Pursuant to section 32 of the Health and Disability Services (Safety) Act 2001 ("the Act"), I, Mark Richards, Acting Deputy Director-General, Regulation & Governance Directorate, Ministry of Health ("the Ministry"), under delegation from the Director-General of Health, designate Global-Mark Pty Limited (the "Designated Auditing Agency" (DAA)) to audit the provision or likely future provision of the following kind of health care service:
- New Zealand Fertility Services.
This designation is subject to the following conditions:
1. The DAA must comply with the relevant 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:
- complete the Ministry of Health Audit Report Tool and provide an electronic copy to the Ministry; and
- 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 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:
- any change in ownership and/or control of the legal entity;
- any change in management personnel;
- any change in pricing;
- any change to the Auditor Register (refer to condition 8); and
- 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:
- 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
- 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 in writing to the Ministry when requested by the Ministry.
8. The DAA must provide in writing, in a timely manner when requested by the Ministry, 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.
10. The DAA must publish information in relation to its pricing and fee structure and ensure that information
is available across the sector to enable service providers to obtain and compare prices. A DAA must, at a minimum, publish the information on its website and/or in a brochure. The Ministry intends to publish the information on its website.
11. The DAA must hold third party accreditation with a Ministry approved third party accreditation body.
This designation expires on 18 May 2013.
Dated at Wellington this 18th day of May 2010.
MARK RICHARDS, Acting Deputy Director-General, Regulation & Governance Directorate, Ministry of Health.