring activities that occur in between on-site surveillance audits.

Self-audit record

The service provider shall conduct an internal audit with sufficient scope and depth to verify their conformity prior to completing the information required in this form. Providers shall make internal audit records available for review by the DAA.

1. Describe all changes to key personnel (governance, organisational management, clinical management down to team leader level) that have occurred over the last year.

a. Provide the names, qualifications and experience of key personnel employed over the last year.

2. Describe if staffing has been sufficiently consistent with your staff skill mix policy, DHB contractual obligations and the acuity of consumers within the service.

a. If there have been any staffing shortfalls, describe how these have been managed.


3. Confirm whether the internal audit system is fully implemented, and consistent with the quality management system policy and schedule for internal audits. Detail key actions taken in response to internal audit findings.

a. If implementation is behind schedule, outline the action plan that will be put in place to remedy this.

b. If key actions have not been developed or implemented in response to internal audit findings, outline activities now planned to ensure this occurs.

4. Summarise any complaints received since the last DAA audit, including actions taken and whether each complaint has been resolved or remains active.

a. Include any external agency involvement (for example, advocacy services, HDC, DHB, the Ministry).

b. Detail whether any complaints have led to service changes.

5. Summarise any incidents or accidents that have occurred resulting in an injury to a consumer, visitor or staff member.

a. Confirm whether trend analysis of incidents and accidents has been undertaken.

b. Detail any service changes that have occurred in response to individual events or the analysis of trends.

6. Detail any medication errors that have occurred and actions taken to avoid similar errors occurring in the future.


7. Confirm that the system has identified all staff members who are authorised to administer medicines and that all of these staff members have been verified as competent to do so and there are documented records verifying their competency.

8. Confirm that infection control surveillance is being undertaken consistent with the infection control programme.

a. Detail any actions taken as a result of trend analysis or outbreak.

9. Confirm that there is ongoing monitoring of the use of enablers and/or restraints.

10. Name any operational (management and clinical) policies or procedures that have been added to or changed in your document management system in the last year.

a. For each policy or procedure that has been added or changed, confirm that staff have received notification of the changes and appropriate training.

11. Outline any legislative compliance issues (for example health and safety, employment, local body) affecting this service.

a. For each issue identified, summarise actions taken to remedy and whether there are outstanding issues that are unresolved.

12. Confirm that your service has a current annual quality plan and will be developing one for the upcoming year.


13. Outline any activities planned for the coming year that will contribute to continuous quality improvement.

14. Outline any other changes that have occurred within the service which may be relevant to meeting the requirements of the Health and Disability Services Standards.

Declaration

The information provided in the internal audit record is current, accurate and verifiable, and the person who completed the internal audit for the purposes of this declaration was competent to do so. The person making this declaration has the delegated authority of the organisation to do so. Name................................................................................................................................. Position.............................................................................................................................. Service name..................................................................................................................... Contact details...................................................................................................................

.......................................................................................................................................... Date...................................................................................................................................


Appendix 2: Auditor Competency Requirements Specific to Service Categories

The following table outlines minimum audit team requirements by service categories. Note that all audits require a qualified team leader/lead auditor as part of the audit team. Service category

Particular members of audit team required

Responsibility for audit of HDSS – NZS 8134.1:2008

Responsibility for audit of infection prevention and

control standards – NZS 8134.3:2008

Responsibility for audit of restraint minimisation and

safe practice standards – NZS

8134.2:2008

Hospital care Qualified team leader/lead auditor

Qualified quality auditors

Technical experts depending on nature of service, as indicated below

Children’s health services

A currently practicing paediatric nurse or other appropriate registered nurse (RN) who holds an annual practising certificate (APC) with a background in child health

Parts 1, 2, 4 – audit team member, with oversight as necessary from technical expert for 1.8

Part 3 – technical expert

Technical/ clinical expert (or team leader/lead auditor)

Team leader/lead auditor, with oversight as necessary from technical expert

Medical services

A currently practising medical nurse or other appropriate clinician/RN with a current APC, depending on the size and complexity of the service

Additional specialised technical experts as appropriate, depending on the nature of the hospital setting

As above As above As above

Surgical services

A currently practising surgical nurse or other appropriate clinician/RN with a current APC (for example, subspecialty nurse), depending on the size and complexity of the service

A medical clinician with surgical experience acting in the capacity of technical expert


Maternity services

A currently practising midwife (with current APC)




Service category







8134.2:2008

Mental health services

A currently practising psychiatric nurse (or other RN with a mental health background as a component of their scope of practice and a current APC)

A mental health consumer

More specialised clinicians as appropriate, depending on the nature of the hospital setting (for example a psychiatrist or an alcohol and other drug clinician)

As above, with the assistance of a mental health consumer

As above As above, with the assistance of a mental health consumer

Geriatric services

A RN (with a current APC) experienced in the provision of auditing of aged care services, medical services or assessment, treatment and rehabilitation services

More specialised clinicians as appropriate, depending on the nature of the hospital setting (for example a geriatrician or a GP)

Parts 1, 2, 4 – team leader/lead auditor, with oversight as necessary from technical expert for 1.8


As above Team leader/lead auditor, with oversight as necessary from a technical expert

Large multi-service hospitals (for example, a DHB)

An appropriate mix of clinical backgrounds, depending on the extent of specialised hospital services

A person experienced in hospital management or with experience auditing large hospitals, either leading the team or as a team member

Note: an audit plan with the names of the audit team (including technical experts) shall be submitted to the Ministry prior to conducting any audit

Parts 1–4 to be allocated among the audit team in accordance with areas of expertise and audit process responsibilities

As above Relevant expertise for the size and skills of the audit team

Rest home care

A RN with a current APC experienced in the provision or auditing of aged care services (with a background in aged residential care nursing, medical nursing or assessment, treatment and rehabilitation services)

Where dementia services form part of the service, a technical expert or auditor with experience in dementia care or auditing of dementia care

Parts 1, 2, 4 – team leader/lead auditor)


As above Team leader/lead auditor


Service category







8134.2:2008

Residential disability care (intellectual, physical or sensory) and psychiatric care (including alcohol and drug services)

An appropriate consumer auditor (certification/re-certification audits)

A team leader/lead auditor with qualifications or experience in the delivery or auditing of this type of service, who may have a nursing, allied health or rehabilitation qualification, or relevant background in the field and knowledge of the philosophy underpinning the sector

Note: a technical expert may additionally be part of the audit team where the team leader/lead auditor does not meet the service specific qualifications or experience as above

Parts 1, 2, 4 – team leader/lead auditor)

Part 1 (Part) – consumer representative


Team leader/lead auditor, with the assistance of consumer representative

Team leader/lead auditor, with the assistance of consumer representative

Appendix 3: Code of Conduct for DAA Auditors

Under the code, an auditor is required:

1. to act professionally and accurately, and to report findings in a consistent and unbiased manner and in accordance with Ministry requirements

2. to undertake audits only in accordance with Ministry requirements, procedures and guidelines, and with AS/NZS ISO 19011:2003

3. to strive to increase the competence and prestige of auditors by continuing to develop their auditing skills

4. not to misrepresent his/her own or any other individual’s qualifications, competence or experience, nor undertake auditing work beyond the scope of his/her qualifications

5. to disclose to the DAA any current or prior working or personal relationships that may be seen as a conflict of interest or that may influence his/her judgment

6. not to enter into any activity that may be in conflict with the best interests of the Ministry or the DAA, or that would prevent the performance of his/her duties in an objective manner

7. to adhere to the requirement of the Act, the Privacy Act 1993 and the HDC Code of Consumers’ Rights and all other relevant legislation, regulations, guidelines, codes and best practice standards

8. not to promote or represent any business interests or any entity with which he/she has an interest or may have an interest while conducting audits

9. not to accept any inducement, commission, gift or any other benefit from any interested party while conducting audits

10. not to communicate false, erroneous or misleading information that may compromise the integrity of any audit

11. not to act in any way that would prejudice the reputation of the Ministry or the DAA

12. to co-operate fully with any inquiry in the event of a complaint about his/her performance as an auditor, or any alleged breach of this code

13. to make clear to providers that the decision about certification status rests solely with the Director-General of Health and that the DAA is not able to make comment or support an appeal concerning the determination made regarding certification

14. to accept that providers have the freedom to select and change their DAA, and not to place any undue influence on providers when they are making a decision in this respect

15. to refrain from making any comments on any auditors or DAA, including Ministry or DHB auditors.


Appendix 4: Annual Self-declaration Form

DAA annual declaration and reporting requirements

Each DAA is required to complete the following form and return it to HealthCERT before 29 January each year.

Declaration

Name of DAA.....................................................................................................................

Person completing this form ..............................................................................................

Contact details ................................................................................................................... I declare on behalf of the above DAA that:

Yes No

1. An internal audit of the DAA has been undertaken in the last calendar year

2. An internal appeals system remains in place and is documented and conveyed to clients in writing

3. A conflict-of-interest process is established which prevents auditors (staff or contractors) providing consultancy services or education to a client that holds a contract with this DAA for audit services

4. The Ministry holds an up-to-date auditor register for all staff and contractors that undertake work on behalf of this DAA (including date of yearly performance appraisal and witnessed audit)

5. This DAA has verified the auditor qualifications and competence of auditors to meet ISO 19011 and ISO 17021 requirements

I,................................................................ , declare that the above information is correct.

Signed:........................................................................ Date: .........................................

Reporting requirements associated with this declaration

If you answered No to any of the above, please provide full details and append to this declaration. Additionally, please provide the following information:

1. Details of what the internal audit of your DAA included, results of the internal audit and an action plan for the coming year.

2. A copy of your internal appeals process and details of all complaints that have been received by your DAA over the past year and the actions taken to remedy the complaints (include copies of correspondence to clients).

3. A copy of your conflict-of-interest policy and process, together with evidence that this policy is implemented.


4. An updated auditor register, if the current register held by the Ministry is out-of-date.

5. The process used by your DAA to verify auditor qualifications and competence, including your orientation programme for new staff.


Appendix 5: Progress Report Form

Progress Report Standard Form

DAA: Date Verified:

Provider:

Facility Name(s):

Addresses:

Types of Services Certified:(Please tick)

Hospital Services that are:

[ ] Surgical Services [ ] Maternity Services [ ] Mental Health Services [ ] Geriatric Services [ ] Children’s Health Services [ ] Medical Services

Age Related Services that are:

[ ] Rest Home Care

Residential Disability Services that are: [ ] Intellectual [ ] Physical [ ] Psychiatric [ ] Sensory

Condition of Certification: (please copy condition in exact wording and use a separate form for each condition reported on) Outcome:

Standard & Criteria reference (1 line/criterion)

Audit Evidence (DAA completes) Form of evidence (e.g. documents, interview, onsite observation etc)

Level of attainment (CI, FA, PA, UA)

Level of Risk for PA/UA

If the outcome has resulted in Full Attainment and the provider would like a summary statement published on the Ministry website, please provide a summary statement below: (Leave this blank if no summary statement is required for the website)

Please confirm that: Yes No The provider has been consulted in the development of the summary statement The provider is in agreement with the summary statement The summary statement is factual and correctly reflects a change in the level of attainment from the condition on the certificate


Suggested Amendments to Certification Schedule: (Based on the above findings, please detail any amendments you believe should be considered) DECLARATION I, (full name of agent or employee of the DAA) [ ] (occupation) [ ] of (place) [ ] hereby submit this progress report pursuant to section 28 of the Health and Disability Services (Safety) Act 2001 on behalf of [ ] an auditing agency designated under section 32 of the Act. I confirm that the requirements of the condition(s) identified have been fulfilled and that the evidence sighted and/or

collected supports the outcome described above. ⎕

The addendum summary has been developed in consultation with the provider ⎕

Dated this [ ] day of [ ] [ ] DAA Auditor:

Signature:

Please email the completed form to HealthCERT

Advisor Comments (HealthCERT only)

Advisor Name

Date:

Further Action (HealthCERT use only) Notify DAA and File Amended Schedule

New Condition

Other


Appendix 6: Gazette Notice: ‘Designation of Auditing Agency’

Designation of auditing agency

Pursuant to section 32 of the Health and Disability Services (Safety) Act 2001 (‘the Act’), I, XXXXX, Deputy Director-General, Sector Accountability and Funding, Ministry of Health (‘the Ministry’), under delegation from the Director-General of Health, designate XXXXX(‘DAA’) to audit the provision or likely future provision of the following kinds of Health Care Services:

hospital care (as defined in section 4(1) of the Act)

rest home care (as defined in section 6(2) of the Act)

residential disability care (as defined in section 4(1) of the Act). This designation is subject to the following conditions:

1. The DAA must comply with the requirements of the DAA handbook issued by the Ministry and updated from time to time.

2. Promptly after giving a certified provider or prospective provider an audit report, the DAA must:

a. complete the Ministry audit report tool and provide an electronic copy to the Ministry

b. provide a summary of the audit report to the Ministry (refer to condition 9).

3. The DAA must provide any information about the auditing of health care services pursuant to the Act if requested in writing by the Ministry.

4. During the term of the DAA’s designation the DAA will allow the Ministry to audit or to commission the undertaking of audits or reviews of the DAA. This could also include attending audits being undertaken by the DAA. The Ministry may or may not notify the DAA of any audit or review.

5. The DAA must immediately notify the Ministry in writing of any significant change to the DAA, including but not restricted to:

a. any change in ownership and/or control of the legal entity

b. any change in management personnel

c. any change to the Auditor Register (refer to condition 7)

d. any change in the status of any third-party accreditation the DAA may hold, including evidence of such accreditation and copies of any third-party accreditation audit reports or notifications in respect of their accreditation.

6. The DAA must conduct as a minimum at least one annual:

a. internal audit that focuses on the DAA’s auditing activities undertaken pursuant to the Act, together with a compliance audit against the requirements of the DAA as set out in the Act; and



b. management review in respect of the DAA’s programmes operated pursuant to the Act.

7. The DAA shall at all times operate an internal appeals system which is documented and conveyed in writing to all clients. Auditable records of the facts and outcomes of all client appeals shall be maintained by the DAA. The DAA must provide these records to the Ministry when requested in writing by the Ministry.

8. The DAA must provide in a timely manner when requested by the Ministry in writing the details of the name, auditing qualifications and experience, and, if relevant, the area of clinical or service competency of each auditor or technical expert approved by the DAA to undertake audits pursuant to the Act.

9. The DAA must provide all documentation to the Ministry in the form prescribed by the Ministry.

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